Örebro Multicenter Study on Operative Treatment of Cervical Radiculopathy — OMSAP  

Cervical Radiculopathy Clinical Trial

Official title: Örebro Multicenter Study on Operative Treatment of Cervical Radiculopathy: Anterior Cervical Decompression and Fusion Versus Posterior Foraminotomy

Status Recruiting

Clinical Trial Summary

This study compares anterior cervical decompression and fusion (ACDF) to posterior foraminotomy (PF) in surgical treatment for cervical radiculopathy (CR) caused by root canal compression, in a multicenter prospective randomized trial. The investigators hypothesize equal decompression of nerve root, and equal clinical outcome in both treatment groups.

Clinical Trial Description

Both ACDF and PF are effective in surgical treatment of CR. However, the techniques has different complication profiles and carry different costs. No comparative study with high level of evidence has been published, why the basis for clinical guidelines are lacking.

The study consists of 110 patients with CR not responding to non-surgical treatment for 6 weeks and with a Neck Disability Index (NDI) over 30 points/60 %, that are randomized to either technique in a 1:1 ratio and followed for two years.

Primary variable is NDI, secondary variables are Numerical Pain Rating Scale (NRS) separately for arm and neck pain and health related quality of life (EQ-5D). Tertiary variables are complications and reoperations. The patients are also followed radiographically with plain x-rays in extension and flexion, CT, and MRI.

The study has a non-inferiority design with ACDF as active control. A NDI difference of less than 8,5 points/17 % (=minimally clinical important difference, MCID, for NDI) is considered a non-inferior result. A secondary superiority evaluation will also be performed.

Analysis Primarily, patient-related outcome measures will be analyzed in terms of intention to treat (ITT) and include all randomized patients. Missing values will be imputed. The investigators will calculate, by using analysis of covariance (ANCOVA), the mean outcome values for each treatment group, adjusted for baseline values of the outcome. The mean difference between the groups will also be presented.

Secondary outcome analyses using the Student t test, Chi-Square, Mann-Whitney, Fisher exact test.

The tertiary outcome analyses will be based on available cases. The time to revision surgery according to treatment assignment will be analyzed and plotted according to the Kaplan-Meier method, while hazard ratios, with regard to having secondary surgery after ACDF compared to PF, will be estimated by the Cox model with calendar time as the time scale. Men and women will be analyzed separately.

An "Ad Interim" analysis will be performed by a non-partial observer and/or statistician when 40 patients are included, regarding NDI difference, complications and reoperations. ;

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Cervical Root Compression
• Radiculopathy

• NCT number: NCT04177849
• Study type: Interventional
• Source: Region Örebro County
• Contact: Marek Holy, MD
• Phone: +46 0196025323
• Email: marek.holy@regionorebrolan.se
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2020
• Completion date: January 2026