Clinical trial NCT06528730: A Novel Surgical Criteria for Degenerative Cervical Myelopathy in Chinese Ethnicity
Official title: A Novel Surgical Criteria for Degenerative Cervical Myelopathy in Chinese Ethnicity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Degenerative Cervical Spinal Stenosis
Keywords: Degenerative cervical myelopathy
diagnosis
physical performance tests
surgeical criteria
functional deficits
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 patient with Degenerative Cervical Myelopathy will be recruited in DKCH

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.

Detailed description: Degenerative Cervical Myelopathy (DCM) is a prevalent degenerative spinal disease that often goes unnoticed by general clinicians due to its non-specific and subtle signs and symptoms in its early stages. Delayed identification of DCM may lead to poor surgical outcomes or permanent disability, impacting the quality of life of affected individuals.

Incoordination in hand and gait movements are early signs of DCM that worsen with disease progression. Despite validated performance tests for DCM, there is currently no objective criterion for functional deficits in aiding clinical decision-making for surgery or diagnosis.

To meet the pressing global need for objective functional criteria, this study aims to develop surgical criteria specific to DCM. This will involve using physical performance tests, in addition to evaluating MRI findings of cord compression, clinical signs, and the modified Japanese Orthopedic Association (mJOA). By expediting the surgical decision-making process, we hope to improve recovery outcomes for individuals with DCM worldwide

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

Primary outcomes:
measure: 10-second Grip and Release test (GR)
timeFrame: 24 months
measure: 10-second Stepping Test (SST) - no. of steps made in 10 seconds
timeFrame: 24 months
measure: Foot Tapping Test (FTT)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Duchess of Kent Children's Hospital at Sandy Bay
Study officials:
affiliation: The University of Hong Kong
name: Karlen Ka-pui Law, M. Phil
role: PRINCIPAL_INVESTIGATOR
References:
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