NCT04936074: MyRanC

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

Recruiting now NA Last updated 8 April 2025

What this trial tests

NA trial testing Muscle preserving selective laminectomy in Cervical Spondylotic Myelopathy in 300 participants. Currently enrolling.

Timeline

21 February 2022

Primary endpoint
1 February 2030

1 February 2033

Quick facts

Lead sponsor	Uppsala University Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	21 February 2022
Primary completion	1 February 2030
Estimated completion	1 February 2033
Sites	1 location across Sweden

Drugs / interventions tested

• Muscle preserving selective laminectomy
• Laminectomy with instrumented fusion

Conditions studied

• Cervical Spondylotic Myelopathy — all drugs for Cervical Spondylotic Myelopathy →

Sponsor

Uppsala University Hospital

Who can join

18 and older, any sex, with Cervical Spondylotic Myelopathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comparison of posterior muscle-preserving selective laminectomy and laminectomy with fusion for treating cervical spondylotic myelopathy: study protocol for a randomized controlled trial.
   MacDowall A, Löfgren H, Edström E, Brisby H, et al · · 2023 · cited 5× · PMID 36765352 · DOI 10.1186/s13063-023-07123-4
2. Comparison of posterior muscle-preserving selective laminectomy and laminectomy with fusion for treating cervical spondylotic myelopathy: study protocol for a randomized controlled trial
   MacDowall A, Löfgren H, Edström E, Brisby H, et al · · 2022 · DOI 10.21203/rs.3.rs-1528674/v1