A Multicenter Registry-Based Study Across the Spectrum of Degenerative Cervical Myelopathy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWangjing Hospital, China Academy of Chinese Medical Sciences

About this trial

This is a multicenter, prospective, longitudinal, observational registry-based study of degenerative cervical myelopathy (DCM) across the full disease spectrum, linked to a disease-specific biobank. The study will enroll adults with non-myelopathic degenerative cervical cord compression, including asymptomatic degenerative cervical cord compression with or without radiculopathy, as well as patients with mild, moderate, or severe DCM. The study does not assign treatment or interfere with real-world clinical decision-making. All participants will undergo standardized baseline assessment, scheduled follow-up, and event-driven supplemental data collection. Core data include demographic information, comorbidities, disease characteristics, neurological examination, objective functional tests, patient-reported outcomes, cervical MRI findings, treatment pathway, treatment changes, adverse events, and long-term clinical outcomes. In participating centers, standardized biospecimen collection will be performed to support nested biomarker, immune, imaging, electrophysiological, and traditional Chinese medicine syndrome substudies. The main objective is to establish a standardized multicenter registry platform covering non-myelopathic degenerative cervical cord compression and mild, moderate, and severe DCM; to describe clinical trajectories, imaging evolution, treatment pathways, and long-term outcomes; and to identify factors associated with disease deterioration and functional prognosis.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18 years or older.

Cervical MRI confirms cervical spinal cord compression caused by degenerative pathology, including but not limited to disc protrusion or bulging, osteophyte formation, ligamentum flavum hypertrophy or ossification, ossification of the posterior longitudinal ligament, degenerative cervical canal stenosis, or other degenerative compressive factors.

At least one cervical level meets one or more of the following imaging criteria: partial or complete disappearance of the cerebrospinal fluid space around the spinal cord, direct contact between the spinal cord and degenerative compressive structures, focal spinal cord indentation, flattening or deformation, or other recognized imaging manifestations of degenerative cervical cord compression.

Meets one of the following clinical phenotypes: non-myelopathic degenerative cervical cord compression, with or without clinical radiculopathy; or clinically and radiologically confirmed mild, moderate, or severe degenerative cervical myelopathy.

Disqualifiers

Cervical spinal cord compression or myelopathy mainly caused by non-degenerative etiologies, such as acute trauma, tumor, infection, inflammatory or demyelinating disease, vascular lesion, obvious congenital malformation, or other non-degenerative spinal cord disease.

Presence of a dominant other neurological disease or severe psychiatric or cognitive disorder that, in the investigator's judgment, would clearly interfere with DCM-related neurological functional assessment or make reliable follow-up impossible.

Objective inability to complete the core imaging assessment or core follow-up and judged by the investigator to be unsuitable for inclusion in the main registry cohort.

Refusal to sign informed consent or explicit refusal of core data collection and follow-up.

Trial population

Adults with MRI-confirmed degenerative cervical spinal cord compression caused by degenerative pathology will be enrolled from spine outpatient clinics, inpatient wards, preoperative assessment pathways, postoperative follow-up, and imaging review pathways. The study population includes non-myelopathic degenerative cervical cord compression, with or without radiculopathy, and clinically and radiologically confirmed mild, moderate, or severe degenerative cervical myelopathy. All participants must be able to complete baseline core assessments, provide written informed consent, and participate in longitudinal follow-up.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Registry-based observation

    Other intervention

    Participants will receive routine clinical care according to real-world clinical decision-making. The study does not assign or mandate surgical or nonsurgical treatment. Clinical data, imaging data, follow-up outcomes, adverse events, and biospecimens will be collected according to the registry protocol.

Treatment groups

200 Participants
are divided into 5 treatment groups
Group A: A1: Non-myelopathic Degenerative Cervical Cord Compression Without Radiculopathy1 intervention
Group B: A2: Non-myelopathic Degenerative Cervical Cord Compression With Radiculopathy1 intervention
Group C: B1: Mild Degenerative Cervical Myelopathy1 intervention
Group D: B2: Moderate Degenerative Cervical Myelopathy1 intervention
Group E: B3: Severe Degenerative Cervical Myelopathy1 intervention

Trial outcomes

Primary outcomes

1

Time to First Composite Clinical Deterioration or Disease Progression Event

This outcome will be reported as the time from baseline to the first occurrence of any component of the predefined composite clinical deterioration or disease progression endpoint. The composite endpoint is considered to have occurred when a participant first experiences one or more of the following events: progression from non-myelopathic degenerative cervical cord compression to clinical degenerative cervical myelopathy, a decrease in mJOA score of at least 2 points from baseline; a new clinically meaningful neurological deficit or definite myelopathic sign; predefined worsening in symptom/function state; treatment escalation due to objective disease progression; new sphincter dysfunction; loss of independent ambulation; or another major functional event adjudicated by investigators. Participants without any component event will be censored at the last available follow-up. The unit of measure is months from baseline to the first composite event.

Time frame
Baseline to 36 months

Secondary outcomes

1

Time to First Treatment Pathway Conversion

This outcome will be reported as the time from baseline to the first treatment pathway conversion. Treatment pathway conversion is defined as a change from observation or regular follow-up to nonsurgical treatment, from observation or nonsurgical treatment to surgery, or another clinically justified treatment strategy change due to symptom worsening, neurological deterioration, imaging progression, or other objective disease progression. Participants without treatment pathway conversion will be censored at the last available follow-up. The unit of measure is months from baseline to first treatment pathway conversion.

Time frame
Baseline to 36 months
2

Time to First Cervical Spine Surgery During Follow-up

This outcome will be reported as the time from baseline to the first cervical spine surgery related to degenerative cervical cord compression or degenerative cervical myelopathy during follow-up. Cervical spine surgery includes cervical decompression, fusion, laminoplasty, or other DCM-related cervical surgical procedures. Participants without cervical spine surgery will be censored at the last available follow-up. The unit of measure is months from baseline to first cervical spine surgery.

Time frame
Baseline to 36 months
3

Time to First DCM-related Readmission

This outcome will be reported as the time from baseline to the first readmission related to degenerative cervical myelopathy, degenerative cervical cord compression, postoperative complications, disease recurrence, symptom aggravation, or other cervical spine-related causes. Participants without DCM-related readmission will be censored at the last available follow-up. The unit of measure is months from baseline to first DCM-related readmission.

Time frame
Baseline to 36 months
4

Time to First Cervical Spine Reoperation or Additional Cervical Intervention

This outcome will be reported as the time from baseline to the first cervical spine reoperation or additional cervical intervention related to degenerative cervical myelopathy, degenerative cervical cord compression, postoperative complications, disease recurrence, adjacent segment problems, or other cervical spine-related causes. Participants without reoperation or additional cervical intervention will be censored at the last available follow-up. The unit of measure is months from baseline to first reoperation or additional cervical intervention.

Time frame
Baseline to 36 months

Other outcomes

1

Change From Baseline in mJOA Score

This outcome will be reported as the change from baseline in the modified Japanese Orthopaedic Association score at each scheduled follow-up visit. The mJOA score is a clinician-administered neurological function scale for degenerative cervical myelopathy. The unit of measure is points on the mJOA scale.

Time frame
Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
2

Change From Baseline in JOA Score

This outcome will be reported as the change from baseline in the Japanese Orthopaedic Association score at each scheduled follow-up visit. The unit of measure is points on the JOA scale.

Time frame
Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
3

Change From Baseline in Nurick Grade

This outcome will be reported as the change from baseline in Nurick grade at each scheduled follow-up visit. The Nurick grade is an ordinal clinician-rated measure of gait-related functional impairment in cervical myelopathy. The unit of measure is grade on the Nurick scale.

Time frame
Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
4

Change From Baseline in Neck Disability Index Score

This outcome will be reported as the change from baseline in the Neck Disability Index score at each scheduled follow-up visit. The Neck Disability Index is a patient-reported questionnaire assessing neck-related disability. The unit of measure is points on the Neck Disability Index scale.

Time frame
Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months

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