Are rigid cervical collars necessary for patients undergoing open-door laminoplasty and titanium arch plates for cervical myelopathy? – a randomized pilot clinical trial

Abstract

Introduction and Project Objectives: Cervical collars are used after laminoplasty to protect the hinge opening, reduce risks of hinge fractures and avoid springback phenomena. However, its use may lead to reduced range of motion, axial neck pain and increased cost. We aim to investigate the clinical, radiological and functional outcomes of patients undergoing hinge laminoplasty with or without cervical collar immobilization by randomized controlled trial. Methods: This was a prospective, parallel single-blinded randomized controlled trial. Patients undergoing laminoplasty for cervical myelopathy were randomly allocated into two groups based on the use of collar postoperatively for 3 weeks. Clinical assessments included cervical range of motion, axial pain (visual analogue scale/VAS), and objective scores (36-item short form/SF-36, Neck disability index/NDI, modified Japanese Orthopaedic Association/mJOA). Patients’ group allocation was blinded to 3 assessors during radiographic measurements which included cervical alignment, spinal canal diameter and complications (implant loosening, springback). All assessments were per formed preoperatively and at postoperative 1-week, 2-weeks, 3-weeks, 6-weeks, 3-months, 6-months and 12-months. Comparative analysis was performed via analysis of variance adjusted by the baseline scores, sex and age as covariates. Results: A total of 35 patients with mean age of 64.9±11.4 years at surgery were consecutively recruited and randomized to collar use (n=16) and without collar immobilization (n=19). All patients completed all follow-up assessments without dropout, and had no complications. There were no differences between groups at baseline. Subjects had comparable mJOA scores, SF-36, NDI and range of motion at postoperative timepoints. Patients without collar use had higher VAS at postoperative 1-week (5.4 vs 3.5; p=0.038) and 2-weeks (3.5 vs 1.5; p=0.028) but subsequently follow-up revealed no differences between the two groups. Conclusion: The use of a rigid collar after laminoplasty leads to less axial neck pain in the first two weeks after surgery. However, there is no additional benefit with regards to range of motion, quality of life, and complication risk. This difference in pain response only impacts in the initial postoperative period and does not impact the overall quality of life of patients.