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Regenexx™ SD Versus Exercise Therapy for ACL Tears

Primary Purpose

Anterior Cruciate Ligament Tear

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 Anterior Cruciate Ligament Tear focused on measuring ACL, Anterior Cruciate Ligament, ACL Tear, Anterior Cruciate Ligament Tear, Partial ACL Tear

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pain, swelling, or functional disability in the affected knee with activity, having failed conservative treatment (e.g. NSAIDs, physician initiated physical therapy) for at least 3 months or unable to return to normal day to day activities by 6 weeks
Physical examination consistent with lax ACL ligament (Anterior Drawer Test)
Abnormal Telos Arthrometer measurement
Positive diagnostic MR imaging of the affected knee with at least 1/3 of the ACL ligament at any area along its length having high signal on MRI PDFS/Fat Sat images.
Full range of motion of the affected knee (other than restriction clearly due to effusion)
Normal range of motion of the non-treated knee
Is independent, ambulatory, and can comply with all post-operative evaluations and visits

Exclusion Criteria:

A massive ACL tear or one that includes more than 2/3'rds of the ligament that's retracted.
Previous surgery to the affected ACL (i.e. previous ACL replacement with an autograft or allograft)
Prior ACL prolotherapy, PRP, corticosteroid injection or other injection therapy within the past three months,
Concomitant meniscus tear or cartilage injury that occurred at the same time as the as the ACL tear and which is considered a pain generator by the treating physician at the time intake into the study (i.e. a meniscus tear or cartilage lesion associated with an active BML).
Concomitant PCL or LCL tears
Inflammatory or auto-immune based joint diseases or other lower extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
Quinolone or Statin induced myopathy/ tendinopathy
Kellgren-Lawrence grade 2 or greater knee osteoarthritis
Significant knee extension lag compared to the opposite knee
Symptomatic lumbar spine pathology (e.g. radicular pain)
Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh
Contraindications for MRI
Tested positive or has been treated for a malignancy in the past or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed injection site
Condition represents a worker's compensation case
Currently involved in a health-related litigation procedure
Is pregnant
Bleeding disorders
Currently taking anticoagulant or immunosuppressive medication
Allergy or intolerance to study medication
Use of chronic opioid,

Sites / Locations

Centeno-Schultz Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Regenexx SD

Exercise Therapy

Arm Description

Bone Marrow Aspirate Concentrate injected under imaging guidance into the area of the damaged ligament.

Subjects will be instructed in a set of appropriate knee strengthening exercises and given an instructional hand-out to take home.

Outcomes

Primary Outcome Measures

IKDC Subjective Knee Evaluation Score Change from Baseline

The primary endpoint for this study is the difference between treatment groups in the within patient mean change from baseline to 3 months in IKDC scores.

Secondary Outcome Measures

Mean Pain Scales

Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint

Magnetic Resonance Evaluation of ligament repair

Comparison of Magnetic Resonance Evaluation of ligament repair at 6 months

Mean IKDC Subjective Knee Evaluation Scores

Difference between treatment groups in mean KDC Subjective Knee Evaluation Scores at 6, 12 and 24 months.

Incidence of complications and adverse events

Incidence and time to resolution of post-operative complications and adverse events between treatment groups.

Incidence of re-injection and surgical revision

Incidence of and time to re-injection and surgical revision between treatment groups.

Use of pain medications

Difference between treatment groups in use of pain medications at each follow-up timepoint

Full Information

NCT ID

NCT01850758

First Posted

May 7, 2013

Last Updated

July 6, 2022

Sponsor

Regenexx, LLC

1. Study Identification

Unique Protocol Identification Number

NCT01850758

Brief Title

Regenexx™ SD Versus Exercise Therapy for ACL Tears

Official Title

A Randomized Controlled Trial of Regenexx™ SD Versus Exercise Therapy for Treatment of Partial and Complete, Non-retracted Anterior Cruciate Ligament Tears

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

May 22, 2020 (Actual)

Study Completion Date

March 8, 2022 (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 compare the improvement in subject-reported clinical outcomes for Regenexx SD vs. Exercise Therapy treatment of partial and complete, non-retracted knee ACL ligament tears, from baseline to 3 months, with continued evaluation of efficacy and durability up to 24 months. Secondary objectives include evaluation of MRI evidence of tendon repair; incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.

Detailed Description

Prospective, randomized, controlled to include 25 subjects treated with Regenexx SD and 25 subjects treated with exercise therapy alone with the exercise group crossing over to the injection group at 3 months. Subjects will have a partial or complete, non-retracted ACL ligament tear as evidenced with MRI. 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. The primary endpoint analysis will be conducted once all subjects reach the 3 month endpoint. Subjects will continue to be followed through the 2 year endpoint with data analysis performed at the 1 year and 2 year time points.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anterior Cruciate Ligament Tear

Keywords

ACL, Anterior Cruciate Ligament, ACL Tear, Anterior Cruciate Ligament Tear, Partial ACL Tear

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Regenexx SD

Arm Type

Active Comparator

Arm Description

Bone Marrow Aspirate Concentrate injected under imaging guidance into the area of the damaged ligament.

Arm Title

Exercise Therapy

Arm Type

Active Comparator

Arm Description

Subjects will be instructed in a set of appropriate knee strengthening exercises and given an instructional hand-out to take home.

Intervention Type

Procedure

Intervention Name(s)

Regenexx SD

Intervention Description

stem cell treatment

Intervention Type

Other

Intervention Name(s)

Exercise Therapy

Intervention Description

exercise therapy control

Primary Outcome Measure Information:

Title

IKDC Subjective Knee Evaluation Score Change from Baseline

Description

The primary endpoint for this study is the difference between treatment groups in the within patient mean change from baseline to 3 months in IKDC scores.

Time Frame

Change from Baseline to 3 months

Secondary Outcome Measure Information:

Title

Mean Pain Scales

Description

Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint

Time Frame

3, 6, 12 and 24 months

Title

Magnetic Resonance Evaluation of ligament repair

Description

Comparison of Magnetic Resonance Evaluation of ligament repair at 6 months

Time Frame

6 months

Title

Mean IKDC Subjective Knee Evaluation Scores

Description

Difference between treatment groups in mean KDC Subjective Knee Evaluation Scores at 6, 12 and 24 months.

Time Frame

6, 12 and 24 months

Title

Incidence of complications and adverse events

Description

Incidence and time to resolution of post-operative complications and adverse events between treatment groups.

Time Frame

24 months

Title

Incidence of re-injection and surgical revision

Description

Incidence of and time to re-injection and surgical revision between treatment groups.

Time Frame

24 months

Title

Use of pain medications

Description

Difference between treatment groups in use of pain medications at each follow-up timepoint

Time Frame

3, 6, 12 and 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pain, swelling, or functional disability in the affected knee with activity, having failed conservative treatment (e.g. NSAIDs, physician initiated physical therapy) for at least 3 months or unable to return to normal day to day activities by 6 weeks Physical examination consistent with lax ACL ligament (Anterior Drawer Test) Abnormal Telos Arthrometer measurement Positive diagnostic MR imaging of the affected knee with at least 1/3 of the ACL ligament at any area along its length having high signal on MRI PDFS/Fat Sat images. Full range of motion of the affected knee (other than restriction clearly due to effusion) Normal range of motion of the non-treated knee Is independent, ambulatory, and can comply with all post-operative evaluations and visits Exclusion Criteria: A massive ACL tear or one that includes more than 2/3'rds of the ligament that's retracted. Previous surgery to the affected ACL (i.e. previous ACL replacement with an autograft or allograft) Prior ACL prolotherapy, PRP, corticosteroid injection or other injection therapy within the past three months, Concomitant meniscus tear or cartilage injury that occurred at the same time as the as the ACL tear and which is considered a pain generator by the treating physician at the time intake into the study (i.e. a meniscus tear or cartilage lesion associated with an active BML). Concomitant PCL or LCL tears Inflammatory or auto-immune based joint diseases or other lower extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout) Quinolone or Statin induced myopathy/ tendinopathy Kellgren-Lawrence grade 2 or greater knee osteoarthritis Significant knee extension lag compared to the opposite knee Symptomatic lumbar spine pathology (e.g. radicular pain) Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh Contraindications for MRI Tested positive or has been treated for a malignancy in the past or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed injection site Condition represents a worker's compensation case Currently involved in a health-related litigation procedure Is pregnant Bleeding disorders Currently taking anticoagulant or immunosuppressive medication Allergy or intolerance to study medication Use of chronic opioid,

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher Centeno, MD

Organizational Affiliation

Centeno-Schultz Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centeno-Schultz Clinic

City

Broomfield

State/Province

Colorado

ZIP/Postal Code

80021

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Regenexx™ SD Versus Exercise Therapy for ACL Tears

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