Trials / Unknown
UnknownNCT03360409
Compare Different Cervical Anterior Discectomy Procedures by After Procedure Sagittal Alignment on Radiograph
Compare Different Cervical Anterior Discectomy Procedures for Cervical Degenerative Disc Disease by After Procedure Sagittal Alignment on Radiograph :a Multiple Center Randomized Controlled Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Peking University People's Hospital · Academic / Other
- Sex
- All
- Age
- 50 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | ACD | Undertake anterior cervical discectomy without fusion |
| PROCEDURE | ACDF | anterior cervical discectomy with fusion |
| PROCEDURE | ACDA | anterior cervical discectomy with arthroplasty |
Timeline
- Start date
- 2018-02-01
- Primary completion
- 2020-01-01
- Completion
- 2020-06-01
- First posted
- 2017-12-04
- Last updated
- 2017-12-04
Source: ClinicalTrials.gov record NCT03360409. Inclusion in this directory is not an endorsement.