Back to results

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

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Osteoarthritis, Knee, Arthritis, TKA, Total Knee Arthroplasty

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

NCT ID

NCT02034032

First Posted

January 9, 2014

Last Updated

January 3, 2019

Sponsor

Regenexx, LLC

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

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

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

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

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs