Unintended fusion in cervical artificial disk replacement: a prospective study on heterotopic ossification, progression, and clinical outcome, with 5-year follow-up

Marques, Catarina; MacDowall, Anna; Skeppholm, Martin; Moreira, Nuno Canto; Olerud, Claes

doi:10.1007/s00586-021-06722-6

Cited by 4 publications

(6 citation statements)

References 25 publications

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“…However, spontaneous fusion occurred in 27% of ADR implants at 5 years of follow-up. 28 In our study with 10 years of follow-up, 34% of the ADR implants had unintended fusion. Spontaneous fusion tends to occur within the first 5 years after surgery, and then the process seems to slow down.…”

Section: Table 3 Pp Analysis Of Baselinementioning

confidence: 51%

Artificial disc replacement and adjacent-segment pathology: 10-year outcomes of a randomized trial

Kontakis

Marques

Löfgren

et al. 2022

Journal of Neurosurgery: Spine

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OBJECTIVE Artificial disc replacement (ADR) is designed to preserve motion and thus protect against adjacent-segment pathology (ASP) and act as an alternative treatment to fusion surgery. The question remains, how well do ADR devices perform after 10 years of follow-up compared with fusion surgery in terms of patient satisfaction, sustainability, and protection against ASP? METHODS This was the 10-year follow-up study of 153 participants who underwent ADR or fusion surgery after anterior decompression due to cervical degenerative radiculopathy (ISRCTN registration no. 44347115). Scores on the Neck Disability Index (NDI), EQ-5D, and visual analog scale for neck and arm pain were obtained from the Swedish Spine Registry and analyzed using ANCOVA. Information about secondary surgical procedures was collected from medical records and presented as Kaplan-Meier curves. MRI and flexion-extension radiography were performed, and ASP was graded according to the Miyazaki classification system. RESULTS Ten participants were lost to follow-up, which left 143 participants (80 underwent ADR and 65 underwent anterior cervical discectomy and fusion). There were no differences between groups in terms of patient-reported outcome measures (10-year difference in NDI scores 1.7 points, 95% CI −5.1 to 8.5, p = 0.61). Nineteen (24%) participants in the ADR group compared with 9 (14%) in the fusion group underwent secondary surgical procedures. The higher reoperation rate of the ADR group was mainly due to 11 female participants with device loosening. The rates of reoperation due to ASP were similar between groups, which was confirmed with MRI assessment of ASP that also showed no differences between the groups (p = 0.21). CONCLUSIONS This was the first 10-year follow-up study to compare ADR with fusion surgery and to provide MRI information for the assessment of ASP. The authors found no benefit of ADR over fusion surgery after anterior decompression for cervical degenerative radiculopathy.

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Section: Table 3 Pp Analysis Of Baselinementioning

confidence: 51%

Artificial disc replacement and adjacent-segment pathology: 10-year outcomes of a randomized trial

Kontakis

Marques

Löfgren

et al. 2022

Journal of Neurosurgery: Spine

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“…Male sex is widely recognized as an unfavourable predictor of HO formation after various surgeries such as arthroplasty, 41,42 cervical disc replacement, 43 oncological prostheses implantation, 44 and operations for different trauma, including proximal humerus 45 and acetabulum. 46 In this study, we found that male sex had an adjusted odds ratio (OR) value of 1.64 (95% CI 1.04 to 2.56) compared to female in elbow trauma, which reflects the findings of Cirino et al 45 in proximal humeral fractures (OR 3.57 (95% CI 1.30 to 9.80)).…”

Section: Discussionmentioning

confidence: 99%

A new prognostic nomogram for heterotopic ossification formation after elbow trauma

Sun

Liu

et al. 2022

The Bone & Joint Journal

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Aims Heterotopic ossification (HO) is a common complication after elbow trauma and can cause severe upper limb disability. Although multiple prognostic factors have been reported to be associated with the development of post-traumatic HO, no model has yet been able to combine these predictors more succinctly to convey prognostic information and medical measures to patients. Therefore, this study aimed to identify prognostic factors leading to the formation of HO after surgery for elbow trauma, and to establish and validate a nomogram to predict the probability of HO formation in such particular injuries. Methods This multicentre case-control study comprised 200 patients with post-traumatic elbow HO and 229 patients who had elbow trauma but without HO formation between July 2019 and December 2020. Features possibly associated with HO formation were obtained. The least absolute shrinkage and selection operator regression model was used to optimize feature selection. Multivariable logistic regression analysis was applied to build the new nomogram: the Shanghai post-Traumatic Elbow Heterotopic Ossification Prediction model (STEHOP). STEHOP was validated by concordance index (C-index) and calibration plot. Internal validation was conducted using bootstrapping validation. Results Male sex, obesity, open wound, dislocations, late definitive surgical treatment, and lack of use of non-steroidal anti-inflammatory drugs were identified as adverse predictors and incorporated to construct the STEHOP model. It displayed good discrimination with a C-index of 0.80 (95% confidence interval 0.75 to 0.84). A high C-index value of 0.77 could still be reached in the internal validation. The calibration plot showed good agreement between nomogram prediction and observed outcomes. Conclusion The newly developed STEHOP model is a valid and convenient instrument to predict HO formation after surgery for elbow trauma. It could assist clinicians in counselling patients regarding treatment expectations and therapeutic choices. Cite this article: Bone Joint J 2022;104-B(8):963–971.

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“…5). Evidence suggests that HO formation does not compromise patient-reported outcomes [31,32] but radiological studies are lacking. The loss of motion-preservation may lead to increased rates of ASD, as reported with ACDF.…”

Section: Heterotopic Ossification and Fusion After Cervical Disc Tota...mentioning

confidence: 99%

Heterotopic ossification, osteolysis and implant failure following cervical total disc replacement with the M6-C™ artificial disc

Häckel,

Gaff,

Pabbruwe

et al. 2024

Eur Spine J

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Introduction A recent study reported a 34% mid-term revision rate after M6-C™ cervical total disc replacement (CTDR) for wear-related osteolysis. Here, we aim to investigate the prevalence, risk factors, and radiographic characteristics of periprosthetic bony changes and implant failure of the M6-C™ artificial disc. Methods We retrospectively analysed radiographic (conventional X-ray, CT scan) and clinical outcomes (EQ-5D-5L, Neck Disability Index (NDI), and Visual Analog Scale (VAS) for neck and arm pain) data collected during routine follow-up of patients who underwent CTDR with the M6-C™ between 2011 and 2015. Results In total, 85 patients underwent CTDR with the M6-C™. Follow-up data were available for 43 patients (54% female, mean age 44 years) with 50 implants and a mean follow-up of 8.1 years (6.5–11 years). Implant failure with the presence of severe osteolysis was identified in 5 (12%) patients who were all male (p = 0.016) and implanted at the C5/6 level (p = 0.11). All failed implants required revision surgery. The overall prevalence of osteolysis was 44% (22/50 implants) and 34% (17/50 implants) for significant heterotopic ossification. Patients with high-grade osteolysis showed higher VAS arm pain (p = 0.05) and lower EQ-5D-VAS health VAS (p = 0.03). Conclusion We report a lower reoperation rate for failed M6-C™ implants than previously published, but confirmed that osteolysis and heterotopic ossification are common following CTDR with the M6-C™ and may be asymptomatic. Therefore, we strongly recommend ongoing clinical and radiographic monitoring after CTDR with the M6-C™, particularly for male patients implanted at the C5/6 level.

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Unintended fusion in cervical artificial disk replacement: a prospective study on heterotopic ossification, progression, and clinical outcome, with 5-year follow-up

Cited by 4 publications

References 25 publications

Artificial disc replacement and adjacent-segment pathology: 10-year outcomes of a randomized trial

Artificial disc replacement and adjacent-segment pathology: 10-year outcomes of a randomized trial

A new prognostic nomogram for heterotopic ossification formation after elbow trauma

Heterotopic ossification, osteolysis and implant failure following cervical total disc replacement with the M6-C™ artificial disc

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