scholarly journals Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial

2016 ◽  
Vol 25 (2) ◽  
pp. 213-224 ◽  
Author(s):  
Kris Radcliff ◽  
Domagoj Coric ◽  
Todd Albert
Keyword(s):  
Clinical Trial ◽  
Outcome Measures ◽  
Total Disc Replacement ◽  
Disc Replacement ◽  
Adverse Event Rate ◽  
Cervical Disc ◽  
Long Term Outcome ◽  
Cervical Total Disc Replacement ◽  
Investigational Device Exemption ◽  
Disease Specific

OBJECTIVE The purpose of this study was to report the outcome of a study of 2-level cervical total disc replacement (Mobi-C) versus anterior cervical discectomy and fusion (ACDF). Although the long-term outcome of single-level disc replacement has been extensively described, there have not been previous reports of the 5-year outcome of 2-level cervical disc replacement. METHODS This study reports the 5-year results of a prospective, randomized US FDA investigational device exemption (IDE) study conducted at 24 centers in patients with 2-level, contiguous, cervical spondylosis. Clinical outcomes at up to 60 months were evaluated, including validated outcome measures, incidence of reoperation, and adverse events. The complete study data and methodology were critically reviewed by 3 independent surgeon authors without affiliation with the IDE study or financial or institutional bias toward the study sponsor. RESULTS A total of 225 patients received the Mobi-C cervical total disc replacement device and 105 patients received ACDF. The Mobi-C and ACDF follow-up rates were 90.7% and 86.7%, respectively (p = 0.39), at 60 months. There was significant improvement in all outcome scores relative to baseline at all time points. The Mobi-C patients had significantly more improvement than ACDF patients in terms of Neck Disability Index score, SF-12 Physical Component Summary, and overall satisfaction with treatment at 60 months. The reoperation rate was significantly lower with Mobi-C (4%) versus ACDF (16%). There were no significant differences in the adverse event rate between groups. CONCLUSIONS Both cervical total disc replacement and ACDF significantly improved general and disease-specific measures compared with baseline. However, there was significantly greater improvement in general and disease-specific outcome measures and a lower rate of reoperation in the 2-level disc replacement patients versus ACDF control patients. Clinical trial registration no. NCT00389597 (clinicaltrials.gov)

The Feasibility of Optimal Surgical Result Prediction according to the Centre of Rotation Shift after Multilevel Cervical Total Disc Replacement

2018 ◽  
Vol 1 (2) ◽  
pp. 6
Author(s):  
Jun Ho Lee
Keyword(s):  
Rating Scale ◽  
Clinical Success ◽  
Total Disc Replacement ◽  
Numeric Rating Scale ◽  
Disc Replacement ◽  
Cervical Disc ◽  
Consecutive Series ◽  
Cervical Total Disc Replacement ◽  
Successful Group ◽  
Centre Of Rotation

Objective: This study investigates the relation between shifted locations of centre of rotation (COR) at each cervical level and subsequent surgical outcomes after multilevel cervical total disc replacement (MCTDR) and identifies radiological parameter that corresponded to change of COR after MCTDR. Methods: The study included a consecutive series of 24 patients who were treated with MCTDR following diagnosis of multilevel cervical disc herniation or stenosis. Numeric rating scale (NRS), range of motion (ROM) at both C2-7 segment and TDR implanted levels, and the location of COR at TDR implanted level were evaluated at pre- and post-MCTDR. These parameters were compared between patients who experienced successful and unsuccessful pain relief.Results: The inherent CORs relatively at ventro-cranial coordinates have demonstrated significant migrations to dorso-caudal locations at each cervical levels, more prominent shifts for the successful group, after MCTDR switch. The unsuccessful group showed markedly reduced C2-7 ROM and reduced angular improvement at C2-7 as well as MCTDR level after surgery in comparison with the successful group. Postoperative C2-7 ROM was related to postoperative COR along the X-axis.Conclusions: The crucial determinants for clinical success after MCTDR, other than mere preservation of the ROM both at C2-7 and TDR implanted levels, was the restoration of COR from ventro-cranial location at degenerated cervical motion segment close to normal coordinates by posterior and inferior shifts after MCTDR. The position of COR along the X-axis after MCTDR was an important factor to determine maintenance of C2-7 RO.

scholarly journals The Feasibility of Optimal Surgical Result Prediction according to the Center of Rotation Shift after Multilevel Cervical Total Disc Replacement

2020 ◽  
Vol 14 (4) ◽  
pp. 445-452
Author(s):  
Jung Hwan Lee ◽  
Jun Ho Lee
Keyword(s):  
Rating Scale ◽  
Clinical Success ◽  
Total Disc Replacement ◽  
Numeric Rating Scale ◽  
Disc Replacement ◽  
Cervical Disc ◽  
Center Of Rotation ◽  
Cervical Total Disc Replacement ◽  
Successful Group ◽  
Cervical Kinematics

Study Design: Retrospective design/spine clinic and tertiary referral hospital.Purpose: This study investigated the association between shifted location of center of rotation (COR) and subsequent surgical outcomes and identified radiological parameters that corresponded to COR change after multilevel cervical total disc replacement (MCTDR).Overview of Literature: Cervical total disc replacement (TDR) maintains normal cervical kinematics after surgery. However, there is a paucity of literature analyzing the relationship between radiological shifts of COR and subsequent clinical success, especially when it comes to the issue of MCTDR switch.Methods: This study included 24 consecutive patients treated with MCTDR following the diagnosis of multilevel cervical disc herniation or stenosis. Numeric rating scale, range of motion (ROM) at both C2–7 segment and TDR implanted levels, and location of COR at TDR level were evaluated pre- and post-MCTDR. These parameters were compared between patients who experienced successful and unsuccessful pain relief.Results: The inherent CORs relatively at ventrocranial coordinates demonstrated significant migrations to dorsocaudal location, more prominent shifts for the successful group, after MCTDR switch. The unsuccessful group showed markedly reduced C2–7 ROM and reduced angular improvement at C2–7 segment and MCTDR level compared with the successful group. Postoperative C2–7 ROM was related to postoperative COR along the x-axis.Conclusions: Aside from ROM preservation at both C2–7 and TDR levels, COR restoration from ventrocranial location close to normal coordinates by posterior and inferior shifts was marked as a clinical success after MCTDR. The COR position along the x-axis after MCTDR was an important factor to determine maintenance of C2–7 ROM.

scholarly journals Subsequent surgery rates after cervical total disc replacement using a Mobi-C Cervical Disc Prosthesis versus anterior cervical discectomy and fusion: a prospective randomized clinical trial with 5-year follow-up

2016 ◽  
Vol 24 (5) ◽  
pp. 734-745 ◽  
Author(s):  
Robert J. Jackson ◽  
Reginald J. Davis ◽  
Gregory A. Hoffman ◽  
Hyun W. Bae ◽  
Michael S. Hisey ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Degenerative Disc Disease ◽  
Surgical Intervention ◽  
Total Disc Replacement ◽  
Anterior Cervical Discectomy ◽  
Disc Replacement ◽  
Disc Disease ◽  
Cervical Total Disc Replacement ◽  
Cervical Discectomy ◽  
Surgery Rates

OBJECTIVE Cervical total disc replacement (TDR) has been shown in a number of prospective clinical studies to be a viable treatment alternative to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic degenerative disc disease. In addition to preserving motion, evidence suggests that cervical TDR may result in a lower incidence of subsequent surgical intervention than treatment with fusion. The goal of this study was to evaluate subsequent surgery rates up to 5 years in patients treated with TDR or ACDF at 1 or 2 contiguous levels between C-3 and C-7. METHODS This was a prospective, multicenter, randomized, unblinded clinical trial. Patients with symptomatic degenerative disc disease were enrolled to receive 1- or 2-level treatment with either TDR as the investigational device or ACDF as the control treatment. There were 260 patients in the 1-level study (179 TDR and 81 ACDF patients) and 339 patients in the 2-level study (234 TDR and 105 ACDF patients). RESULTS At 5 years, the occurrence of subsequent surgical intervention was significantly higher among ACDF patients for 1-level (TDR, 4.5% [8/179]; ACDF, 17.3% [14/81]; p = 0.0012) and 2-level (TDR, 7.3% [17/234]; ACDF, 21.0% [22/105], p = 0.0007) treatment. The TDR group demonstrated significantly fewer index- and adjacent-level subsequent surgeries in both the 1- and 2-level cohorts. CONCLUSIONS Five-year results showed treatment with cervical TDR to result in a significantly lower rate of subsequent surgical intervention than treatment with ACDF for both 1 and 2 levels of treatment. Clinical trial registration no.: NCT00389597 (clinicaltrials.gov)

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