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

NCT ID: NCT02034032

Last Updated: 2019-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2018-12-31

Brief Summary

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

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 They will be withdrawn from the study prematurely if a revision occurs.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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Regenexx SD

Regenexx-SD (Same Day) is a bone marrow based injection procedure.

Group Type: ACTIVE_COMPARATOR

Regenexx SD

Intervention Type: PROCEDURE

stem cell treatment

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.

Group Type: ACTIVE_COMPARATOR

Exercise Therapy

Intervention Type: BEHAVIORAL

exercise therapy control

Interventions

Regenexx SD

stem cell treatment

Intervention Type: PROCEDURE

Exercise Therapy

exercise therapy control

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Voluntary signature of the IRB approved Informed Consent

2. Ages 18 to 70

3. Diagnosis of Knee osteoarthritis

4. Kellgren-Lawrence Grade 2 or 3 on X-Ray

5. BMI of <30

6. Minimum flexion to 110 degrees

7. Varus under 12 degrees/Valgus under 15 degrees

8. Instability in any plane less than 2 mm translation

9. ACL intact and no history of ACL reconstruction

10. Knee Society 100 point score > 65

11. If bilateral arthritis, subject must be able and willing to delay treatment of the second side for at least 6 months

12. Candidate is able to follow Regenexx medication guidelines

13. Patient agrees to return for periodic assessment protocol

14. Patient must execute all required documents

15. Patient must be appraised of Clinical Trial

Exclusion Criteria

1. History of infection of the joint in the last five years

2. Intra-articular PRP, steroid or viscosupplementation in the last three months

3. Previous knee surgery within the last 6 months

4. Flexion contracture over 15 degrees

5. Low back pain with radiculopathy or with "significant" radiographic changes

6. History of immunosuppressive or chemotherapy in the last five years

7. Systemic neurological disease

8. HIV positive or chronic hepatitis

9. Any significant co-morbidity that in the opinion of the investigator should exclude the subject from the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regenexx, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitchell Sheinkop, M.D.

Role: PRINCIPAL_INVESTIGATOR

Regenerative Pain Center

Locations

Regenerative Pain Center; Weil Foot, Ankle and Orthopedic Institute

Des Plaines, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30545387 (View on PubMed)

Other Identifiers

MM-03-K

Identifier Type: -

Identifier Source: org_study_id