Clinical Trial: Study to Evaluate Safety and Effectiveness of Dynamic Stabilization Versus Lumbar Fusion in Treatment of Multilevel Lumbar Disc Degeneration Disease
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: A Prospective Comparative Study to Evaluate Safety and Effectiveness of Dynamic Stabilization Versus Lumbar Fusion in Treatment of Multilevel Lumbar Disc Degeneration Dise
Brief Summary: The purpose of this study is to compare outcomes of (i) surgical treatment with posterior dynamic stabilization and (ii) surgical treatment with internal fixation and fusion in patients with multilevel lumbar degenerative disk disease.
Detailed Summary:
Study aims are:
- To evaluate superiority of Surgical treatment with posterior dynamic stabilization compared to Surgical treatment with internal fixation and fusion in lumbar range of motion;
- To compare Surgical treatment with posterior dynamic stabilization compared to Surgical treatment with internal fixation and fusion in functional outcomes as measured by change in Oswestry Disability Index;
- To compare radiological, clinical, patient-reported and, safety outcomes between the two surgical approaches.
Sponsor: Qiang Zhou, MD. PhD.
Current Primary Outcome: Range of Motion in Lumbar Spine [ Time Frame: 24 Months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Change in Oswestry Disability Index [ Time Frame: 24 Months ]
Original Secondary Outcome: Same as current
Information By: Third Military Medical University
Dates:
Date Received: February 26, 2015
Date Started: March 2015
Date Completion: August 2021
Last Updated: September 24, 2015
Last Verified: September 2015
