scholarly journals Midterm osteolysis-induced aseptic failure of the M6-C™ cervical total disc replacement secondary to polyethylene wear debris

2022 ◽  
Author(s):  
Matthew Scott-Young ◽  
Evelyne Rathbone ◽  
Lauren Grierson
Keyword(s):  
Polyethylene Wear ◽  
Clinical Success ◽  
Total Disc Replacement ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
The Other ◽  
Disc Replacement ◽  
Cervical Disc ◽  
Cervical Total Disc Replacement ◽  
Patient Reported

Abstract Background According to published meta-analyses, cervical total disc replacement (CTDR) seems to be superior to anterior cervical decompression and fusion (ACDF) in most clinical parameters. Despite short-term clinical success of CTDR, there are concerns regarding long-term durability of these prostheses. Methods This prospective study involved 382 patients who received standalone CTDR or a hybrid procedure (ACDF/CTDR). A retrospective comparison between different CTDR devices was conducted regarding patient-reported outcome measures (PROMs), failure scenarios, and revision surgeries. The M6-C™ Artificial Cervical Disc (Orthofix, Lewisville, Texas) cohort was compared to the other CTDR devices clinically. Etiological reasons for revision, and the surgical technique of the revision was investigated. Results Fifty-three patients received M6-C CTDR. Eighteen patients (34%) were revised at an average of 67 months postoperatively for wear-induced osteolysis. There were three additional cases of pending revision. The PROMs of the two groups were similar, indicating that the failure mode (wear-induced osteolysis) is often asymptomatic. The demographics of the two groups were also similar, with more women undergoing revision surgery than men. There were three one-level CTDR, four two-level hybrids, seven three-level hybrids, and three four-level hybrids revised anteriorly. Sixteen patients underwent removal of the prosthesis and were treated according to the extent of osteolysis. There were four vertebrectomies, six revisions to ACDF, and six revisions to another CTDR. One patient underwent supplemental fixation using a posterior approach. The other CTDR cohort had an incidence of 3.3% at the equivalent time, and none of these were due to osteolysis or wear-related events. Conclusions There is a concerning midterm failure rate related to ultra-high-molecular-weight-polyethylene wear-induced osteolysis in the M6-C. Patients implanted with the M6-C prosthesis should be contacted, informed, and clinically and radiologically assessed.

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.

PROMIS correlation with NDI and VAS measurements of physical function and pain in surgical patients with cervical disc herniations and radiculopathy

2019 ◽  
Vol 31 (4) ◽  
pp. 519-524 ◽  
Author(s):  
Robert J. Owen ◽  
Adam Z. Khan ◽  
Steven J. McAnany ◽  
Colleen Peters ◽  
Lukas P. Zebala
Keyword(s):  
Outcome Measures ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Cervical Disc ◽  
Strong Negative Correlation ◽  
Positive Correlation ◽  
Arm Pain ◽  
Pain Scores ◽  
Patient Reported ◽  
Disc Herniations

OBJECTIVEThe aim of this study was to compare the patient-reported outcome measures Neck Disability Index (NDI) and visual analog scale (VAS) with the Patient Reported Outcomes Measurement Information System (PROMIS) physical function (PF) and pain interference (PI) measures, respectively, and to determine their correlations in a surgical population longitudinally.Legacy outcome measures such as NDI and VAS are essential for analyzing treatments in spine surgery for cervical disc herniations with radiculopathy. Despite their usefulness, administrative burdens impose limits on completion of these measures. PROMIS was developed as a patient outcome measure in order to improve reporting of patient symptoms and function and to reduce administrative burden. Despite early positive results of PROMIS in orthopedics, NDI and VAS scores have not been compared with PROMIS scores in patients with cervical disc herniations with radiculopathy.METHODSEighty patients undergoing surgery for cervical disc herniations with radiculopathy were included. All patients were treated at the same tertiary spine center. Patients were seen and PROMIS PF and PI, NDI, and VAS arm and neck pain scores were collected preoperatively and at 1 year postoperatively. Correlations between NDI, VAS, and PROMIS PF and PI were quantified using Pearson correlation coefficients. Two-tailed Student t-tests were used to demonstrate correlation significance, with alpha = 0.05.RESULTSAll 80 (100%) patients completed all preoperative questionnaires. Fifty-seven (72%) and 75 (94%) patients completed all questionnaires at baseline and at the 6-month and 1-year follow-ups, respectively. PROMIS PF and NDI scores demonstrated a strong negative correlation, with Pearson r values of −0.81, −0.77, and −0.75 at baseline, 6 months, and 1 year. PROMIS PI and VAS neck pain scores demonstrated a moderately positive correlation, with Pearson r values of 0.51, 0.61, and 0.6. PROMIS PI and VAS arm pain scores demonstrated a moderately positive correlation, with Pearson r values of 0.46, 0.47, and 0.45.CONCLUSIONSPROMIS PF scores have a strong negative correlation with NDI scores at baseline and in the postoperative course in patients undergoing surgery for cervical disc herniations with radiculopathy. PROMIS PI scores have a moderately positive correlation with VAS neck and arm pain scores at baseline and in the postoperative course. Surgeons may factor these correlation results into the interpretation of patient-reported outcome measures in patients with cervical radiculopathy. Use of PROMIS PF and PI for this patient population may reduce administrative burden while providing reliable outcomes data.

The effectiveness of manipulation of fingers with Dupuytren's contracture 7 days after collagenase clostridial histolyticum injection

2019 ◽  
Vol 45 (3) ◽  
pp. 286-291 ◽  
Author(s):  
Bethany Reynolds ◽  
Vicky Tobin ◽  
Julian A Smith ◽  
Warren M Rozen ◽  
David J. Hunter-Smith
Keyword(s):  
Outcome Measures ◽  
Clinical Success ◽  
Demographic Data ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Extension Deficit ◽  
Level Of Evidence ◽  
Patient Reported ◽  
Collagenase Injection ◽  
Tendon Ruptures

Timing of manipulation of digits after collagenase injection for Dupuytren’s disease varies and often takes place within the first few days post-injection. We prospectively investigated the effectiveness of performing manipulation under local anaesthesia 7 days after injection in 100 patients. Demographic data, passive extension deficit, and patient-reported outcome measures were recorded before collagenase injection. Four to 7 weeks after manipulation, passive extension deficit and patient-reported outcome measures improved significantly without the development of any tendon ruptures. Clinical success was achieved in 41% and clinical improvement in 76% of the patients. Adverse events were reported by 85%. The outcomes were comparable with studies with early manipulation, and demonstrate a safe and effective variation to current protocols. We conclude that delaying manipulation to 7 days after collagenase injection is safe and efficient, which allows for flexibility in clinical appointments without negatively affecting outcome. Level of evidence: III

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)

scholarly journals Different collagenase delivery for Dupuytren disease in public hospitals

2020 ◽  
Vol 3 (2) ◽  
pp. 22-31
Author(s):  
Jessca A Paynter ◽  
Vicky Tobin ◽  
James CS Leong ◽  
Warren Matthew Rozen ◽  
David J Hunter-Smith
Keyword(s):  
Clinical Success ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Public Hospitals ◽  
Dupuytren’S Disease ◽  
Patient Specific ◽  
Extension Deficit ◽  
Dupuytren's Disease ◽  
Number Of Patients ◽  
Patient Reported

Background: The delivery protocol of collagenase Clostridium histolyticum (collagenase) injection for Dupuytren’s disease is variable, due to limited evidence for any one approach and widespread ‘off-label’ delivery occurring in Australia. As such, this preliminary study aimed to assess whether different collagenase delivery protocols for treating Dupuytren’s disease have an impact on effectiveness and safety. It was hypothesised that different collagenase delivery would affect outcomes. Methods: This preliminary, prospective study included a consecutive cohort of adult patients with Dupuytren’s disease being treated with collagenase within two Australian public hospitals to determine whether different collagenase delivery protocols impact on effectiveness and safety. The therapeutic effect was measured objectively using the total passive extension deficit (TPED), clinical success and clinical improvement. Three patient-reported outcome measures (PROMs) were used: Unité Rhumatologique des Affections de la Main (URAM), the Southampton Dupuytren’s Scoring Scheme and the Canadian Occupational Patient-Specific Functional Scale (PSFS). Results: The delivery of collagenase was variable at both clinics. The number of patients treated with collagenase at Institute I and Institute II was 49 and 18, respectively. Clinical success was achieved in 42 per cent of the Institute I and 35 per cent of the Institute II cohort. A statistically significant reduction in all three PROMs was observed for both cohorts. No significant differences between effectiveness or safety was found when comparing the two cohorts. Conclusion: The delivery of collagenase was variable at Institutes I and II, but these differences did not appear to impact the effectiveness or safety of collagenase delivery.

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