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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
Sponsor:
Information provided by (Responsible Party):
Regenexx, LLC

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Procedure: Regenexx SD Behavioral: Exercise Therapy Not Applicable

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 They will be withdrawn from the study prematurely if a revision occurs.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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Illinois
Regenerative Pain Center; Weil Foot, Ankle and Orthopedic Institute
Des Plaines, Illinois, United States, 60016
Sponsors and Collaborators
Regenexx, LLC
Investigators
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Principal Investigator: Mitchell Sheinkop, M.D. Regenerative Pain Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Regenexx, LLC
ClinicalTrials.gov Identifier: NCT02034032     History of Changes
Other Study ID Numbers: MM-03-K
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Regenexx, LLC:
Osteoarthritis
Knee
Arthritis
TKA
Total Knee Arthroplasty
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases