Comparing two surgical methods for treating cervical radiculopathy
Örebro Multicenter Study on Operative Treatment of Cervical Radiculopathy: Anterior Cervical Decompression and Fusion Versus Posterior Foraminotomy
This study is testing which surgery works better for people with neck pain from nerve issues: one that approaches from the front or one that approaches from the back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Region Örebro County Academic / other |
| Locations | 4 sites (Stockholm and 3 other locations) |
| Trial ID | NCT04177849 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of anterior cervical decompression and fusion (ACDF) versus posterior foraminotomy (PF) in treating cervical radiculopathy caused by nerve root compression. It is a multicenter, prospective, randomized trial involving 110 patients who have not responded to non-surgical treatment for at least six weeks. Participants will be followed for two years, with primary outcomes measured using the Neck Disability Index (NDI) and secondary outcomes including pain ratings and quality of life assessments. The study aims to provide high-level evidence to inform clinical guidelines regarding these surgical techniques.
Who should consider this trial
Good fit: Ideal candidates are patients experiencing radiating arm pain for at least six weeks, with a Neck Disability Index score over 30 points and suitable for both surgical treatments.
Not a fit: Patients with previous cervical spine surgery, severe osteoarthritis, or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the most effective surgical approach for patients with cervical radiculopathy, potentially improving patient outcomes and reducing complications.
How similar studies have performed: While both surgical techniques have been used effectively, this study is novel in its comparative approach with a high level of evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stockholm and 3 other locations
- Ryggkirurgiskt Centrum Stockholm — Stockholm, Sweden (Recruiting)
- Norrlands Universitetssjukhus — Umeå, Sweden (Not_yet_recruiting)
- Akademiska Sjukhuset Uppsala — Uppsala, Sweden (Recruiting)
- Universistessjukhuset Örebro — Örebro, Sweden (Recruiting)
Study contacts
- Study coordinator: Marek Holy, MD
- Email: marek.holy@regionorebrolan.se
- Phone: +46 0196025323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.