Cervical RadiculopathyOMSAPNCT04177849
Örebro Multicenter Study on Operative Treatment of Cervical Radiculopathy
A study testing ACDF and PF in people with Cervical Radiculopathy and Cervical Root Compression, run by Region Örebro County at 4 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Radiculopathy, Cervical Root Compression
- What is being tested?
- ACDF and PF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 4 sitesSweden
- Study dates
- 20 Jan 2020to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites, 4 recruiting
- Recruiting
Universistessjukhuset Örebro
Örebro, 701 85
Marek Holy, MD
- Recruiting
Ryggkirurgiskt Centrum Stockholm
Stockholm, 114 33
Martin Skeppsholm, MD. PhD, +46 08 12458100, martin.skeppholm@RKC.se
- Not yet recruiting
Norrlands Universitetssjukhus
Umeå, 90737
Lukas Bobinski, MD. PhD, +46 090 785 00 00, lukas.bobinski@vll.se
- Recruiting
Akademiska Sjukhuset Uppsala
Uppsala, 75185
Claes Olerud, Prof. MD. PhD, +46 018 611 72 24, claes.olerud@surgsciuu.se
About this study
Official title: Örebro Multicenter Study on Operative Treatment of Cervical Radiculopathy: Anterior Cervical Decompression and Fusion Versus Posterior Foraminotomy
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.
Read the 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.
- Conditions
- Cervical Radiculopathy, Cervical Root Compression
- Being tested
- ACDF, PF
- Keywords
- Pain, Nerve root dysfunction, Anterior Cervical Decompression and Fusion, Posterior Foraminotomy
- Medical subject headings
- Radiculopathy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACDFProcedure or surgery
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.
PFProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Anterior Cervical Decompression and Fusion (ACDF) | Active comparator | 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. Receives: Procedure: ACDF |
| Posterior Foraminotomy (PF) | Experimental | 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. Receives: Procedure: PF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability index, NDI.
Primary variable is NDI change at two year compared to baseline. NDI is a self-administered questionnaire with 10 items measuring disability in patients with neck pain. The questions cover daily activities, such as the ability to dress, lift heavy objects, read, work, drive a car, sleep and perform leisure time activities, as well as the amount of pain, headache and concentration abilities. Each item is scored from 0 to 5. MCID for NDI is 7,5-8,5 or 17,3%.
NDI change will also be measured at different time intervals to highlight the change over time.
Measured: 4-6 weeks, 3 months, 1 year, 2 year, 5 year
Secondary outcomes (2)
EQ-5D
Secondary variable is EQ-5D change at two year compared to baseline. EQ-5D, The European Quality of Life-5 Dimensions (EQ-5D; with a range from approximately -0.5 to 1, with higher scores indicating better quality of life) using the Swedish translation [36, 37].
EQ-5D change will also be measured at different time intervals to highlight the change over time.
Measured: 4-6 weeks, 3 months, 1 year, 2 year, 5 year
NRS neck, NRS arm
Numerical Rating Scale (NRS) for pain is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number 0 no pain to 10 worst pain imaginable that best reflects the intensity of their pain. MCID is 2.2 point for NRS
NRS change will also be measured at different time intervals to highlight the change over time
Measured: 4-6 weeks, 3 months, 1 year, 2 year, 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start20 Jan 2020
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital, Rygglkirurgiskt Centrum Stockholm AB, Norrlands University Hospital
- Responsible party
- Principal investigator, Marek Holy, Region Örebro County
- Investigators
- Per Wretenberg, Prof. MD. PhD, Study chair, Region Örebro CountyClaes Olerud, Prof. MD. PhD, Study director, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177849
- Sponsor's protocol ID
- 2019-00003
- Other IDs
- 2019
- Acronym
- OMSAP
- Status last verified
- Nov 2023
- First submitted
- 19 Nov 2019
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34496941
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Örebro Multicenter Study on Operative Treatment of Cervical Radiculopathy: Anterior Cervical Decompression and Fusion Versus Posterior Foraminotomy
- ClinicalTrials.gov ID
- NCT04177849
- Acronym / sponsor ID
- OMSAP / 2019-00003
- Conditions
- Cervical Radiculopathy, Cervical Root Compression
- Keywords
- Pain, Nerve root dysfunction, Anterior Cervical Decompression and Fusion, Posterior Foraminotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Uppsala University Hospital, Rygglkirurgiskt Centrum Stockholm AB, Norrlands University Hospital
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior Cervical Decompression and Fusion (ACDF) | Active comparator | Procedure: ACDFPatients 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. |
| Posterior Foraminotomy (PF) | Experimental | Procedure: PFPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- Previous cervical spine surgery
- More then two cervical levels requiring treatment
- Severe facet joint osteoarthritis
- Symptoms or marked radiologic signs of myelopathy
- Drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACDFA 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. | Procedure or surgery | Anterior Cervical Decompression and Fusion (ACDF) |
| PFA 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. | Procedure or surgery | Posterior Foraminotomy (PF) |
Primary outcome
Neck Disability index, NDI.
Time frame: 4-6 weeks, 3 months, 1 year, 2 year, 5 year
Primary variable is NDI change at two year compared to baseline. NDI is a self-administered questionnaire with 10 items measuring disability in patients with neck pain. The questions cover daily activities, such as the ability to dress, lift heavy objects, read, work, drive a car, sleep and perform leisure time activities, as well as the amount of pain, headache and concentration abilities. Each item is scored from 0 to 5. MCID for NDI is 7,5-8,5 or 17,3%. NDI change will also be measured at different time intervals to highlight the change over time.
2 secondary outcomes
EQ-5D
Time frame: 4-6 weeks, 3 months, 1 year, 2 year, 5 year
NRS neck, NRS arm
Time frame: 4-6 weeks, 3 months, 1 year, 2 year, 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 34496941Holy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Wretenberg, Prof. MD. PhD study chair
Region Örebro County
Claes Olerud, Prof. MD. PhD study director
Uppsala University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACDF and PF in people with Cervical Radiculopathy and Cervical Root Compression, run by Region Örebro County at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marek Holy, MD (+46 0196025323, marek.holy@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability index, NDI. (time frame: 4-6 weeks, 3 months, 1 year, 2 year, 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04177849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.