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

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: Regenexx SD; Behavioral: Exercise Therapy

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 They will be withdrawn from the study prematurely if a revision occurs.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

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Des Plaines, Illinois, United States, 60016
      • Regenerative Pain Center; Weil Foot, Ankle and Orthopedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Regenexx, LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: January 9, 2014
• First Submitted That Met QC Criteria: January 9, 2014
• First Posted (ESTIMATE): January 13, 2014

Study Record Updates

• Last Update Posted (ACTUAL): January 4, 2019
• Last Update Submitted That Met QC Criteria: January 3, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Arthritis; Osteoarthritis; Knee; Total Knee Arthroplasty; TKA
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: MM-03-K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO