Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528730
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-07
Brief Title:
A Novel Surgical Criteria for Degenerative Cervical Myelopathy in Chinese Ethnicity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Novel Surgical Criteria for Degenerative Cervical Myelopathy in Chinese Ethnicity
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Hoffmanns 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None