What's the best surgical treatment for patients with cervical radiculopathy due to single-level degenerative disease? A randomized controlled trial

Roland D Donk, André L M Verbeek, Wim I M Verhagen, Hans Groenewoud, Allard J F Hosman, Ronald H M A Bartels, Roland D Donk, André L M Verbeek, Wim I M Verhagen, Hans Groenewoud, Allard J F Hosman, Ronald H M A Bartels

Abstract

Background: To investigate the efficacy of adding supplemental fusion or arthroplasty after cervical anterior discectomy for symptomatic mono-level cervical degenerative disease (radiculopathy), which has not been substantiated in controlled trials until now.

Methods: A randomized controlled trial is reported with 9 years follow up comparing anterior cervical anterior discectomy without fusion, with fusion by cage standalone, or with disc prosthesis. Patients suffering from symptomatic cervical disk degeneration at one level referred to spinal sections of department of neurosurgery or orthopedic surgery of a large general hospital with educational facilities were eligible. Neck Disability Index (NDI), McGill Pain Questionnaire Dutch language version (MPQ-DLV), physical-component summary (PCS), and mental-component summary (MCS) of the 36-item Short-Form Health Survey (SF-36), and re operation rate were evaluated.

Findings: 142 patients between 18 and 55 years were allocated. The median follow-up was 8.9±1.9 years (5.6 to 12.2 years). The response rate at last follow-up was 98.5%. NDI at the last follow-up did not differ between the three treatment groups, nor did the secondary outcomes as MPQ-DLV and PCS or MCS from SF-36. The major improvement occurred within the first 6 weeks after surgery. Afterward, it remained stable. Eleven patients underwent surgery for recurrent symptoms and signs due to nerve root compression at the index or adjacent level.

Conclusions: This randomized trial could not detect a difference between three surgical modalities for treating a single-level degenerative disk disease. Anterior cervical discectomy without implant seems to be similar to anterior cervical discectomy with fusion by cage stand-alone or with disk prosthesis. Due to the small study sample size, this statement should be considered as inconclusive so far.

Trial registration: ISRCTN41681847.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1. Flow diagram according to Consort.
Fig 1. Flow diagram according to Consort.
Fig 2. NDI with 95%CI at different…
Fig 2. NDI with 95%CI at different follow-up moments for the complete sample.
Fig 3. NDI with 95% CI at…
Fig 3. NDI with 95% CI at each follow-up moment and per treatment modality.
Fig 4. Graph depicting PCS (A) and…
Fig 4. Graph depicting PCS (A) and MCS (B) with 95% CIs at different follow up and for each treatment.
Fig 5. VAS at the moment of…
Fig 5. VAS at the moment of completing questionnaire with 95% CI at different follow-up moments until 5 years.

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