Örebro Multicenter Study on Operative Treatment of Cervical Radiculopathy (OMSAP)

  • STATUS
    Recruiting
  • End date
    Jan 5, 2026
  • participants needed
    110
  • sponsor
    Region Örebro County
Updated on 5 June 2022
MRI
arm pain
discectomy
radiculopathy
foraminotomy
cervical radiculopathy

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.

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 radiolgraphically 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.

Details
Condition Cervical Radiculopathy, Cervical Root Compression
Treatment PF, ACDF
Clinical Study IdentifierNCT04177849
SponsorRegion Örebro County
Last Modified on5 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Symptoms of radiating arm pain with duration of at least six weeks
Neck disability index (NDI) over 30 points (60%)
Correlating findings on MRI on one or two cervical levels
Eligible for both treatments
Ability to understand and read Swedish

Exclusion Criteria

Previous cervical spine surgery
More then two cervical levels requiring treatment
Severe facet joint osteoarthritis
Symptoms or marked radiologic signs of myelopathy
Drug abuse
Dementia or expected low compliance
Cervical malformation
Marked instability, 3.5-mm translation or >11 degrees more motion compared to adjacent segments
History of severe cervical trauma
Generalized pain syndrome or WAD
Pregnancy
Rheumatoid arthritis
Ankylosing spondylitis
Malignancy
Active infection or another severe systemic disease
Patients that are unsuitable for either intervention deemed by the consultant spine surgeon
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