Clinical trial NCT04177849: Örebro Multicenter Study on Operative Treatment of Cervical Radiculopathy
Official title: Örebro Multicenter Study on Operative Treatment of Cervical Radiculopathy: Anterior Cervical Decompression and Fusion Versus Posterior Foraminotomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Radiculopathy
Cervical Root Compression
Keywords: Pain
Nerve root dysfunction
Anterior Cervical Decompression and Fusion
Posterior Foraminotomy
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
name: Rygglkirurgiskt Centrum Stockholm AB
name: Norrlands University Hospital
First posted: 2019-11-26
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Neck Disability index, NDI.
timeFrame: 4-6 weeks, 3 months, 1 year, 2 year, 5 year
Secondary outcomes:
measure: EQ-5D
timeFrame: 4-6 weeks, 3 months, 1 year, 2 year, 5 year
measure: NRS neck, NRS arm
timeFrame: 4-6 weeks, 3 months, 1 year, 2 year, 5 year
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Ryggkirurgiskt Centrum Stockholm
city: Umeå
country: Sweden
facility: Norrlands Universitetssjukhus
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset Uppsala
city: Örebro
country: Sweden
facility: Universistessjukhuset Örebro
Study officials:
affiliation: Region Örebro County
name: Per Wretenberg, Prof. MD. PhD
role: STUDY_CHAIR
affiliation: Uppsala University
name: Claes Olerud, Prof. MD. PhD
role: STUDY_DIRECTOR
References:
citation: Holy M, MacDowall A, Sigmundsson FG, Olerud C. Operative treatment of cervical radiculopathy: anterior cervical decompression and fusion compared with posterior foraminotomy: study protocol for a randomized controlled trial. Trials. 2021 Sep 8;22(1):607. doi: 10.1186/s13063-021-05492-2.