ARTIFICIAL DISC VERSUS FUSION A prospective randomised study with 2-year follow-up on 99 patients.

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Presentation transcript:

ARTIFICIAL DISC VERSUS FUSION A prospective randomised study with 2-year follow-up on 99 patients

Study design 115 patients were randomised in a 1:1 ratio to a Bryan artificial disc replacement (56) or an anterior cervical fusion with allograft and a plate (59).

Objective To examine the functional outcome and radiographic results of this trial to determine the role of the Bryan artificial cervical disc replacement for patients with 1-level cervical disc disease.

Background data Artificial cervical disc replacement has become an option for cervical radiculopathy. This study is a pooled data set from 3 centres involved in the U.S. FDA investigational Device Exemption Trial evaluating the Bryan artificial disc.

Methods Inclusion criteria: 1-level cervical disc disease in C3-C7, age > 21, failure of conservative care 6 weeks, NDI > 30%. Exclusion criteria: significant anatomic deformity, previous procedures at the operative level. 12 months follow-up was available for 110 patients and 24 months follow-up complete for 99.

...cont’d Disability and pain were assessed using the Neck Disability Index(NDI) and the Visual Analogue Scale(VAS) of the neck and arm pain. SF-36 outcome measures were obtained including the physical and mental component scores. Range of motion was determined by radiologic assessment of flexion-extension radiographs. Prospective data was collected before surgery and at 6 weeks, 3, 6, 12 and 24 months after surgery.

Results

Complications Control group: 1 patient required posterior cervical fusion for non-union, 1 required revision ACDF for non-union, and 2 required ACDF for adjacent level disease. Bryan group: 2 required ACDF for adjacent level disease.

Conclusions.. The Bryan artificial disc replacement compares favourably to anterior cervical discectomy and fusion for the treatment of patients with 1-level cervical disc disease. At the 2-year follow-up, there are statistically significant differences between the groups with improvement in the NDI, the neck pain and arm pain VAS scores, and the SF-36 physical component score in the Bryan disc population.

..cont’d There were no intra-operative complications, no vascular or neurologic complications, no spontaneous fusions, and no device failures or explantations in the Bryan cohort. The disc replacement group retained an average of 7.9° of flexion-extension at 24 months.

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