Early Implant Failure of a 2-Level M6-Cervical Total Disc Replacement

Clark, Nicholas J.; Francois, Elvis L.; Freedman, Brett A.; Currier, Bradford L.

doi:10.2106/jbjs.cc.19.00644

Cited by 11 publications

(17 citation statements)

References 27 publications

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“…However, in several studies in the present review, the early onset of bone resorption led authors to conclude that wear debris was an unlikely primary cause [39,41,44,45,53]. In late onset cases, progressive osteolysis was attributed to mechanical failure of the M6-C in five studies, despite findings consistent with device failure and histopathology confirming the presence of particulate polymeric debris and giant cells [29,30,33,35,36]. This device was noted to include a sheath intended to contain and decrease debris migration, and rupture of the sheath contributed to particle-induced osteolysis [35,36].…”

Section: Wear Debrismentioning

confidence: 68%

“…Duration of implantation prior to reoperation ranged from 15-96 months. Radiographic analysis was performed at multiple time points, with progressive osteolysis observed in eight articles [26][27][28][29][30][31][32]. In twelve articles, the implants were removed.…”

Section: Reported Osteolysismentioning

confidence: 99%

“…In eight articles, histological analysis was reported to confirm the radiographic and/or intra-operative diagnosis of osteolysis [29-33, 35, 36]. Two articles reported positive cultures for Propionibacterium acnes [29,30] and two for Staphylococcus epidermidis. [35,36] Some of the observations included abundant giant cells, granulomatous formation, macrophages, metal particles, and flakes of polymeric debris, which are features of a potentially osteolysis-inducing foreign body response [23].…”

Section: Reported Osteolysismentioning

confidence: 99%

“…Neck pain was most frequently reported for patients with osteolysis [26,27,30,[33][34][35][36][37][38]. Radicular symptoms were reported in four studies [28,33,35,38] and paresthesia was reported in three case reports [29,30,33]. Other symptoms accompanying osteolysis were: dysphagia, respiratory compromise, myelopathy, shoulder pain, distal upper extremity numbness, and decreased fine motor dexterity.…”

Section: Reported Osteolysismentioning

confidence: 99%

“…Cultures tested positive for either for Propionibacterium acnes or Staphylococcus epidermidis; however, there were reports of some negative cultures or normal inflammatory markers in these cases. Due to this inconsistency, most articles could not conclude that infection was the primary cause [26,29,36].…”

Section: Infection and Metal Hypersensitivitymentioning

confidence: 99%

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The lexicon for periprosthetic bone loss versus osteolysis after cervical disc arthroplasty: a systematic review

et al. 2022

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Background Periprosthetic bone loss is a common observation following arthroplasty. Recognizing and understanding the nature of bone loss is vital as it determines the subsequent performance of the device and the overall outcome. Despite its significance, the term “bone loss” is often misused to describe inflammatory osteolysis, a complication with vastly different clinical outcomes and treatment plans. Therefore, the goal of this review was to report major findings related to vertebral radiographic bone changes around cervical disc replacements, mitigate discrepancies in clinical reports by introducing uniform terminology to the field, and establish a precedence that can be used to identify the important nuances between these distinct complications. Methods A systematic review of the literature was conducted following PRISMA guidelines, using the keywords “cervical,” “disc replacement,” “osteolysis,” “bone loss,” “radiograph,” and “complications.” A total of 23 articles met the inclusion criteria with the majority being retrospective or case reports. Results Fourteen studies reported periprosthetic osteolysis in a total of 46 patients with onset ranging from 15–96 months after the index procedure. Reported causes included: metal hypersensitivity, infection, mechanical failure, and wear debris. Osteolysis was generally progressive and led to reoperation. Nine articles reported non-inflammatory bone loss in 527 patients (52.5%), typically within 3–6 months following implantation. The reported causes included: micromotion, stress shielding, and interrupted blood supply. With one exception, bone loss was reported to be non-progressive and had no effect on clinical outcome measures. Conclusions Non-progressive, early onset bone loss is a common finding after CDA and typically does not affect the reported short-term pain scores or lead to early revision. By contrast, osteolysis was less common, presenting more than a year post-operative and often accompanied by additional complications, leading to revision surgery. A greater understanding of the clinical significance is limited by the lack of long-term studies, inconsistent terminology, and infrequent use of histology and explant analyses. Uniform reporting and adoption of consistent terminology can mitigate some of these limitations. Executing these actionable items is critical to assess device performance and the risk of revision. Level of Evidence IV Diagnostic: individual cross-sectional studies with consistently applied reference standard and blinding.

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Section: Wear Debrismentioning

confidence: 68%

Section: Reported Osteolysismentioning

confidence: 99%

Section: Reported Osteolysismentioning

confidence: 99%

Section: Reported Osteolysismentioning

confidence: 99%

Section: Infection and Metal Hypersensitivitymentioning

confidence: 99%

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The lexicon for periprosthetic bone loss versus osteolysis after cervical disc arthroplasty: a systematic review

et al. 2022

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Observations of bony ongrowth and clinical fixation in two retrieved disc replacements

et al. 2023

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Total disc replacements utilize textured coatings to maximize bony ongrowth. However, the contribution of direct bony attachment to overall fixation for total disc replacements has not been reported. The goal of the present study was to document the extent of bony attachment to the surfaces of two clinically functional total disc replacements that were securely fixed at the time of revision. Two metal‐and‐polymeric disc replacements, one cervical and one lumbar, were evaluated following surgical retrieval. The cervical device was retrieved at 8 months and the lumbar device at 28 months post‐operative. Both devices were reported well‐fixed at the time of removal, with large bone masses attached to one endplate of each device. Visual inspections, non‐destructive gravimetric measurements, and surface metrology were performed to assess fixation. These inspections suggested that both devices had been fixed at the time of removal with little in vivo mechanical damage, as surgical extraction damage was noted on both devices and provided imaging showed a lack of device migration. Devices were then embedded and sectioned to evaluate the bone‐implant interface. High resolution photographs and contact microradiographs were taken to assess bony attachment. In contrast to initial analysis, these images revealed radiolucent gaps between the endplates and bone masses. Little direct contact between the bone and endplate surface was identified and the original surgical cuts were still visible. Both devices were clinically fixed at the time of removal and neither had complications associated with loosening. However, osseointegration was minimal in one of the devices and altogether absent from the other. The findings of the present study suggest that other factors may influence overall clinical fixation such as the surgical preparation of the vertebral bone or the surface roughness of the treated endplates. Despite the limitations of the present study, this information is unique to the current total disc replacement literature and the ongrowth and fixation of devices should be considered as a topic for future investigation.

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

2022

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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.

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Early Implant Failure of a 2-Level M6-Cervical Total Disc Replacement

Cited by 11 publications

References 27 publications

The lexicon for periprosthetic bone loss versus osteolysis after cervical disc arthroplasty: a systematic review

The lexicon for periprosthetic bone loss versus osteolysis after cervical disc arthroplasty: a systematic review

Observations of bony ongrowth and clinical fixation in two retrieved disc replacements

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

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