Results of the Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDisc®-L Total Disc Replacement Versus Circumferential Fusion for the Treatment of 1-Level Degenerative Disc Disease

Zigler, Jack E.; Delamarter, Rick B.; Spivak, Jeffrey M.; Linovitz, Raymond; Danielson, Guy O.; Haider, Thomas; Cammisa, Frank P.; Zuchermann, Jim; Balderston, Richard; Kitchel, Scott H.; Foley, Kevin T.; Watkins, Robert G.; Bradford, David S.; Yue, James J.; Yuan, Hansen A.; Herkowitz, Harry N.; Geiger, Doug; Bendo, John A.; Peppers, Timothy; Sachs, Barton L.; Girardi, Federico P.; Kropf, Michael A.; Goldstein, Jeff

doi:10.1097/brs.0b013e318054e377

Cited by 399 publications

(313 citation statements)

References 9 publications

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“…The total improvement of pain in the FDA trials [4,10,27] was larger than in this study and the difference could be the effect of a different case mix in our series.…”

Section: Discussioncontrasting

confidence: 67%

“…Subsequently, three ''IDE'' trials were designed and undertaken comparing different TDR techniques to fusion in order to reach FDA approval in the USA [4,10,27]. Extraction of pedicular screws 0 20 20…”

Section: Discussionmentioning

confidence: 99%

“…These studies were on highly selected cases and without equal randomisation to compare the effect of TDR with fusion. Many studies dealing with TDR [4,10,15,23,26,27] include patients with only one symptomatic level causing pain and dysfunction due to DDD, being discographypositive and without spondylosis or facet joint arthritis, the patients sampled thus representing a subgroup of all patients with painful motion segments. Based on these studies, TDR cannot be recommended for a wide group of patients with degenerative problems.…”

Section: Discussionmentioning

confidence: 99%

“…Follow-up at 1 and 2 years included a question on patient satisfaction with their treatment and a global outcome score of pain: total relief, much better, better, unchanged, or worse [8], which also constituted the primary outcome variable at 2 years. ODI success was described as [25% improvement, as in some FDA studies on TDR [4,10,27]. Complications and reoperations, including patients scheduled for reoperation, were recorded as they occurred.…”

Section: Clinical and Radiographic Outcome Measurementsmentioning

confidence: 99%

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Total disc replacement compared to lumbar fusion: a randomised controlled trial with 2-year follow-up

et al. 2009

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The study design includes a prospective, randomised controlled study comparing total disc replacement (TDR) with posterior fusion. The main objective of this study is to compare TDR with lumbar spinal fusion, in terms of clinical outcome, in patients referred to a spine clinic for surgical evaluation. Fusion is effective for treating chronic low back pain (LBP), but has drawbacks, such as stiffness and possibly adjacent level degradation. Motion-preserving options have emerged, of which TDR is frequently used because of these drawbacks. How the results of TDR compare to fusion, however, is uncertain. One hundred and fifty-two patients with a mean age of 40 years (21-55) were included: 90 were women, and 80 underwent TDR. The patients had not responded to a conservative treatment programme and suffered from predominantly LBP, with varying degrees of leg pain. Diagnosis was based on clinical examination, radiographs, MRI, and in unclear cases, diagnostic injections. Outcome measures were global assessment

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“…The total improvement of pain in the FDA trials [4,10,27] was larger than in this study and the difference could be the effect of a different case mix in our series.…”

Section: Discussioncontrasting

confidence: 67%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Clinical and Radiographic Outcome Measurementsmentioning

confidence: 99%

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Total disc replacement compared to lumbar fusion: a randomised controlled trial with 2-year follow-up

et al. 2009

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“…Although length of hospital stay is often used as an outcome variable, the criteria are not always described in detail or standardized [15]. Other studies use mobilization criteria corresponding to the ones used in the present study requiring the patients to be able to transfer and ambulate before discharge [16]. This corresponds to the criteria used in the assessment of fast-track surgery in hip and knee replacement [17].…”

Section: Discussionmentioning

confidence: 99%

A comprehensive multimodal pain treatment reduces opioid consumption after multilevel spine surgery

et al. 2013

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Purpose Major spine surgery with multilevel instrumentation is followed by large amount of opioid consumption, significant pain and difficult mobilization in a population of predominantly chronic pain patients. This case-control study investigated if a standardized comprehensive pain and postoperative nausea and vomiting (PONV) treatment protocol would improve pain treatment in this population. Methods A new regimen with acetaminophen, NSAIDs, gabapentin, S-ketamine, dexamethasone, ondansetron and epidural local anesthetic infusion or patient controlled analgesia with morphine, was introduced in a post-intervention group of 41 consecutive patients undergoing multilevel (median 10) instrumented spinal fusions and compared with 44 patients in a pre-intervention group. Results Compared to patients in the pre-intervention group, patients treated according to the new protocol consumed less opioid on postoperative day (POD) 1 (P = 0.024) and 2 (P = 0.048), they were mobilized earlier from bed (P = 0.003) and ambulation was earlier both with and without a walking frame (P = 0.027 and P = 0.027, respectively). Finally, patients following the new protocol experienced low intensities of nausea, sedation and dizziness on POD 1-6. Conclusions In this study of patients scheduled for multilevel spine surgery, it was demonstrated that compared to a historic group of patients receiving usual care, a comprehensive and standardized multimodal pain and PONV protocol significantly reduced opioid consumption, improved postoperative mobilization and presented concomitant low levels of nausea, sedation and dizziness.

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Total disc replacement for chronic back pain in the presence of disc degeneration

Jacobs

Gaag

Tuschel

et al. 2012

Cochrane Database of Systematic Reviews

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Results of the Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDisc®-L Total Disc Replacement Versus Circumferential Fusion for the Treatment of 1-Level Degenerative Disc Disease

Abstract: ProDisc-L has been found to be safe and efficacious. In properly chosen patients, ProDisc-L has been shown to be superior to circumferential fusion by multiple clinical criteria.

Cited by 399 publications

References 9 publications

Total disc replacement compared to lumbar fusion: a randomised controlled trial with 2-year follow-up

Total disc replacement compared to lumbar fusion: a randomised controlled trial with 2-year follow-up

A comprehensive multimodal pain treatment reduces opioid consumption after multilevel spine surgery

Total disc replacement for chronic back pain in the presence of disc degeneration

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