Compare Different Cervical Anterior Discectomy Procedures by After Procedure Sagittal Alignment on Radiograph

Study Overview
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Brief Summary
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Patients with single-level cervical degenerative disc disease commonly undertook anterior discectomy. To compare the effect of anterior cervical discectomy without fusion (ACD), anterior cervical discectomy with fusion by stand-alone cage (ACDF) or anterior cervical discectomy with arthroplasty (ACDA)， a multiple center randomised controlled trial will be performed in patients with single-level cervical disease. The primary outcome will be cervical alignment by upright cervical spine radiographs estimated by Harrison posterior tangent method.

Detailed Description
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This study will use a multiple center open-label randomised controlled trial to estimate the effect of ACD, ACDF, ACDA for single-level cervical degenerative disc. Patients with arm pain not responding to conservative treatment take part in this trial. They will be randomised assigned into 3 parallel arms. The participants in the each arm will undertake ACD ACDF or ACDA. The baseline is the day of surgery. The Harrison posterior tangent method was used as an estimate for measuring cervical alignment. The primary outcome will be the cervical sagittal alignment estimated by Harrison posterior tangent method.

Official Title
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Compare Different Cervical Anterior Discectomy Procedures for Cervical Degenerative Disc Disease by After Procedure Sagittal Alignment on Radiograph :a Multiple Center Randomized Controlled Trial

Conditions
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Cervical Disc Degeneration

Intervention / Treatment
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* Procedure: ACD
* Procedure: ACDF
* Procedure: ACDA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with arm pain not responding to conservative treatment lasted longer than 10 weeks single level disc degeneration mobile spine on dynamic lateral cervical X-rays Exclusion Criteria: severe cardiopulmonary comorbidity suspected underlying malignant disease radicular syndrome spinal-cord compression syndrome contraindication for radiography

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: grade 1<br>ACD | Procedure: ACD<br>* Undertake anterior cervical discectomy without fusion<br>|
| Active Comparator: grade 2<br>ACDF | Procedure: ACDF<br>* anterior cervical discectomy with fusion<br>|
| Active Comparator: grade 3<br>ACDA | Procedure: ACDA<br>* anterior cervical discectomy with arthroplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of cervical alignment | The Harrison posterior tangent method was used as an estimate for curvature | 1 day postoperatively, 6 weeks, 3 months, 1 year and 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) | 1 day postoperatively, 6 weeks, 3 months, 1 year and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Disc Degeneration, cervical anterior discectomy, Spinal alignment