Regenexx™ SD Versus Exercise Therapy for Treatment of Knee Osteoarthritis With Historical Comparison to TKA

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the efficacy of Regenexx SD compared to Exercise Therapy at three months. Historical comparison will be made to Total Knee Arthroplasty for treatment of knee osteoarthritis at 1 and 2 years.

Detailed Description
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The study is single center, prospective, randomized, controlled trial to include 50 subjects, 25 treated with Regenexx SD and 25 treated with Exercise Therapy for treatment of knee osteoarthritis. Subjects will be enrolled within 60 days prior to Regenexx-SD injection or initiation of Exercise Therapy and take part in follow-up visits for two years following treatment. A preoperative visit will occur at the time of enrollment; follow-up visits will occur at the clinical site at 6 weeks, 3 months, 6 months, 12 months, and 24 months post injection. Subjects in the control, exercise therapy arm, will have the opportunity to cross-over to the study treatment arm at or after the 3 month visit and then continue to be followed through 24 months. Subjects will complete the study following the 2 year follow-up visit. They will be withdrawn from the study prematurely if a revision occurs. The study subjects will be compared to a historical total knee arthroplasty group. Data of the TKA group subjects will be reviewed retrospectively after it is retrieved from the clinical database. The TKA group will consist of patients who underwent TKA for knee osteoarthritis. The inclusion criteria of age and BMI will be applied to these subjects.

Official Title
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A Randomized Controlled Trial of Regenexx™ SD Versus Exercise Therapy for Treatment of Knee Osteoarthritis With Historical Comparison to Total Knee Arthroplasty

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Regenexx SD
* Behavioral: Exercise Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntary signature of the IRB approved Informed Consent Ages 18 to 70 Diagnosis of Knee osteoarthritis Kellgren-Lawrence Grade 2 or 3 on X-Ray BMI of <30 Minimum flexion to 110 degrees Varus under 12 degrees/Valgus under 15 degrees Instability in any plane less than 2 mm translation ACL intact and no history of ACL reconstruction Knee Society 100 point score > 65 If bilateral arthritis, subject must be able and willing to delay treatment of the second side for at least 6 months Candidate is able to follow Regenexx medication guidelines Patient agrees to return for periodic assessment protocol Patient must execute all required documents Patient must be appraised of Clinical Trial Exclusion Criteria: History of infection of the joint in the last five years Intra-articular PRP, steroid or viscosupplementation in the last three months Previous knee surgery within the last 6 months Flexion contracture over 15 degrees Low back pain with radiculopathy or with significant radiographic changes History of immunosuppressive or chemotherapy in the last five years Systemic neurological disease HIV positive or chronic hepatitis Any significant co-morbidity that in the opinion of the investigator should exclude the subject from the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Regenexx SD<br>Regenexx-SD (Same Day) is a bone marrow based injection procedure. | Procedure: Regenexx SD<br>* stem cell treatment<br>|
| Active Comparator: Exercise Therapy<br>Subjects in the Exercise Therapy group will attend an initial session with a trained Physical Therapist. During that session the physical therapist will instruct the subject in a home exercise program and instructions about activity limitations. The subject's progress will also be followed by the Physical Therapist during the 6 week follow-up visit with further instructions provided. | Behavioral: Exercise Therapy<br>* exercise therapy control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Scores | Mean difference of Knee Society Scores for assessment and function between the treatment groups measured at 3 months | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KSS means difference between Regenexx SD and historical TKA data | The KSS means difference between Regenexx SD and historical TKA data measured at 1 year | 1 year | 
| KSS means difference between Regenexx SD and historical TKA data | The KSS means difference between Regenexx SD and historical TKA data measured at 2 years | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TKA, Osteoarthritis, Knee, Arthritis, Total Knee Arthroplasty