Reoperations: ACDF vs TDR

[101N]

---

Members don't see this ad.

Five-Year Reoperation Rates, Cervical Total Disc Replacement Versus Fusion, Results of a Prospective Randomized Clinical Trial
Delamarter, Rick B. MD; Zigler, Jack MD

Spine . 38(9):711–717, 20 April 2013.
doi: 10.1097/BRS.0b013e3182797592

Abstract

Study Design. Prospective randomized clinical trial.

Objective. Determine the reasons for, and rates of, secondary surgical intervention up to 5 years at both the index and adjacent levels in patients treated with cervical total disc replacement (TDR) or anterior cervical discectomy and fusion (ACDF). Patients undergoing TDR received ProDisc-C.

Summary of Background Data. Several outcome-based prospective, randomized clinical trials have shown cervical TDR to be equivalent, if not superior, to fusion. The ability of TDR to allow decompression while maintaining motion has led many to suggest that adjacent-level degeneration and reoperation rates may be decreased when compared with fusion.

Methods. A total of 209 patients were treated and randomized (TDR, n = 103; ACDF, n = 106) at 13 sites. A secondary surgical intervention at any level was considered a reoperation.

Results. At 5 years, patients who received ProDisc-C had statistically significant higher probability of no secondary surgery at the index and adjacent levels than patients who underwent ACDF (97.1% vs. 85.5%, P = 0.0079). No reoperations in patients who received ProDisc-C were performed for implant breakages or device failures. For patients who underwent ACDF, the most common reason for reoperation at the index level was pseudarthrosis, and for patients who underwent both ACDF and TDR, the most common reason for adjacent-level surgery was recurrent neck and/or arm pain.

Conclusion. Five-year follow-up of a prospective randomized clinical trial revealed 5-fold difference in reoperation rates when comparing patients who underwent ACDF (14.5%) with patients who underwent TDR (2.9%). These findings suggest the durability of TDR and its potential to slow the rate of adjacent-level disease.

Level of Evidence: 1

< Previous Article | Next Article >

 

[lobelsteve]

209 patients at 13 centers.

How long was recruiting period?
What are the financial ties of authors and docs at other 11 centers.

14% reop rate seems higher than baseline.

 

[Ducttape]

209 patients at 13 centers.

How long was recruiting period?
What are the financial ties of authors and docs at other 11 centers.

14% reop rate seems higher than baseline.

it would be rather difficult to make this a blinded study...


Doc to patient: "hmm. still have pain. well, you had Pro-Disc C, so we cant reoperate, sorry. Now if you had just an ACDF, maybe we could do something"

Doc documentation: "No reoperation recommended for this patient"

Study conclusion: No reoperation for patients with Pro-DiscC

 

[painstop]

Financial disclosures are key...after that Medtronic bone graft mess I don't think spine surgeons are at the top of the list of physicians who can be trusted to provide truly objective clinical data without any monetary incentive

 

[lobelsteve]

it would be rather difficult to make this a blinded study...


Doc to patient: "hmm. still have pain. well, you had Pro-Disc C, so we cant reoperate, sorry. Now if you had just an ACDF, maybe we could do something"

Doc documentation: "No reoperation recommended for this patient"

Study conclusion: No reoperation for patients with Pro-DiscC

I said nothing about blinding. Recruitment: look at Kalmes study for vertebroplasty. THey took a few years longer than they would have liked to get their numbers to try and show power of the study. I suspect finding 200 patients for ACDF would not take long for 13 centers. Would like inclusion/exclusion criteria to determine what is up.

 

[DrMattOglesby]

I think it is also important to note that we don't truly know the long-term effects of the implants used in TDRs.
For all we know, there exists a possibility that these biomaterials could suffer a similar fate to those of hip replacements. However, the ramifications could be more dire due to the close proximity with the spinal cord. So even if TDRs are presumably more durable, future studies need to have larger samples with longer follow-up periods to determine the safety of TDR devices.