A Prospective, Randomized, Controlled Clinical Investigation Comparing PCM Cervical Disc Arthroplasty With Anterior Cervical Discectomy and Fusion

Phillips, Frank M.; Lee, Joe Y B; Geisler, Fred H.; Cappuccino, Andrew; Chaput, Christopher D.; DeVine, John G.; Reah, Christopher J.; Gilder, Kye; Howell, Kelli; McAfee, Paul C.

doi:10.1097/brs.0b013e318296232f

Cited by 177 publications

(106 citation statements)

References 47 publications

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“…Fusion rates of ACDF with cervical plating have been estimated to be 97.1% for single-level procedures 33. Comparatively, randomized control clinical trials involving patients treated with ACDF with anterior plating and allograft bone had fusion rates of 89% to 96.6% at 24 months 34–38…”

Section: Discussionmentioning

confidence: 99%

The ROI-C zero-profile anchored spacer for anterior cervical discectomy and fusion: biomechanical profile and clinical outcomes

Bucci

Cowan³

et al. 2017

MDER

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IntroductionAnterior cervical discectomy and fusion (ACDF) has been the gold standard for treating cervical degenerative disc disease (cDDD). The use of anterior plates in ACDF poses an increased risk of complications such as screw or plate dislodgement, soft tissue injury, esophagus perforation, and dysphagia. The ROI-C™ implant system consists of a zero-profile interbody fusion cage with self-locking plates designed for stand-alone fusion without external plates or screws.ObjectiveThe purpose of this report is to describe the ROI-C™ implant system with VerteBRIDGE™ anchor plates, including indications for use, surgical technique, preclinical testing, and clinical study results. The objectives of the clinical study were to assess fusion status, incidence of dysphagia and other device-related complications, and patient reported outcomes.MethodsThis was a retrospective, multicenter cohort study of 110 patients who underwent ACDF with ROI-C at seven study centers. Patient charts and radiographs were reviewed for any complications or device malfunction. The final follow-up was conducted prospectively and included collection of neck disability index, and visual analog scale (VAS) neck and arm pain scores.ResultsThe mean operation time was 73 minutes, and mean blood loss was 25 mL (range 0–75 mL). Mean follow-up was 20.7 months (range 9.5–42.2). Dysphagia was reported in two patients (1.8%), and 99.1% of patients achieved fusion. One patient had radiographically confirmed pseudarthrosis at 12 months that was asymptomatic and did not require surgery. One patient had subsequent surgery owing to adjacent level degeneration. The mean neck disability index, VAS neck pain, and VAS right and left arm pain scores at final follow-up were 19, 26.5, 12.5, and 15.3, respectively.ConclusionThe ROI-C interbody cage with VerteBRIDGE anchor plates achieved a high rate of fusion, with a low incidence of dysphagia. These patients had similar or better outcomes compared to ACDF with anterior plating reported in peer-reviewed literature.

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Section: Discussionmentioning

confidence: 99%

The ROI-C zero-profile anchored spacer for anterior cervical discectomy and fusion: biomechanical profile and clinical outcomes

Bucci

Cowan³

et al. 2017

MDER

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“…Several Level I evidence randomized clinical trials have confirmed both the safety and efficacy of TDR in both the short-and long-term. [8][9][10][11][12][13][14] TDR has shown to have many possible advantages over ACDF including lower rates of subsequent surgical intervention, 15,16 lower rates of adjacent segment degeneration, 13,17,18 and an advantage in cost-effectiveness. 19,20 Furthermore, kinematic analyses have shown TDR to maintain functional biomechanics at the level treated while mitigating excess motion at adjacent segments.…”

Section: Introductionmentioning

confidence: 99%

Long-term Evaluation of Cervical Disc Arthroplasty with the Mobi-C© Cervical Disc: A Randomized, Prospective, Multicenter Clinical Trial with Seven-Year Follow-up

et al. 2017

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“…In contrast to the prior IDE studies, Phillips et al reported similar reoperation rates (ACDF 5.4%, ACDA 5.2%) at two-year follow-up with a different implant design. [22]…”

Section: Discussionmentioning

confidence: 99%

Reoperation and complications after anterior cervical discectomy and fusion and cervical disc arthroplasty: a study of 52,395 cases

et al. 2018

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A Prospective, Randomized, Controlled Clinical Investigation Comparing PCM Cervical Disc Arthroplasty With Anterior Cervical Discectomy and Fusion

Cited by 177 publications

References 47 publications

The ROI-C zero-profile anchored spacer for anterior cervical discectomy and fusion: biomechanical profile and clinical outcomes

The ROI-C zero-profile anchored spacer for anterior cervical discectomy and fusion: biomechanical profile and clinical outcomes

Long-term Evaluation of Cervical Disc Arthroplasty with the Mobi-C© Cervical Disc: A Randomized, Prospective, Multicenter Clinical Trial with Seven-Year Follow-up

Reoperation and complications after anterior cervical discectomy and fusion and cervical disc arthroplasty: a study of 52,395 cases

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