Outcomes Data of Bone Marrow Stem Cells to Treat Hip and Knee Osteoarthritis
- Conditions
- Hip and Knee Osteoarthritis
- Interventions
- Other: Procedural, Bone Marrow concentrate injection
- Registration Number
- NCT01601951
- Lead Sponsor
- Regenerative Pain Center, Illinois
- Brief Summary
The purpose of this study is to determine if Bone Marrow Concentrate may be successful in the treatment of osteoarthritis. Bone Marrow Concentrate is known to contain a community of cells that has been shown to have "regenerative" properties. This study is designed to evaluate the short-term clinical and x-ray outcomes of injections for hip and knee osteoarthritis.
Inclusion Criteria:
* Subjects must be scheduled for an autologous bone marrow hip or knee injection
* Subjects must have a diagnosis of hip or knee osteoarthritis
* Subjects must be between the ages of 18 and 85
* Subjects must be willing and able to sign Informed Consent
* Subjects must be willing and able to return for scheduled follow-up evaluations
Exclusion Criteria:
* Subjects who have had any type of visco-supplementation in the treated joint within the last three months prior to enrollment
* Subjects for whom baseline data is not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- Subjects must be scheduled for an autologous bone marrow hip or knee injection
- Subjects must have a diagnosis of hip or knee osteoarthritis
- Subjects must be between the ages of 18 and 85
- Subjects must be willing and able to sign Informed Consent
- Subjects must be willing and able to return for scheduled follow-up evaluations
- Subjects who have had any type of visco-supplementation in the treated joint within the last three months prior to enrollment
- Subjects for whom baseline data is not available
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Hip Osteoarthritis Procedural, Bone Marrow concentrate injection - Knee Osteoarthritis Procedural, Bone Marrow concentrate injection -
- Primary Outcome Measures
Name Time Method Visual Analog Pain Scale Baseline, 6 weeks, 3 months, 1 year Change in subjective pain measure
Harris Hip Score or Knee Society Score Baeline, 6 weeks, 3 months, 1 year Change in subjective pain, function, functional activity measurement and a clinical physical exam
Physician Global Assessment Baseline, 6 weeks, 3 months, 1 year Change in physician rated disease activity measurement
- Secondary Outcome Measures
Name Time Method Radiologic Baseline, 1 year Radiographic changes of the hip or knee
Trial Locations
- Locations (1)
Regenerative Pain Center
🇺🇸Des Plaines, Illinois, United States