Degenerative Spinal Cord Disease Clinical Trial
Official title:
Single-Level TLIF: Post-Fusion Rehabilitation
Verified date | September 2021 |
Source | Rush University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This investigation will assess how the timing and type of rehabilitation after a transforaminal lumbar interbody fusion will affect the efficacy of the surgical procedure. The efficacy of the procedure will be evaluated through patients' quality of life, measured by health-related quality of life questionnaires up to 24 months following the procedure. These measures will be compared to the patients' baseline value.
Status | Completed |
Enrollment | 66 |
Est. completion date | September 1, 2021 |
Est. primary completion date | September 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: i. Single-level L4-L5 TLIF for degenerative pathology, including: radiculopathy, neurogenic claudication, intervertebral disc disease, facet joint disease, degenerative spondylolisthesis, degenerative myelopathy degenerative kyphosis and scoliosis ii. Back and/or leg pain iii. Failed at least 3 months of conservative treatment Exclusion Criteria: i. Older than 65 years of age ii. Prior spinal surgery excluding laminectomy/discectomy iii. Greater than Grade 2 spondylolisthesis iv. Greater than 10 degrees scoliosis v. Not worked for greater than 6 months or unemployed as a result of lumbar condition vi. History of spinal infection |
Country | Name | City | State |
---|---|---|---|
United States | Carla Edwards | Evanston | Illinois |
Lead Sponsor | Collaborator |
---|---|
Rush University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in Oswestry Disability Index [ODI] Score at 2-years | Oswestry Disability Index | Baseline, 2-year postoperative | |
Secondary | Radiographic fusion | Radiographic fusion at L4-5 levels as measured by computed tomography scan | Baseline, 1-year postoperative | |
Secondary | Change from baseline in walking ability at 2-years | Walking test performed for 6 minutes | Baseline, 2 years postoperative | |
Secondary | Change from baseline in walking speed at 2-years | Walking test performed for 6 minutes | Baseline, 2 years postoperative | |
Secondary | Change from baseline in Visual Analogue Scale [VAS] Pain Scores at 2-years | Visual Analogue Scale | Baseline, 2 year postoperative | |
Secondary | Change from baseline in Short-Form 12 [SF-12] Scores at 2-years | Short-Form 12 | Baseline, 2 year postoperative | |
Secondary | Change from baseline PROMIS Physical Function Scores at 2-years | PROMIS Physical Function | Baseline, 2 year postoperative | |
Secondary | Change from baseline in Fear Avoidance Beliefs Metric at 2-years | Fear Avoidance Beliefs Questionnaire | Baseline, 2 year postoperative | |
Secondary | Change from baseline in Pain Catastrophization Metric at 2-years | Pain Catastrophization Questionnaire | Baseline, 2 year postoperative | |
Secondary | Change from baseline in Pain Neurophysiology Metric at 2-years | Pain Neurophysiology Questionnaire | Baseline, 2 year postoperative |