Fusion or no Fusion After Decompression of the Spinal Cord in Patients With Degenerative Cervical Myelopathy

NCT04936074 | Recruiting

• 1 other identifier: Uppsala2021
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Degenerative cervical myelopathy (DCM) is characterized by neck pain, neck stiffness, weakness, paresthesia, sphincter disturbance and balance disorder. The mean age for symptoms is 64 years and more men than women, 2.7:1, are affected. The most common level is C5-C6. DCM is the predominant cause of spinal cord dysfunction in the elderly worldwide. Surgical options include stand-alone laminectomy, laminectomy and fusion and laminoplasty. The preferable surgical approach is though, a matter of controversy. The objective of this study is to compare stand-alone laminectomy to laminectomy and fusion. Methods/Design: This is a multicenter randomized, controlled, parallel group non-inferiority trial. A total of 300 adult participants are allocated in a ratio of 1:1. The primary endpoint is reoperation for any reason within 5 years of follow-up. Sample size and power calculations were performed by estimating the reoperation rate after laminectomy to 3.4% and after laminectomy with fusion to 7.9% based on data from the Swedish spine registry (Swespine) on patients with DCM. Secondary outcomes are the patient derived modified Japanese orthopaedic association (P-mJOA) score, Neck disability index (NDI), European quality of life five dimensions (EQ-5D), Numeric rating scale (NRS) for neck and arm pain, Hospital anxiety and depression scale (HADS), development of kyphosis measured as the cervical sagittal vertical axis (cSVA) and, death. Clinical and radiological follow-up is performed at 3, 12, 24 and 60 months after surgery. The main inclusion criteria is 1-4 levels of DCM in the subaxial spine, C3-C7, with or without deformity. The REDcap will be used for safe data management. Data will be analyzed in the per protocol (PP) population, defined as randomized patients who are still alive without having emigrated or left the study after five years. Discussion: This will be the first randomized controlled trial comparing two of the most common surgical treatments for DCM; the posterior muscle-preserving selective laminectomy and posterior laminectomy with instrumented fusion. The results of the MyRanC study will provide surgical treatment recommendations for DCM. This may result in improvements in surgical treatment and clinical practice regarding DCM.

Conditions

Cervical Spondylotic Myelopathy

Keywords

Cervical fusion; Cervical spine; Laminectomy; Spinal surgery; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• The primary endpoint will be reoperation for any reason to reflect whether laminectomy alone or laminectomy with instrumented fusion results in fewer reoperations without increasing the frequency of complications.

  Reoperation will be considered in case of: * Postoperative hematoma or reperfusion injury with neurologic deterioration within hours/days after the primary surgery. * Change in sagittal alignment (kyphosis, DJK of more than 40 mm cSVA and/or C2-C7 Cobb \< -10°) with corresponding symptoms of camptocormia/increased pain/neurological deterioration. * ASP defined as degenerative changes on an adjacent level diagnosed with MRI and concomitant symptoms of myelopathy and/or radiculopathy. * Implant failure (clear radiolucency around \>1 screw or rod breakage with increased neck pain and/or neurologic deterioration). * Postoperative infection that requires revision surgery.

  Recorded at 5 years of follow-up

Secondary Outcomes (16)

• Change from baseline in myelopathy score on the patient derived modified Japanese Orthopedic Association scale (P-mJOA) at 2 years.

  Measured at baseline and 2 years of follow-up

• Change from baseline in participants disability score on the Neck disability index (NDI) at 2 years.

  Measured at baseline and 2 years of follow-up

• Change from baseline in myelopathy score on the Nurick scale at 2 years.

  Measured at baseline and 2 years of follow-up

• Change from baseline in the patient Quality of life five dimensions (EQ-5D index) at 2 years.

  Measured at baseline and 2 years of follow-up

• Change from baseline in pain scores on the Numeric rating scale (NRS) at 2 years.

  Measured at 2 years of follow-up

Study Arms (2)

Muscle preserving selective laminectomy (L-group)

EXPERIMENTAL

Muscle-preserving selective laminectomy with a posterior midline incision and dissection through the nuchal fascia. The spinous processes are split in the midline using a high-speed burr/ultrasound knife and without disturbing the deep extensor muscles on either side. Angulating away from the midline, the spinous processes are divided at their bases. Laminectomy is performed with a width no more than 2-3 mm wider than the dural borders. The facet joints are not exposed. Finally, the split spionous processes are sutured together. No collar or restrictions will be used in either group.

Procedure: Muscle preserving selective laminectomy

Laminectomy with instrumented fusion (LF-group)

ACTIVE COMPARATOR

Laminectomy with instrumented fusion with a midline incision over the appropriate levels defined as the same levels as the extension of laminectomy plus one level above and below but not extending beyond C3-C7. Soft tissue dissection and retraction is performed to identify osseous landmarks. Special care is taken to spare muscle attachments on C2 and C7. Spinal instrumentation is performed with lateral mass or pedicle screws (C3-C7) combined with rod fixation. Laminectomy is performed with a width not extending more than 2 mm outside the dural borders. Facet joint injury should be avoided. Special care is taken to spare the C7 spinous process and distal half of C7 lamina. The sagittal alignment is corrected before spinal fixation. No collar or restrictions will be used in either group.

Procedure: Laminectomy with instrumented fusion

Interventions

Muscle preserving selective laminectomy PROCEDURE

Muscle-preserving selective laminectomy differ from traditional laminectomy by the spinous process split that preserves the deep extensor muscles. The bilateral facet joints are not exposed. After the laminectomy is finished the split fragments of the spinous process are sutured together so that the deep extensor muscles are restored.

Muscle preserving selective laminectomy (L-group)

Laminectomy with instrumented fusion PROCEDURE

A traditional laminectomy is complemented with lateral mass and/or pedicle screws connected with rods.

Laminectomy with instrumented fusion (LF-group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years

You may not qualify if:

• Eligible for both treatments
• Ability to understand and read Swedish language
• Symptomatic myelopathy with at least one clinical sign of myelopathy
• No previous spine surgery
• Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures
• Personally, signed and dated informed consent document prior to any study-related procedures, indicating that the patient has been informed of all pertinent aspects of the trial
• Definition of kyphosis - cSVA \> 40 mm and/or C2-C7 Cobb \> 10° kyphosis. Definition of spondylolisthesis - anterior slippage of \> 2 mm on cervical radiographs taken in the neutral position.
• Local kyphosis; a modified K-line minimum interval distance (INT) of \<4 mm
• Spondylolisthesis \>4 mm and simultaneous translation \>2 mm on lateral flexion/extension radiographs
• Soft disc herniations only (no signs of osteophyte formation and hypertrophy of the ligamentum flavum)
• Active infection
• Neoplasm
• Trauma
• Inflammatory disease (i.e., rheumatoid arthritis or ankylosing spondylitis or DISH)
• Systemic disease including HIV

Sponsors & Collaborators

• Uppsala University Hospital: lead
• Karolinska Institutet: collaborator
• Linkoeping University: collaborator
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Academic Hospital of Uppsala

Uppsala, 75185, Sweden

RECRUITING

Related Publications (31)

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  PMID: 36765352 DERIVED

MeSH Terms

Conditions

Klippel-Feil Syndrome

Interventions

Laminectomy

Condition Hierarchy (Ancestors)

Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Decompression, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Study Officials

• Anna MacDowall, MD, PhD

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna MacDowall, MD, PhD

CONTACT

+46 730687087; anna.macdowall@surgsci.uu.se

Adrian Elmi-Terander, MD, PhD

CONTACT

+46 704716766; adrian.elmi-terander@karolinska.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: June 23, 2021
• Study Start: February 21, 2022
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2033
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)