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

Cervical Disc Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03360409
• Other study ID #: CACD3
• Status: Not yet recruiting
• Phase: N/A
• First received: November 26, 2017
• Last updated: November 30, 2017
• Start date: February 1, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: November 2017
• Source: Peking University People's Hospital
• Contact: chen guo
• Phone: 8618055644700
• Email: fantasy_g[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Disc Degeneration
• Intervertebral Disc Degeneration
• Spinal Diseases

Intervention

Procedure:
• ACD
Undertake anterior cervical discectomy without fusion
• ACDF
anterior cervical discectomy with fusion
• ACDA
anterior cervical discectomy with arthroplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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