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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.
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 They will be withdrawn from the study prematurely if a revision occurs.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regenexx SD | Active Comparator | Regenexx-SD (Same Day) is a bone marrow based injection procedure. |
|
| Exercise Therapy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regenexx SD | Procedure | stem cell treatment |
| |
| Exercise Therapy |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Sheinkop, M.D. | Regenerative Pain Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regenerative Pain Center; Weil Foot, Ankle and Orthopedic Institute | Des Plaines | Illinois | 60016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30545387 | Derived | Centeno C, Sheinkop M, Dodson E, Stemper I, Williams C, Hyzy M, Ichim T, Freeman M. A specific protocol of autologous bone marrow concentrate and platelet products versus exercise therapy for symptomatic knee osteoarthritis: a randomized controlled trial with 2 year follow-up. J Transl Med. 2018 Dec 13;16(1):355. doi: 10.1186/s12967-018-1736-8. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Behavioral |
exercise therapy control |
|
The KSS means difference between Regenexx SD and historical TKA data measured at 2 years
| 2 year |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |