Outcomes Data of Bone Marrow Stem Cells to Treat Hip and Knee Osteoarthritis

Study Overview
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Brief Summary
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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

Official Title
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Autologous Bone Marrow Concentrate Database Outcomes Research Project

Conditions
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Hip and Knee Osteoarthritis

Intervention / Treatment
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* Other: Procedural, Bone Marrow concentrate injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hip Osteoarthritis<br> | Other: Procedural, Bone Marrow concentrate injection<br>* This is strictly data collection and outcomes based. The procedure is not part of this study<br>|
| Knee Osteoarthritis<br> | Other: Procedural, Bone Marrow concentrate injection<br>* This is strictly data collection and outcomes based. The procedure is not part of this study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Pain Scale | Change in subjective pain measure | Baseline, 6 weeks, 3 months, 1 year | 
| Harris Hip Score or Knee Society Score | Change in subjective pain, function, functional activity measurement and a clinical physical exam | Baeline, 6 weeks, 3 months, 1 year | 
| Physician Global Assessment | Change in physician rated disease activity measurement | Baseline, 6 weeks, 3 months, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiologic | Radiographic changes of the hip or knee | Baseline, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Stem Cell Injections, Bone Marrow, Autologous