Örebro Multicenter Study on Operative Treatment of Cervical Radiculopathy
NCT ID: NCT04177849
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2020-01-20
2026-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Anterior Cervical Decompression and Fusion (ACDF)
Patients entered into this arm are treated via an anterior approach with disk excision, root canal decompression and fusion of the affected segment with a cage and plate.
ACDF
A 4-cm anterolateral transverse incision is made over the index level, on either the right or left side. Platysma is sectioned transversal to its fibers and the anterior aspect of the spinal column is bluntly exposed between the carotid sheath and the esophagus. The disk is excised, including the posterior longitudinal ligament. Disk fragments and/or osteophytes from the uncovertebral joint on the affected side are removed until the root is fully decompressed. Reconstruction is typically done with an interbody spacer, autologous bone graft and a stabilizing plate screwed to the adjacent vertebral bodies. A fusion cage with integrated screws may also be used according to the surgeon's preference.
Posterior Foraminotomy (PF)
Patients entered into this arm are treated via a posterior approach through intermuscular planes. The root canal is decompressed by burring the medial third of the facet joint. No fusion is performed.
PF
A 4-cm longitudinal midline incision exposes the spinous processes of the adjacent vertebrae. The facet joint covering the index foramen is exposed through intermuscular planes. The root canal is opened as the medial third of the facet joint is removed with a high-speed diamond burr. The affected nerve root is decompressed by laterally undercutting the facet joint throughout its length.
Interventions
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ACDF
A 4-cm anterolateral transverse incision is made over the index level, on either the right or left side. Platysma is sectioned transversal to its fibers and the anterior aspect of the spinal column is bluntly exposed between the carotid sheath and the esophagus. The disk is excised, including the posterior longitudinal ligament. Disk fragments and/or osteophytes from the uncovertebral joint on the affected side are removed until the root is fully decompressed. Reconstruction is typically done with an interbody spacer, autologous bone graft and a stabilizing plate screwed to the adjacent vertebral bodies. A fusion cage with integrated screws may also be used according to the surgeon's preference.
PF
A 4-cm longitudinal midline incision exposes the spinous processes of the adjacent vertebrae. The facet joint covering the index foramen is exposed through intermuscular planes. The root canal is opened as the medial third of the facet joint is removed with a high-speed diamond burr. The affected nerve root is decompressed by laterally undercutting the facet joint throughout its length.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Uppsala University Hospital
OTHER
Rygglkirurgiskt Centrum Stockholm AB
OTHER
Norrlands University Hospital
OTHER
Region Örebro County
OTHER
Responsible Party
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Marek Holy
Principal Investigator, Head of Spine Unit
Principal Investigators
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Per Wretenberg, Prof. MD. PhD
Role: STUDY_CHAIR
Region Örebro County
Claes Olerud, Prof. MD. PhD
Role: STUDY_DIRECTOR
Uppsala University
Locations
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Universistessjukhuset Örebro
Örebro, , Sweden
Ryggkirurgiskt Centrum Stockholm
Stockholm, , Sweden
Norrlands Universitetssjukhus
Umeå, , Sweden
Akademiska Sjukhuset Uppsala
Uppsala, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Marek Holy, MD
Role: primary
References
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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.
Other Identifiers
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2019-00003
Identifier Type: -
Identifier Source: org_study_id
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