Clinical Research Directory

Hard Cervical Collar Use Following Posterior Cervical Fusion

Postoperative immobilization with a hard cervical collar following posterior cervical fusion remains common practice despite limited evidence demonstrating improved clinical outcomes. This is a prospective, multi-site, randomized clinical trial evaluating postoperative hard cervical collar use following posterior cervical fusion for degenerative cervical spine disease. Eligible patients will be randomized to either wear an FDA-approved hard cervical collar (Aspen Cervical Collar, Aspen Vista Cervical Collar, or Miami J Cervical Collar) for 6 weeks after surgery or receive no cervical collar. Patient-reported outcomes will be collected before surgery and at 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months after surgery. The primary outcome is radiographic fusion success at 12 months. Secondary outcomes include neck disability, neck and arm pain, quality of life, patient satisfaction, wound infection, adverse events, and other postoperative complications. Radiographic fusion will be evaluated by blinded radiologists. The results of this study will help determine whether routine postoperative cervical collar use improves outcomes following posterior cervical fusion.

Patient Reported Recovery of Muscle Strength After Surgery for Cervical Radiculopathy, Impact of Duration and Severity on Recovery.

DCR surgery is generally recommended for patients with severe or progressive limb paresis. The incidence of motor weakness reported to be up to 70%, with a varying recovery rate up to 90%, and the prospects of recovery is most likely dependent on paresis severity and duration. Operative treatment could facilitate earlier recovery, but the evidence is weak and based on smaller and heterogeneous DCM/DCR populations. There is also a lack of knowledge concerning timing of surgery, i.e. the influence of paresis duration, surgical delay and preoperative paresis. It is also unclear if there is an association between the underlying DCR pathology (disc herniation, spondylosis or both) and prognosis. The aim of this sub-study is to assess the frequency and severity of limb preoperative paresis in patients operated for DCR, and to improve prognostication of recovery and timing of surgery. To the best of our knowledge, these issues have not been properly investigated previously. New knowledge in this field is highly sought by clinicians and can Inform patients, and physicians in shared decision making, i.e. helping them to choose more wisely between different treatment strategies. New insight in this field would be also be useful in clinical guideline development, for reducing surgical practice variation, for modifying outcome expectations, improve patient selection (clinical guideline development) and clinical outcomes of DCR surgery.

Validity of the Turkish Translation of the Modified JOA

Degenerative cervical myelopathy (DCM) is the most common cause of non-traumatic spinal cord dysfunction in adults and may lead to progressive motor, sensory, and autonomic impairment. Accurate and standardized assessment of neurological function is essential for clinical decision-making, prognostic evaluation, and comparison of treatment outcomes. The Modified Japanese Orthopaedic Association (mJOA) score is one of the most widely used clinician-based outcome measures for evaluating neurological status in patients with DCM. Although the mJOA has been translated and validated in several languages, no validated Turkish version currently exists. This prospective, cross-sectional validation study aims to culturally adapt the mJOA score into Turkish and evaluate its validity, reliability, and clinical correlation in Turkish-speaking patients diagnosed with DCM. Adult patients (≥18 years) with clinically and radiologically confirmed DCM presenting to the outpatient clinics of Physical Medicine and Rehabilitation and Neurosurgery will be included. Previously obtained cervical magnetic resonance imaging will be reviewed retrospectively to determine myelomalacia levels, while clinical scales will be administered prospectively. Construct validity will be assessed by examining correlations between the Turkish mJOA scores and the Neck Disability Index, as well as the Nurick grading system. Inter-rater reliability will be evaluated using the Intraclass Correlation Coefficient (ICC \[2,1\]) between two independent evaluators, and test-retest reliability will be assessed in clinically stable patients after 7-14 days. Feasibility will be evaluated by recording the administration time and potential difficulties during application. This study is expected to provide a valid and reliable Turkish version of the mJOA score, facilitating standardized assessment of DCM in Turkish clinical practice and enabling comparability with international research.