A Novel Surgical Criteria for Degenerative Cervical Myelopathy in Chinese Ethnicity

NCT06528730 | Recruiting

• 1 other identifier: UW 23-242
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Cervical Spinal Stenosis

Keywords

Degenerative cervical myelopathy; diagnosis; physical performance tests; surgeical criteria; functional deficits

Outcome Measures

Primary Outcomes (3)

• 10-second Grip and Release test (GR)

  Counting the no. of grip-release repetitions made in 10 seconds

  24 months

• 10-second Stepping Test (SST) - no. of steps made in 10 seconds

  Counting the no. of stepping repetitions made in 10 seconds

  24 months

• Foot Tapping Test (FTT)

  Counting the no. of foot taps repetitions made in 10 seconds

  24 months

Interventions

DCM DIAGNOSTIC_TEST

Confirm degenerative cervical myelopathy by Orthopaedic surgeon and MRI

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 patient with Degenerative Cervical Myelopathy will be recruited in DKCH

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The Duchess of Kent Children's Hospital at Sandy Bay

Hong Kong, 000, Hong Kong

RECRUITING

Related Publications (9)

• Fehlings MG, Tetreault LA, Riew KD, Middleton JW, Aarabi B, Arnold PM, Brodke DS, Burns AS, Carette S, Chen R, Chiba K, Dettori JR, Furlan JC, Harrop JS, Holly LT, Kalsi-Ryan S, Kotter M, Kwon BK, Martin AR, Milligan J, Nakashima H, Nagoshi N, Rhee J, Singh A, Skelly AC, Sodhi S, Wilson JR, Yee A, Wang JC. A Clinical Practice Guideline for the Management of Patients With Degenerative Cervical Myelopathy: Recommendations for Patients With Mild, Moderate, and Severe Disease and Nonmyelopathic Patients With Evidence of Cord Compression. Global Spine J. 2017 Sep;7(3 Suppl):70S-83S. doi: 10.1177/2192568217701914. Epub 2017 Sep 5.

  PMID: 29164035 RESULT

• Hilton B, Tempest-Mitchell J, Davies B, Kotter M. Assessment of degenerative cervical myelopathy differs between specialists and may influence time to diagnosis and clinical outcomes. PLoS One. 2018 Dec 17;13(12):e0207709. doi: 10.1371/journal.pone.0207709. eCollection 2018.

  PMID: 30557368 RESULT

• Tetreault L, Kopjar B, Nouri A, Arnold P, Barbagallo G, Bartels R, Qiang Z, Singh A, Zileli M, Vaccaro A, Fehlings MG. The modified Japanese Orthopaedic Association scale: establishing criteria for mild, moderate and severe impairment in patients with degenerative cervical myelopathy. Eur Spine J. 2017 Jan;26(1):78-84. doi: 10.1007/s00586-016-4660-8. Epub 2016 Jun 24.

  PMID: 27342612 RESULT

• Yukawa Y, Nakashima H, Ito K, Machino M, Kanbara S, Kato F. Quantifiable tests for cervical myelopathy; 10-s grip and release test and 10-s step test: standard values and aging variation from 1230 healthy volunteers. J Orthop Sci. 2013 Jul;18(4):509-13. doi: 10.1007/s00776-013-0381-6. Epub 2013 Apr 6.

  PMID: 23564077 RESULT

• Pribble BA, Black CD, Larson DJ, Larson RD. An evaluation of the reliability of the foot-tapping test in a healthy sample. Foot (Edinb). 2021 Sep;48:101851. doi: 10.1016/j.foot.2021.101851. Epub 2021 Jul 12.

  PMID: 34385026 RESULT

• Nakashima H, Yukawa Y, Ito K, Machino M, Kanbara S, Morita D, Imagama S, Hamajima N, Ishiguro N, Kato F. Validity of the 10-s step test: prospective study comparing it with the 10-s grip and release test and the 30-m walking test. Eur Spine J. 2011 Aug;20(8):1318-22. doi: 10.1007/s00586-011-1733-6. Epub 2011 Mar 6.

  PMID: 21380747 RESULT

• Kalsi-Ryan S, Singh A, Massicotte EM, Arnold PM, Brodke DS, Norvell DC, Hermsmeyer JT, Fehlings MG. Ancillary outcome measures for assessment of individuals with cervical spondylotic myelopathy. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S111-22. doi: 10.1097/BRS.0b013e3182a7f499.

  PMID: 23963009 RESULT

• Machino M, Ando K, Kobayashi K, Morozumi M, Tanaka S, Ito K, Kato F, Ishiguro N, Imagama S. Cut off value in each gender and decade of 10-s grip and release and 10-s step test: A comparative study between 454 patients with cervical spondylotic myelopathy and 818 healthy subjects. Clin Neurol Neurosurg. 2019 Sep;184:105414. doi: 10.1016/j.clineuro.2019.105414. Epub 2019 Jul 5.

  PMID: 31306894 RESULT

• Yukawa Y, Kato F, Ito K, Horie Y, Nakashima H, Masaaki M, Ito ZY, Wakao N. "Ten second step test" as a new quantifiable parameter of cervical myelopathy. Spine (Phila Pa 1976). 2009 Jan 1;34(1):82-6. doi: 10.1097/BRS.0b013e31818e2b19.

  PMID: 19127165 RESULT

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karlen Ka-pui Law, M. Phil

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karlen Ka-pui Law, M. Phil

CONTACT

29740531; karlenhk@connect.hku.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: July 30, 2024
• Study Start: October 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)