NCT06528730 A Novel Surgical Criteria for Degenerative Cervical Myelopathy in Chinese Ethnicity
| NCT ID | NCT06528730 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Hong Kong |
| Condition | Degenerative Cervical Spinal Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2045-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-10-01 with a primary completion date of 2045-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Degenerative Cervical Myelopathy (DCM) is an age-related irreversible degenerative disease predominantly affecting the elderly aged 50 and over. DCM is usually triggered by ossification of the posterior longitudinal ligament or ossification of ligamentum flavum or prolapsed intervertebral disc over the cervical spine. Specific clinical signs characterized the presence of cervical spinal cord compression; including Hoffmann's sign, Finger Escape Sign, Scapulohumeral Reflex, and Reverse Supinator Reflex. Hand numbness, clumsiness, and gait disturbance. These are featured clinical manifestations and well-known indicators for detailed clinical and radiographic investigation, such as Magnetic Resonance Imaging (MRI) for diagnosis and surgical planning. Surgical intervention is considered to be the most effective treatment for DCM worldwide. It is the only evidence-based treatment to halt disease progression and allow modest improvement in function and quality of life. DCM progression is not specific to predict the timing for surgery, though it is still debated. Length of symptoms, pre-operative Modified Japanese Orthopaedic Association Scoring System for Cervical Myelopathy (mJOA) and physical performance are suggested as recovery predictors in DCM. In current practice, the offer of surgical treatment is entirely based on the combination of the evidence of cord compression in Magnetic Resonance Imaging (MRI) and mJOA. DCM who are at risk of critical neurological deficits have a reduced anteroposterior diameter of the spinal canal less than 9 mm or cross-sectional area of the spinal cord less than 40 sq. mm; mJOA less than 13 with evidence of functional deterioration will be offered with surgical intervention. MRI and mJOA are used as the golden standard for the indication of surgical intervention in the aspect of radiological deformities and self- perceived functional deficits. The concern on the clinical predictor, the physical performance, was overlooked and lacked a compromised criterion in the physical performance tests for surgical decisions. Therefore, this study aims to develop DCM-specific criteria from physical performance tests in predicting the surgical indication for DCM in the Chinese population.
Eligibility Criteria
Inclusion Criteria: * MRI confirmed Chinese DCM surgical candidates * All gender * Older than 45 years old * Independent walkers * No previous cervical spinal surgery * Cognitively capable of following instructions. Exclusion Criteria: * Active diagnosis of tuberculosis spine * Lumbar spinal diseases * Extra-pyramidal * Cerebral or cerebellar disorders * Peripheral neuropathies * Previous spinal operations * Unable to walk independently with or without aids * Non-communicable subjects and cognitively incapable of expressing their symptoms clearly
Contact & Investigator
Karlen Ka-pui Law, M. Phil
PRINCIPAL INVESTIGATOR
The University of Hong Kong
Frequently Asked Questions
Who can join the NCT06528730 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Degenerative Cervical Spinal Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06528730 currently recruiting?
Yes, NCT06528730 is actively recruiting participants. Contact the research team at karlenhk@connect.hku.hk for enrollment information.
Where is the NCT06528730 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06528730 clinical trial?
NCT06528730 is sponsored by The University of Hong Kong. The principal investigator is Karlen Ka-pui Law, M. Phil at The University of Hong Kong. The trial plans to enroll 100 participants.