Hip and Knee Osteoarthritis
Conditions
Keywords
Osteoarthritis, Stem Cell Injections, Bone Marrow, Autologous
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
Interventions
OTHERProcedural, Bone Marrow concentrate injection
This is strictly data collection and outcomes based. The procedure is not part of this study
Sponsors
Regenerative Pain Center, Illinois
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Radiologic | Baseline, 1 year | Radiographic changes of the hip or knee |
Countries
United States
Outcome results
None listed