Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-02-19 @ 7:39 PM
Study NCT ID:
NCT02385695
Status:
UNKNOWN
Last Update Posted:
2015-09-28
First Post:
2015-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Safety and Effectiveness of Dynamic Stabilization Versus Lumbar Fusion in Treatment of Multilevel Lumbar Disc Degeneration Disease
Sponsor:
Qiang Zhou, MD. PhD.
Organization:
Study Overview
Official Title:
A Prospective Comparative Study to Evaluate Safety and Effectiveness of Dynamic Stabilization Versus Lumbar Fusion in Treatment of Multilevel Lumbar Disc Degeneration Disease
Status:
UNKNOWN
Status Verified Date:
2015-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MLIDH
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 Description:
Study aims are:
1. To evaluate superiority of Surgical treatment with posterior dynamic stabilization compared to Surgical treatment with internal fixation and fusion in lumbar range of motion;
2. 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;
3. To compare radiological, clinical, patient-reported and, safety outcomes between the two surgical approaches.
1. To evaluate superiority of Surgical treatment with posterior dynamic stabilization compared to Surgical treatment with internal fixation and fusion in lumbar range of motion;
2. 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;
3. To compare radiological, clinical, patient-reported and, safety outcomes between the two surgical approaches.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: