Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Study aims are:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posterior Dynamic Stabilization | Surgical treatment with posterior dynamic stabilization |
| |
| Internal Fixation and Fusion | Surgical treatment with internal fixation and fusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posterior Dynamic Stabilization | Procedure |
| ||
| Internal Fixation and Fusion |
| Measure | Description | Time Frame |
|---|---|---|
| Range of Motion in Lumbar Spine | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oswestry Disability Index | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale for Back Pain | 24 Months | |
| Numeric Rating Scale for Leg Pain | 24 Months | |
| Range of Motion in Sagittal Plane at Each Operated Level |
Inclusion Criteria:
Signed informed consent
Age between 30 and 75 years inclusive
Radiographic evidence of multi-level lumbar disc degeneration disease
Scheduled for 2- or 3-level lumbar discectomy at levels from L1 to S1 with or without dynamic stabilization or fusion
Preoperative ODI ≥ 30%
Clinical symptoms consistent with diagnosis of lumbar DDD:
Failed to gain adequate symptom relief from at least one month of adequate non-operative treatment
Exclusion Criteria:
Not provided
Not provided
Patients of The Third Medical University/Southwest Hospital with multilevel lumbar degenerative disk disease.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiang Zhou, MD, PhD | Contact | 86-13677669899 | zq_tlh@163.com | |
| Branko Kopjar, MD, PhD | Contact | 1-206-607-6861 | branko.kopjar@nor-consult.com |
| Name | Affiliation | Role |
|---|---|---|
| Qiang Zhou, MD, PhD | Third Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Third Military Medical University/Southwest Hospital | Recruiting | Chongqing | China |
Not provided
Not provided
Not provided
Not provided
| Procedure |
|
| 24 Months |
| Radiographic Evaluations by Woodend Classification and Modic Changes on MRI | 24 Months |
| ID | Term |
|---|---|
| D005593 | Fracture Fixation, Internal |
| D050939 | Gene Fusion |
| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D011995 | Recombination, Genetic |
| D055614 | Genetic Phenomena |
Not provided
Not provided