Regenexx™ SD Versus Exercise Therapy for Treatment of Knee Osteoarthritis With Historical Comparison to TKA
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|ClinicalTrials.gov Identifier: NCT02034032|
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : January 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Procedure: Regenexx SD Behavioral: Exercise Therapy||Not Applicable|
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 They will be withdrawn from the study prematurely if a revision occurs.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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of Regenexx™ SD Versus Exercise Therapy for Treatment of Knee Osteoarthritis With Historical Comparison to Total Knee Arthroplasty|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||December 2018|
Active Comparator: Regenexx SD
Regenexx-SD (Same Day) is a bone marrow based injection procedure.
Procedure: Regenexx SD
stem cell treatment
Active Comparator: Exercise Therapy
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
exercise therapy control
- Knee Society Scores [ Time Frame: 3 months ]Mean difference of Knee Society Scores for assessment and function between the treatment groups measured at 3 months
- KSS means difference between Regenexx SD and historical TKA data [ Time Frame: 1 year ]The KSS means difference between Regenexx SD and historical TKA data measured at 1 year
- KSS means difference between Regenexx SD and historical TKA data [ Time Frame: 2 year ]The KSS means difference between Regenexx SD and historical TKA data measured at 2 years
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034032
|United States, Illinois|
|Regenerative Pain Center; Weil Foot, Ankle and Orthopedic Institute|
|Des Plaines, Illinois, United States, 60016|
|Principal Investigator:||Mitchell Sheinkop, M.D.||Regenerative Pain Center|