A 5- to 8-year randomized study on the treatment of cervical radiculopathy: anterior cervical decompression and fusion plus physiotherapy versus physiotherapy alone

Journal of Neurosurgery: Spine 26(1):19-27

The aim of this study was to evaluate the 5- to 8-year outcome of anterior cervical decompression and fusion (ACDF) combined with a structured physiotherapy program as compared with that following the same physiotherapy program alone in patients with cervical radiculopathy. No previous prospective randomized studies with a follow-up of more than 2 years have compared outcomes of surgical versus nonsurgical intervention for cervical radiculopathy.

METHODS: Fifty-nine patients were randomized to ACDF surgery with postoperative physiotherapy (30 patients) or to structured physiotherapy alone (29 patients). The physiotherapy program included general and specific exercises as well as pain coping strategies. Outcome measures included neck disability (Neck Disability Index [NDI]), neck and arm pain intensity (visual analog scale [VAS]), health state (EQ-5D questionnaire), and a patient global assessment. Patients were followed up for 5–8 years.

RESULTS: After 5–8 years, the NDI was reduced by a mean score% of 21 (95% CI 14–28) in the surgical group and 11% (95% CI 4%–18%) in the nonsurgical group (p = 0.03). Neck pain was reduced by a mean score of 39 mm (95% CI 26–53 mm) compared with 19 mm (95% CI 7–30 mm; p = 0.01), and arm pain was reduced by a mean score of 33 mm (95% CI 18–49 mm) compared with 19 mm (95% CI 7–32 mm; p = 0.1), respectively. The EQ-5D had a mean respective increase of 0.29 (95% CI 0.13–0.45) compared with 0.14 (95% CI 0.01–0.27; p = 0.12). Ninety-three percent of patients in the surgical group rated their symptoms as “better” or “much better” compared with 62% in the nonsurgical group (p = 0.005). Both treatment groups experienced significant improvement over baseline for all outcome measures.

CONCLUSIONS: In this prospective randomized study of 5- to 8-year outcomes of surgical versus nonsurgical treatment in patients with cervical radiculopathy, ACDF combined with physiotherapy reduced neck disability and neck pain more effectively than physiotherapy alone. Self-rating by patients as regards treatment outcome was also superior in the surgery group. No significant differences were seen between the 2 patient groups as regards arm pain and health outcome.

 

Randomized, Controlled, Multicenter, Clinical Trial Comparing BRYAN Cervical Disc Arthroplasty With Anterior Cervical Decompression and Fusion in China

Spine 2012 ; 37 : 433 – 438. DOI: 10.1097/BRS.0b013e31822699fa

Study Design. Prospective, randomized, controlled, multicenter clinical trial.

Objective. To compare outcomes of cervical disc arthroplasty with those of anterior cervical decompression and fusion (ACDF) in a Chinese population.

Summary of Background Data. Cervical disc arthroplasty has been found to be superior to ACDF for maintaining range of motion (ROM) at the index spinal segment and possibly will avoid abnormal stress to adjacent segments.

Methods. A total of 120 patients from 3 large hospitals in China were randomly assigned to treatment with cervical disc arthroplasty (n = 60) using the BRYAN prosthesis or ACDF (n = 60) and were observed postoperatively for 24 months.

Results. The 2 groups had similar preoperative demographics and baseline characteristics including ROM, neck disability index, and visual analogue scale for neck and arm pain. The total disc replacement (TDR) group had a significantly longer operation time than the ACDF group ( P < 0.001). Outcome data obtained after 24 months revealed a significant difference between the groups in mean change from baseline in ROM at the index level ( P < 0.001); ROM was maintained in the TDR group but reduced in the ACDF group. There were no signifi cant between-group differences in the baseline changes in neck disability index or visual analogue scale scores for pain. One patient in the TDR group and 4 patients in the ACDF group required reoperations.

Conclusion. At 24 months after surgery, the cervical disc prosthesis yielded good clinical results while maintaining ROM at the index level. Cervical disc arthroplasty appears to be a viable alternative to ACDF.