Adding Regenerative medicine to your practice.

[lonelobo]

Of course. Regenerative medicine is a cash-only pipe dream for most people. Even if its done at cost, most people I see cannot afford it.

I give them the option of traditional covered treatments as well as not-covered treatments I think may help. Patient choice.

Hmm..... so you perform treatments that directly contradict one another

---

Members don't see this ad.

 

[drusso]

its not PNE, but what does your wife do again?

Mostly shame resiliency therapy. Helping people reconcile the cumulative effects of a lifetime of poor decision making with the present-day consequences those choices have caused...and throws in some wisdom from Ayn Rand...

People with chronic pain harbor a lot of shame.

Shame Resilience Theory: Advice From Brené Brown

We all experience shame. See Brené Brown’s take on shame resilience theory.

positivepsychology.com

 

[Ferrismonk]

Hmm..... so you perform treatments that directly contradict one another

Oh come on.

 

[lonelobo]

Oh come on.

So you drank the Kool-Aid and apply when patients have cash to pay for it , but no Cash then No Kool-aid beliefs?

 

[Ferrismonk]

So you drank the Kool-Aid and apply when patients have cash to pay for it , but no Cash then No Kool-aid beliefs?

Yeah, I only do procedures I get paid for. I'm mean like that.

I also tell people to try magnesium and tumeric. I order PoDiaPN and Metanx (These aren't ever covered). These are cash-pay treatments as well. No cash, no goodies.

 

[lonelobo]

At least your honest about taking people's money for unproven treatments

 

[Baron Samedi]

Hmm..... so you perform treatments that directly contradict one another

Sometimes Internists give antihypertensives and sometimes they give pressors....completely contradictory!

I'm no Regenerative medicine apologist, but that's an unreasonable argument. Different treatment strategies for different situations.

 

[Ducttape]

er...

decision to give those medications is based on an objective measure - ie blood pressure.

regenerative medicine advocates posit that their treatment is superior to current standard of care and to use instead of said treatment. your analogy is not apropos.

 

[Baron Samedi]

But there can be some objectivity to it, right?

Pain is acute or initial injection -- trial corticosteroids
Pain is more chronic and failed injections -- consider regenerative medicine

If people are jumping straight to regenerative medicine on someone with a few weeks of clear cut subacromial bursitis without trying a steroid first, I find that questionable. But if that same person has tried a CSI, rehab plan, etc and still has pain a months later it might be reasonable to offer PRP or something. They're contradictory treatment strategies but I would argue it makes sense in that situation.

 

[Ferrismonk]

But there can be some objectivity to it, right?

Pain is acute or initial injection -- trial corticosteroids
Pain is more chronic and failed injections -- consider regenerative medicine

If people are jumping straight to regenerative medicine on someone with a few weeks of clear cut subacromial bursitis without trying a steroid first, I find that questionable. But if that same person has tried a CSI, rehab plan, etc and still has pain a months later it might be reasonable to offer PRP or something. They're contradictory treatment strategies but I would argue it makes sense in that situation.

Or if there are contraindications to steroids.

For something such as bursitis or shoulder pain, my treatment plan is something like this:

 

[Ducttape]

is pain now an objective finding? are we going back to the days of pain as the 5th vital sign?

after re-reviewing the Regenexx website, it seems that Centeno believes that any treatment not regenerative should not be undertaken as it is harmful.

im now going on an tangent away from the analogy that you posited:

I'm obviously interpreting treatment strategies incorrectly, because drusso agreed with your plan, but I thought that regenerative medicine and PRP injections would be more likely to be beneficial and less harmful than steroid injections for acute sprains/strains - promote healing et al.

 

[SommeRiver]

Or if there are contraindications to steroids.

For something such as bursitis or shoulder pain, my treatment plan is something like this:
View attachment 289116

Sorry, but everything is under traditional except PRP/BMAC.

 

[SommeRiver]

But there can be some objectivity to it, right?

Pain is acute or initial injection -- trial corticosteroids
Pain is more chronic and failed injections -- consider regenerative medicine

If people are jumping straight to regenerative medicine on someone with a few weeks of clear cut subacromial bursitis without trying a steroid first, I find that questionable. But if that same person has tried a CSI, rehab plan, etc and still has pain a months later it might be reasonable to offer PRP or something. They're contradictory treatment strategies but I would argue it makes sense in that situation.

The problem is EVERYONE who does orthobiologics uses them as first line intervention.

 

[lonelobo]

Simpler decision tree

Regenerative

How much Cash will this pt
be willing to fork over for unproven therapy

 

[drusso]

is pain now an objective finding? are we going back to the days of pain as the 5th vital sign?

after re-reviewing the Regenexx website, it seems that Centeno believes that any treatment not regenerative should not be undertaken as it is harmful.

im now going on an tangent away from the analogy that you posited:

I'm obviously interpreting treatment strategies incorrectly, because drusso agreed with your plan, but I thought that regenerative medicine and PRP injections would be more likely to be beneficial and less harmful than steroid injections for acute sprains/strains - promote healing et al.

1) You don't treat "pain" with orthobiologics. You treat tendinopathy, sprains, arthritis, etc. The target tissue, patient host factors, and autologous tissue product all interact together. That's why regen is evolving into its own field/specialty. You can't just say, "I degenerate on Monday, Wednesday, Fridays and regenerate on Tuesdays and Thursdays."

2) Obviously, "it depends." There are liberal and conservative philosophies about how to use orthobiologics versus traditional IPM modalities. If I see an elderly, obese, metabolically-deranged female with bone-on-bone knee OA I'm likely not going to recommend a trial of orthobiologics first. Likely steer that patient to genicular RF or arthroplasty. Admittedly. this is a very conservative interpretation. More liberal practitioners might take a stab at it.

DEFINE_ME

Here is what we believe:

Medical conservatives are not nihilists. We appreciate progress and laud scientific gains that have transformed once deadly diseases, such as AIDS and many forms of cancer, into manageable chronic conditions. And in public health, we recognize that reducing exposure to tobacco smoke and removal of trans-fats from the food supply have contributed to the secular decline in cardiac event rates. Indeed, medical science has made this era a great time to live.

The medical conservative, however, recognizes that many developments promoted as medical advances offer, at best, marginal benefits. We do not ignore value. . . . The medical conservative adopts new therapies when the benefit is clear and the evidence strong and unbiased.

 

[Ferrismonk]

Simpler decision tree

Regenerative

How much Cash will this pt
be willing to fork over for unproven therapy

No doubt many people are like that, but that's not my tree.

Sorry, but everything is under traditional except PRP/BMAC.

I disagree. The goal of Regenerative medicine is to promote healing. That includes Rest/Ice/diet/nutrition/PT. There's a switch that happens where the goal becomes not healing the tendon/ligament/joint/whatever, but to decrease pain and improve function. Even if that means causing more injury or degrading/replacing the tendon/ligament/joint/whatever.

 

[Baron Samedi]

The miracle that is AmnioFix. Same patient -- first picture is baseline, second picture is a few weeks after injection.

 

[DoYouEvenLiftBro]

View attachment 288971

Joint space is the same just different penetration of the X-ray

 

[SommeRiver]

I disagree. The goal of Regenerative medicine is to promote healing. That includes Rest/Ice/diet/nutrition/PT. There's a switch that happens where the goal becomes not healing the tendon/ligament/joint/whatever, but to decrease pain and improve function. Even if that means causing more injury or degrading/replacing the tendon/ligament/joint/whatever.

Nope.

This isn't a residency application essay.

 

[drusso]

Narwal the puppy disagrees with you.

Randomized, double-blind, controlled trial, phase III, to evaluate the use of platelet-rich plasma versus hyaluronic acid in hip coxarthrosis. - PubMed - NCBI https://ncbi.nlm.nih.gov/pubmed/31902736

• Format: Abstract

Send to




Rev Esp Cir Ortop Traumatol. 2020 Jan 2. pii: S1888-4415(19)30149-3. doi: 10.1016/j.recot.2019.09.008. [Epub ahead of print]
Randomized, double-blind, controlled trial, phase III, to evaluate the use of platelet-rich plasma versus hyaluronic acid in hip coxarthrosis.
[Article in English, Spanish]
Villanova-López MM1, Núñez-Núñez M2, Fernández-Prieto D3, González-López C3, García-Donaire J4, Pérez-Pérez A3, Sandoval Fernández Del Castillo S5, Murillo-Izquierdo M5, Camean-Fernández M5, Gutiérrez-Pizarraya A5, Navas-Iglesias N6, Roca-Ruiz LJ3, Calleja-Hernández MÁ5, Ballester-Alfaro JJ7.
Author information

Abstract
AIMS OF THE STUDY:
To compare efficacy and safety of a home-made platelet-rich plasma (PRP) solution versus hyaluronic acid in patients with hip osteoarthritis not responding to conservative treatment and to correlate cellular composition of PRP to clinical outcomes.
MATERIAL AND METHODS:
This is a phase III clinical trial, double-blinded, controlled and randomised into two treatment groups (PRP and hyaluronic acid). Patients received one hip ultrasound-guided injection. Follow up was 12 months. Pain was assessed using VAS score, HHS and WOMAC were used as functional scores, analgesia, adverse events, cellular components (PRP group) in peripheral blood and in PRP were recorded. Clinical response was assessed using OARSI criteria.
RESULTS:
Seventy-four patients were included. Both groups improved in VAS, WOMAC and HHS score and reduced the amount of analgesia (p<.05). Significant differences were seen at 1 year post-treatment in HHS score (PRP 70.9 [3.7-58], hyaluronic acid 60.2[43-74.2] p<.05). No adverse events were observed in none of the groups. Platelet concentration was different between responders and non-responders (at 1 month, non-responders 449[438-578] x103 platelets/μl versus responders 565 [481-666] x103 platelets/μl, p<.044). There was a correlation between leukocytes concentration and clinical scores (VAS at six months, r=0.748, p<.013, WOMAC at 6 months r=0.748, p <.013). Patients with early stage hip OA showed higher response rate to PRP compared with late stage (11.51 OR, 95%CI 2.34-50.65, p<.03).
CONCLUSIONS:
Platelet-rich plasma injection improved hip function, reduced pain and the use of analgesia. It is important to bear in mind the cellular composition in order to achieve a better clinical response.
Copyright © 2019 SECOT. Publicado por Elsevier España, S.L.U. All rights reserved.
KEYWORDS:
Coxarthrosis; Coxartrosis; Factores de crecimiento; Growth factors; Hyaluronic acid; Plasma rico plaquetas; Platelet rich plasma; Ácido hialurónico

 

[Ducttape]

a better study than most others.

interestingly, only 1 assessment tool showed long term benefit, the HHS. the VAS (notoriously inaccurate, I agree) and the WOMAC did not.

these findings do disagree with some of those meta-analyses that have been published previously (Platelet rich plasma versus hyaluronic acid in patients with hip osteoarthritis: A meta-analysis of randomized controlled trials for example)

no placebo group, would have been nice.

not a home run - almost a double - but it is moving the data in the right direction...

 

[drusso]

a better study than most others.

interestingly, only 1 assessment tool showed long term benefit, the HHS. the VAS (notoriously inaccurate, I agree) and the WOMAC did not.

these findings do disagree with some of those meta-analyses that have been published previously (Platelet rich plasma versus hyaluronic acid in patients with hip osteoarthritis: A meta-analysis of randomized controlled trials for example)

no placebo group, would have been nice.

not a home run - almost a double - but it is moving the data in the right direction...

Isn't HA a placebo?

 

[Ducttape]

is it saline or other inactive substance?

interesting that the article states that HA patients also improved: Both groups improved in VAS, WOMAC and HHS score and reduced the amount of analgesia (p<.05).

 

[drusso]

is it saline or other inactive substance?

interesting that the article states that HA patients also improved: Both groups improved in VAS, WOMAC and HHS score and reduced the amount of analgesia (p<.05).

Does anyone doubt that PRP is inert? The basic science definitely shows active ingredients in PRP. Now, I think that the field has accepted that it is not inert and now wants to know if it is non-inferior.

 

[Ducttape]

no-one mentioned PRP is inert. if anything, you need an inert substance as the placebo arm. technically, this study is not comparing PRP to true placebo.


and non-inferior is ultimately not helpful. that is just grounds to continue current practice - ie cash pay for those who have expendable income.

you want evidence that shows superior benefit.

addendum - this study does suggest that the patient population that I see will not benefit from PRP.... Patients with early stage hip OA showed higher response rate to PRP compared with late stage (11.51 OR, 95%CI 2.34-50.65, p<.03).

 

[drusso]

no-one mentioned PRP is inert. if anything, you need an inert substance as the placebo arm. technically, this study is not comparing PRP to true placebo.


and non-inferior is ultimately not helpful. that is just grounds to continue current practice - ie cash pay for those who have expendable income.

you want evidence that shows superior benefit.

addendum - this study does suggest that the patient population that I see will not benefit from PRP.... Patients with early stage hip OA showed higher response rate to PRP compared with late stage (11.51 OR, 95%CI 2.34-50.65, p<.03).

My experience with late-stage hip OA and PRP has been poor.

Why is non-inferior not helpful? Patients want options. Some people don't want steroids.

 

[Doctodd]

Sometimes late stage hip OA doesn’t respond well to anything except hip replacement

 

[deleted993114]

Randomized, double-blind, controlled trial, phase III, to evaluate the use of platelet-rich plasma versus hyaluronic acid in hip coxarthrosis. - PubMed - NCBI https://ncbi.nlm.nih.gov/pubmed/31902736

• Format: Abstract

Send to




Rev Esp Cir Ortop Traumatol. 2020 Jan 2. pii: S1888-4415(19)30149-3. doi: 10.1016/j.recot.2019.09.008. [Epub ahead of print]
Randomized, double-blind, controlled trial, phase III, to evaluate the use of platelet-rich plasma versus hyaluronic acid in hip coxarthrosis.
[Article in English, Spanish]
Villanova-López MM1, Núñez-Núñez M2, Fernández-Prieto D3, González-López C3, García-Donaire J4, Pérez-Pérez A3, Sandoval Fernández Del Castillo S5, Murillo-Izquierdo M5, Camean-Fernández M5, Gutiérrez-Pizarraya A5, Navas-Iglesias N6, Roca-Ruiz LJ3, Calleja-Hernández MÁ5, Ballester-Alfaro JJ7.
Author information

Abstract
AIMS OF THE STUDY:
To compare efficacy and safety of a home-made platelet-rich plasma (PRP) solution versus hyaluronic acid in patients with hip osteoarthritis not responding to conservative treatment and to correlate cellular composition of PRP to clinical outcomes.
MATERIAL AND METHODS:
This is a phase III clinical trial, double-blinded, controlled and randomised into two treatment groups (PRP and hyaluronic acid). Patients received one hip ultrasound-guided injection. Follow up was 12 months. Pain was assessed using VAS score, HHS and WOMAC were used as functional scores, analgesia, adverse events, cellular components (PRP group) in peripheral blood and in PRP were recorded. Clinical response was assessed using OARSI criteria.
RESULTS:
Seventy-four patients were included. Both groups improved in VAS, WOMAC and HHS score and reduced the amount of analgesia (p<.05). Significant differences were seen at 1 year post-treatment in HHS score (PRP 70.9 [3.7-58], hyaluronic acid 60.2[43-74.2] p<.05). No adverse events were observed in none of the groups. Platelet concentration was different between responders and non-responders (at 1 month, non-responders 449[438-578] x103 platelets/μl versus responders 565 [481-666] x103 platelets/μl, p<.044). There was a correlation between leukocytes concentration and clinical scores (VAS at six months, r=0.748, p<.013, WOMAC at 6 months r=0.748, p <.013). Patients with early stage hip OA showed higher response rate to PRP compared with late stage (11.51 OR, 95%CI 2.34-50.65, p<.03).
CONCLUSIONS:
Platelet-rich plasma injection improved hip function, reduced pain and the use of analgesia. It is important to bear in mind the cellular composition in order to achieve a better clinical response.
Copyright © 2019 SECOT. Publicado por Elsevier España, S.L.U. All rights reserved.
KEYWORDS:
Coxarthrosis; Coxartrosis; Factores de crecimiento; Growth factors; Hyaluronic acid; Plasma rico plaquetas; Platelet rich plasma; Ácido hialurónico

Open label, no control group. Multiple measures of outcome without statistical adjustment for multiple comparisons, Note "better outcomes" with "early" vs "late" OA, with no description of what radiographically and clinically those terms mean in their study.

It is kind of like the patients with "stenosis" who respond the the MILD treatment and X-stop. When you look at the films NONE of those patients meet radiographic criteria for stenosis.

Garbage in- garbage out.

 

[drusso]

no-one mentioned PRP is inert. if anything, you need an inert substance as the placebo arm. technically, this study is not comparing PRP to true placebo.


and non-inferior is ultimately not helpful. that is just grounds to continue current practice - ie cash pay for those who have expendable income.

you want evidence that shows superior benefit.

addendum - this study does suggest that the patient population that I see will not benefit from PRP.... Patients with early stage hip OA showed higher response rate to PRP compared with late stage (11.51 OR, 95%CI 2.34-50.65, p<.03).

Arthroscopy. 2020 Jan 6. pii: S0749-8063(19)30885-0. doi: 10.1016/j.arthro.2019.09.043. [Epub ahead of print]
Different Intra-articular Injections as Therapy for Hip Osteoarthritis: A Systematic Review and Network Meta-analysis.
Zhao Z1, Ma JX1, Ma XL2.
Author information
1Department of Orthopaedics, Tianjin Hospital, Tianjin, China.2Department of Orthopaedics, Tianjin Hospital, Tianjin, China. Electronic address: [email protected].
Abstract
PURPOSE:
This systematic review and network meta-analysis aimed to compare the clinical outcomes between 4 intra-articular injections (platelet-rich plasma [PRP], hyaluronic acid [HA], corticosteroid [CS], and HA plus PRP) for hip osteoarthritis (OA).
METHODS:
We performed a systematic literature search in PubMed, Embase, Web of Science, and the Cochrane database through April 2018 to identify any randomized controlled trials that evaluated the clinical efficacy of HA, PRP, CS, HA-plus-PRP, and control treatments for hip OA. Baseline information-country, mean age, number of patients, and Kellgren-Lawrence grade of hip OA in the treatment and control groups-was collected. The primary outcome was the visual analog scale (VAS) score at 1, 3, 6, and 12 months after injection.
RESULTS:
We included 11 randomized controlled trials with a total of 1,060 patients. The Kellgren-Lawrence grades of the treatment and control groups were similar in individual studies. The pair-wise meta-analysis indicated that CS and HA were superior to the control group in reducing the VAS score at 1 month and 3 months (P < .05) and that CS was superior to HA in reducing the VAS score at 1 month (P < .05). The network meta-analysis results indicated that HA and CS exhibited a beneficial role in reducing the VAS score at 1 month. CS achieved the lowest value for the surface under the cumulative ranking curve (SUCRA) for the VAS score at 1 month (0.23), and the SUCRA values of the 5 interventions showed that PRP achieved the lowest SUCRA value for the VAS score at 6 months (0.53).
CONCLUSIONS:
CS injections are recommended as the most efficient agent in hip OA patients in the short term. Moreover, PRP is reported to have the highest rank for pain relief for up to 6 months. Considering the limitations of this meta-analysis, future direct comparisons with more samples are needed.
LEVEL OF EVIDENCE:
Level II, meta-analysis of Level I and II studies.
Copyright © 2019 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.
PMID: 31919027 DOI: 10.1016/j.arthro.2019.09.043

 

[Ducttape]

I like your other original non-GIGO studies.

please keep putting those up.

 

[deleted993114]

Joint space is the same just different penetration of the X-ray

It is the slight of hand by chiropractors. No one in their right mind would believe that PRP would change joint spaces. Even for those who would believe so (which is crazy), there is no way in hell that could happen in a few weeks.

The problem with pain mgmt. (which has plagued us since the beginning) is that physicians in pain management embrace and employ treatment entities that have very little, if any, objective data to justify its implementation.

One would think that the pain management community would learn, but it is a story that repeats itself, over and over again. One would hope (as in rational medicine) there would be good data from well performed studies in good journals before docs would reccommend treatments for patients. That hope is never realized in our world. So practitioners go from one unproven technology to another, always seeking to employ "the latest and greatest" treatment far before valid science has had a chance to evaluate whether it actually works (or not).

 

[Ducttape]

I'm not sure you will ever be able to quantify and obtain objective data for a subjective experience.

I remember trying to get Qutenza patch approved in the system. I noted that the patch provided 30% improvement in VAS. a nephrologist on the panel said that was a laughable result, and if they had a renal drug that only lead to 30% improvement. it would never get FDA approval...

 

[drusso]

I'm not sure you will ever be able to quantify and obtain objective data for a subjective experience.

I remember trying to get Qutenza patch approved in the system. I noted that the patch provided 30% improvement in VAS. a nephrologist on the panel said that was a laughable result, and if they had a renal drug that only lead to 30% improvement. it would never get FDA approval...

What if it were a cancer drug that showed a 30% improvement in overall mortality? It would be a blockbuster hit!

 

[Ferrismonk]

What if it were a cancer drug that showed a 30% improvement in overall mortality? It would be a blockbuster hit!

At >$100K per year...

 

[Ferrismonk]

Has anybody had success billing Tricare for PRP in the knee since they added coverage late last year?

 

[drusso]

I like your other original non-GIGO studies.

please keep putting those up.

@lobelsteve

Arthroscopy. 2019 Jan;35(1):106-117. doi: 10.1016/j.arthro.2018.06.035.
Intra-articular Injection of Platelet-Rich Plasma Is Superior to Hyaluronic Acid or Saline Solution in the Treatment of Mild to Moderate Knee Osteoarthritis: A Randomized, Double-Blind, Triple-Parallel, Placebo-Controlled Clinical Trial.
Lin KY1, Yang CC2, Hsu CJ3, Yeh ML4, Renn JH5.
Author information

Abstract
PURPOSE:
To prospectively compare the efficacy of intra-articular injections of platelet-rich plasma (PRP) and hyaluronic acid (HA) with a sham control group (normal saline solution [NS]) for knee osteoarthritis in a randomized, dose-controlled, placebo-controlled, double-blind, triple-parallel clinical trial.
METHODS:
A total of 87 osteoarthritic knees (53 patients) were randomly assigned to 1 of 3 groups receiving 3 weekly injections of either leukocyte-poor PRP (31 knees), HA (29 knees), or NS (27 knees). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score and International Knee Documentation Committee (IKDC) subjective score were collected at baseline and at 1, 2, 6, and 12 months after treatment. Data were analyzed using generalized estimating equations.
RESULTS:
All 3 groups showed statistically significant improvements in both outcome measures at 1 month; however, only the PRP group sustained the significant improvement in both the WOMAC score (63.71 ± 20.67, increased by 21%) and IKDC score (49.93 ± 17.74, increased by 40%) at 12 months. For the intergroup comparison, except for the first month, there was a statistically significant difference between the PRP and NS groups in both scores throughout the study duration (regression coefficients of 8.72 [P = .0015], 7.94 [P = .0155], and 11.92 [P = .0014] at 2, 6, and 12 months, respectively, for WOMAC score, and 9.1 [P = .0001], 10.28 [P = .0002], and 13.97 [P < .0001], respectively, for IKDC score). There was no significant difference in both functional outcomes between the HA and NS groups at any time point. Only the PRP group reached the minimal clinically important difference in the WOMAC score at every evaluation (15%, 21%, 18%, and 21% at 1, 2, 6, and 12 months, respectively) and the minimal clinically important difference in the IKDC score at 6 months (improvement of 11.6).
CONCLUSIONS:
Intra-articular injections of leukocyte-poor PRP can provide clinically significant functional improvement for at least 1 year in patients with mild to moderate osteoarthritis of the knee.
LEVEL OF EVIDENCE:
Level I, randomized controlled single-center trial.
Copyright © 2019 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

 

[lobelsteve]

@lobelsteve

Arthroscopy. 2019 Jan;35(1):106-117. doi: 10.1016/j.arthro.2018.06.035.
Intra-articular Injection of Platelet-Rich Plasma Is Superior to Hyaluronic Acid or Saline Solution in the Treatment of Mild to Moderate Knee Osteoarthritis: A Randomized, Double-Blind, Triple-Parallel, Placebo-Controlled Clinical Trial.
Lin KY1, Yang CC2, Hsu CJ3, Yeh ML4, Renn JH5.
Author information

Abstract
PURPOSE:
To prospectively compare the efficacy of intra-articular injections of platelet-rich plasma (PRP) and hyaluronic acid (HA) with a sham control group (normal saline solution [NS]) for knee osteoarthritis in a randomized, dose-controlled, placebo-controlled, double-blind, triple-parallel clinical trial.
METHODS:
A total of 87 osteoarthritic knees (53 patients) were randomly assigned to 1 of 3 groups receiving 3 weekly injections of either leukocyte-poor PRP (31 knees), HA (29 knees), or NS (27 knees). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score and International Knee Documentation Committee (IKDC) subjective score were collected at baseline and at 1, 2, 6, and 12 months after treatment. Data were analyzed using generalized estimating equations.
RESULTS:
All 3 groups showed statistically significant improvements in both outcome measures at 1 month; however, only the PRP group sustained the significant improvement in both the WOMAC score (63.71 ± 20.67, increased by 21%) and IKDC score (49.93 ± 17.74, increased by 40%) at 12 months. For the intergroup comparison, except for the first month, there was a statistically significant difference between the PRP and NS groups in both scores throughout the study duration (regression coefficients of 8.72 [P = .0015], 7.94 [P = .0155], and 11.92 [P = .0014] at 2, 6, and 12 months, respectively, for WOMAC score, and 9.1 [P = .0001], 10.28 [P = .0002], and 13.97 [P < .0001], respectively, for IKDC score). There was no significant difference in both functional outcomes between the HA and NS groups at any time point. Only the PRP group reached the minimal clinically important difference in the WOMAC score at every evaluation (15%, 21%, 18%, and 21% at 1, 2, 6, and 12 months, respectively) and the minimal clinically important difference in the IKDC score at 6 months (improvement of 11.6).
CONCLUSIONS:
Intra-articular injections of leukocyte-poor PRP can provide clinically significant functional improvement for at least 1 year in patients with mild to moderate osteoarthritis of the knee.
LEVEL OF EVIDENCE:
Level I, randomized controlled single-center trial.
Copyright © 2019 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Please get all the categorical data. Repeat the study with 100 in each arm and we’ve got some thing. I really need to know if the people had both knees injected always got the same medicine or if they got different medicines in each knee.

 

[drusso]

Please get all the categorical data. Repeat the study with 100 in each arm and we’ve got some thing. I really need to know if the people had both knees injected always got the same medicine or if they got different medicines in each knee.

Why require such a high bar for such a benign autologous intervention? It's not like we're shoving cement into people's backs...you need an RCT to justify sparing people the harmful effects of corticosteroids on cartilage?

 

[lobelsteve]

Why require such a high bar for such a benign autologous intervention? It's not like we're shoving cement into people's backs...you need an RCT to justify sparing people the harmful effects of corticosteroids on cartilage?

Need proof it is not chance. Like Vertos study.

 

[Doctodd]

At >$100K per year...

they went bankrupt....it was DNDN

 

[drusso]

Please get all the categorical data. Repeat the study with 100 in each arm and we’ve got some thing. I really need to know if the people had both knees injected always got the same medicine or if they got different medicines in each knee.

When you're ready to do something about that knee, let me know...

Equivalent 10-Year Outcomes After Implantation of Autologous Bone Marrow–Derived Mesenchymal Stem Cells Versus Autologous Chondrocyte Implantation for Chondral Defects of the Knee


Show all authors
Alex Quok An Teo, MBBChir (Cantab), MA (Hons), MRCS (Eng), Keng Lin Wong, MBBS, MRCSEd, MMed (Orth), MCI (NUS), FRCSEd (Orth), Liang Shen, PhD, ...
First Published August 21, 2019 Research Article Find in PubMed
https://doi.org/10.1177/0363546519867933

Article information

Abstract
Background:
The use of bone marrow–derived mesenchymal stem cells (BMSCs) in cartilage repair procedures circumvents some of the limitations of autologous chondrocyte implantation (ACI), but long-term outcomes for this newer procedure are lacking. The authors previously reported comparable outcomes for the 2 procedures at 2-year follow-up.
Purpose/Hypothesis:
The purpose was to compare the long-term clinical outcomes of ACI versus BMSCs. It was hypothesized that there would be no significant difference between the groups in terms of patient-reported outcome scores and safety outcomes at 10-year follow-up.
Study Design:
Cohort study; Level of evidence, 2.
Methods:
Seventy-two patients who underwent either ACI or BMSC implantation—matched in terms of age and lesion site— were followed up to a median of at least 10 years. Patients were assessed with the 36-item Short Form Health Survey (SF-36), the International Knee Documentation Committee knee evaluation form, the Lysholm Knee Score, and the Tegner Activity Scale. In addition, information was obtained regarding any additional surgical procedures as well as safety data, with particular attention to infection and tumor formation.
Results:
There was an improvement in all patient-reported outcomes scores apart from the Mental Component Summary of the SF-36 after cartilage repair surgery. There was no significant difference in any of the patient-reported outcomes between cohorts at any time point. Six and 5 patients in the ACI and BMSC groups, respectively, underwent subsequent surgical procedures, including 1 total knee replacement in the BMSC group. None of the patients in either group developed any deep infection or tumor within the follow-up period.
Conclusion:
BMSC implantation used for the treatment of chondral defects of the knee appears to result in equivalent clinical outcomes to first-generation ACI at up to 10 years, with no apparent increased tumor formation risk.
Keywords autologous chondrocyte implantation, bone marrow–derived stem cells, knee articular cartilage, articular cartilage resurfacing

 

[Ducttape]

nice.

how does that compare to conservative non-operative therapy?

or standard of therapy from what ortho appears to do - which is TKR?

 

[drusso]

nice.

how does that compare to conservative non-operative therapy?

or standard of therapy from what ortho appears to do - which is TKR?

What's your rush sending people off to TKR? Get them pre-qualified for a DRG or genicular RFA?

 

[Ducttape]

don't deflect.

the question: how these procedures compare to standard of care?

a simple research question that should show clinically significant benefit over conservative non-operative and standard of care operative therapy and tell us that these injections are superior to both.


emphasized was that apparently only 1 patient got knee replacement surgery. but the average ages at 10 year follow up was 49.6 and 52.6 years of age - not sure how many of these patients would have been candidates for TKR based on age.

for me, cut off of 65 years did mean that elderly patients were not involved in study. I wonder if knee replacement surgery rates would have been higher if the age to start were on average at an age that that would be a consideration, such as 50. the average age for starting for the ACI group was what, 38?.

 

[lobelsteve]

Curb Your Enthusiasm about Stem Cells for Knee OA - OrthoBuzz

Mark Miller, MD is a professor of orthopaedic surgery at the University of Virginia, founder and co-director of the Miller Review Courses, and former deputy

orthobuzz.jbjs.org

 

[drusso]

Fantastic job by an incredible group of talented physicians and thought-leaders in this space. A relentless search for better ways...

 

[Ligament]

Fantastic job by an incredible group of talented physicians and thought-leaders in this space. A relentless search for better ways...

View attachment 294224

Can anybody post the PDF of this please?

 

[drusso]

Curb Your Enthusiasm about Stem Cells for Knee OA - OrthoBuzz

Mark Miller, MD is a professor of orthopaedic surgery at the University of Virginia, founder and co-director of the Miller Review Courses, and former deputy

orthobuzz.jbjs.org

What's the Research On Knee Stem Cell Therapy?

Dr. Centeno dives into the research behind knee stem cell therapy. Do we know that these treatments work?

regenexx.com

"One of the areas where journalists fail is understanding that innovative care using FDA compliant therapies that are being ethically performed and offered, differ drastically from the wild west of stem cells and exosomes. In fact, a group of academics and private practitioners just finished a Delphi panel that was able to make distinctions between these two. The focus was on a legitimate stem cell therapy for knees, namely bone marrow concentrate and not the bait and switch offerings that so many clinics use with fake umbilical cord and exosome therapies. Those Delphi panel results should get published this year, so maybe then journalists will begin learning how to separate the wheat from the chaff."

 

[lobelsteve]

First treatment for pain using human stem cells a success

Researchers have used human stem cells to make pain-killing neurons that provide lasting relief in mice, without side effects, in a single treatment. The next step is to perform extensive safety tests in rodents and pigs, and then move to human patients suffering chronic pain within the next...

www.sciencedaily.com

Moving beyond dead baby dust and scams.

 

[drusso]

First treatment for pain using human stem cells a success

Researchers have used human stem cells to make pain-killing neurons that provide lasting relief in mice, without side effects, in a single treatment. The next step is to perform extensive safety tests in rodents and pigs, and then move to human patients suffering chronic pain within the next...

www.sciencedaily.com

Moving beyond dead baby dust and scams.

http://downloads.hindawi.com/journals/sci/2020/5962354.pdf

Research Article | Open Access
Volume 2020 |Article ID 5962354 | 10 pages | A Randomized Controlled Trial of the Treatment of Rotator Cuff Tears with Bone Marrow Concentrate and Platelet Products Compared to Exercise Therapy: A Midterm Analysis
A Randomized Controlled Trial of the Treatment of Rotator Cuff Tears with Bone Marrow Concentrate and Platelet Products Compared to Exercise Therapy: A Midterm Analysis
Christopher Centeno,1,2 Zachary Fausel,1 Ian Stemper,2 Ugochi Azuike,1 and Ehren Dodson2


Academic Editor: Arianna B. Lovati
Received27 Aug 2019
Revised19 Dec 2019
Accepted26 Dec 2019
Published30 Jan 2020
Abstract
Injectable regenerative therapies such as bone marrow concentrate (BMC) and platelet-rich plasma (PRP) may represent a safe alternative in the treatment of rotator cuff tears. This is a midterm review of a randomized, crossover trial comparing autologous BMC and platelet product injections versus exercise therapy in the treatment of partial and full-thickness supraspinatus tears. Patients enrolled into the study were between 18 and 65 years of age presenting to an outpatient orthopedic clinic with partial to full thickness, nonretracted supraspinatus tendon tears. Enrolled patients were randomized to either ultrasound-guided autologous BMC with PRP and platelet lysate (PL) percutaneous injection treatment or exercise therapy. Patients could cross over to BMC treatment after at least 3 months of exercise therapy. Patients completed the Disability of the Arm, Shoulder and Hand (DASH) scores as the primary outcome measure. Secondary outcomes included the numeric pain scale (NPS), a modified Single Assessment Numeric Evaluation (SANE), and a blinded MRI review. At this midterm review, results from 25 enrolled patients who have reached at least 12-month follow-up are presented. No serious adverse events were reported. Significant differences were seen in patient reported outcomes for the BMC treatment compared to exercise therapy at 3 and 6 months for pain, and for function and reported improvement (SANE) at 3 months (). Patients reported a mean 89% improvement at 24 months, with sustained functional gains and pain reduction. MRI review showed a size decrease of most tears post-BMC treatment. These findings suggest that ultrasound-guided BMC and platelet product injections are a safe and useful alternative to conservative exercise therapy of torn, nonretracted supraspinatus tendons. This trial is registered with NCT01788683.