Regenexx™ SD Versus Exercise Therapy for Treatment of Knee Osteoarthritis With Historical Comparison to TKA
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Regenexx SD
Exercise Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Osteoarthritis, Knee, Arthritis, TKA, Total Knee Arthroplasty
Eligibility Criteria
Inclusion Criteria:
- Voluntary signature of the IRB approved Informed Consent
- Ages 18 to 70
- Diagnosis of Knee osteoarthritis
- Kellgren-Lawrence Grade 2 or 3 on X-Ray
- BMI of <30
- Minimum flexion to 110 degrees
- Varus under 12 degrees/Valgus under 15 degrees
- Instability in any plane less than 2 mm translation
- ACL intact and no history of ACL reconstruction
- Knee Society 100 point score > 65
- If bilateral arthritis, subject must be able and willing to delay treatment of the second side for at least 6 months
- Candidate is able to follow Regenexx medication guidelines
- Patient agrees to return for periodic assessment protocol
- Patient must execute all required documents
- Patient must be appraised of Clinical Trial
Exclusion Criteria:
- History of infection of the joint in the last five years
- Intra-articular PRP, steroid or viscosupplementation in the last three months
- Previous knee surgery within the last 6 months
- Flexion contracture over 15 degrees
- Low back pain with radiculopathy or with "significant" radiographic changes
- History of immunosuppressive or chemotherapy in the last five years
- Systemic neurological disease
- HIV positive or chronic hepatitis
- Any significant co-morbidity that in the opinion of the investigator should exclude the subject from the study
Sites / Locations
- Regenerative Pain Center; Weil Foot, Ankle and Orthopedic Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Regenexx SD
Exercise Therapy
Arm Description
Regenexx-SD (Same Day) is a bone marrow based injection procedure.
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.
Outcomes
Primary Outcome Measures
Knee Society Scores
Mean difference of Knee Society Scores for assessment and function between the treatment groups measured at 3 months
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02034032
Brief Title
Regenexx™ SD Versus Exercise Therapy for Treatment of Knee Osteoarthritis With Historical Comparison to TKA
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 Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regenexx, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Osteoarthritis, Knee, Arthritis, TKA, Total Knee Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regenexx SD
Arm Type
Active Comparator
Arm Description
Regenexx-SD (Same Day) is a bone marrow based injection procedure.
Arm Title
Exercise Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Regenexx SD
Intervention Description
stem cell treatment
Intervention Type
Behavioral
Intervention Name(s)
Exercise Therapy
Intervention Description
exercise therapy control
Primary Outcome Measure Information:
Title
Knee Society Scores
Description
Mean difference of Knee Society Scores for assessment and function between the treatment groups measured at 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
KSS means difference between Regenexx SD and historical TKA data
Description
The KSS means difference between Regenexx SD and historical TKA data measured at 1 year
Time Frame
1 year
Title
KSS means difference between Regenexx SD and historical TKA data
Description
The KSS means difference between Regenexx SD and historical TKA data measured at 2 years
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Voluntary signature of the IRB approved Informed Consent
Ages 18 to 70
Diagnosis of Knee osteoarthritis
Kellgren-Lawrence Grade 2 or 3 on X-Ray
BMI of <30
Minimum flexion to 110 degrees
Varus under 12 degrees/Valgus under 15 degrees
Instability in any plane less than 2 mm translation
ACL intact and no history of ACL reconstruction
Knee Society 100 point score > 65
If bilateral arthritis, subject must be able and willing to delay treatment of the second side for at least 6 months
Candidate is able to follow Regenexx medication guidelines
Patient agrees to return for periodic assessment protocol
Patient must execute all required documents
Patient must be appraised of Clinical Trial
Exclusion Criteria:
History of infection of the joint in the last five years
Intra-articular PRP, steroid or viscosupplementation in the last three months
Previous knee surgery within the last 6 months
Flexion contracture over 15 degrees
Low back pain with radiculopathy or with "significant" radiographic changes
History of immunosuppressive or chemotherapy in the last five years
Systemic neurological disease
HIV positive or chronic hepatitis
Any significant co-morbidity that in the opinion of the investigator should exclude the subject from the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Sheinkop, M.D.
Organizational Affiliation
Regenerative Pain Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regenerative Pain Center; Weil Foot, Ankle and Orthopedic Institute
City
Des Plaines
State/Province
Illinois
ZIP/Postal Code
60016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30545387
Citation
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.
Results Reference
derived
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Regenexx™ SD Versus Exercise Therapy for Treatment of Knee Osteoarthritis With Historical Comparison to TKA
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