Trial record 9 of 113 for:    Open Studies | "Lacerations"

Regenexx™ SD Versus Exercise Therapy for ACL Tears

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Regenerative Sciences, LLC
Sponsor:
Information provided by (Responsible Party):
Regenerative Sciences, LLC
ClinicalTrials.gov Identifier:
NCT01850758
First received: May 7, 2013
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Anterior Cruciate Ligament Tear
Procedure: Regenexx SD
Other: Exercise Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Regenexx™ SD Versus Exercise Therapy for Treatment of Partial and Complete, Non-retracted Anterior Cruciate Ligament Tears

Resource links provided by NLM:


Further study details as provided by Regenerative Sciences, LLC:

Primary Outcome Measures:
  • IKDC Subjective Knee Evaluation Score Change from Baseline [ Time Frame: Change from Baseline to 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint

  • Magnetic Resonance Evaluation of ligament repair [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Comparison between groups of Magnetic Resonance Evaluation of ligament repair at 3 months

  • Mean IKDC Subjective Knee Evaluation Scores [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Difference between treatment groups in mean KDC Subjective Knee Evaluation Scores at 6, 12 and 24 months.

  • Incidence of complications and adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Incidence and time to resolution of post-operative complications and adverse events between treatment groups.

  • Incidence of re-injection and surgical revision [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Incidence of and time to re-injection and surgical revision between treatment groups.

  • Use of pain medications [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Difference between treatment groups in use of pain medications at each follow-up timepoint


Estimated Enrollment: 50
Study Start Date: May 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Regenexx SD
Bone Marrow Aspirate Concentrate injected under imaging guidance into the area of the damaged ligament.
Procedure: Regenexx SD
Active Comparator: Exercise Therapy
Subjects will be instructed in a set of appropriate rotator cuff strengthening exercises and given an instructional hand-out to take home.
Other: Exercise Therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, MCL, 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,
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01850758

Contacts
Contact: Regenexx Information 1-888-525-3005 studycandidate@regenexx.com

Locations
United States, Colorado
Centeno-Schultz Clinic Recruiting
Broomfield, Colorado, United States, 80021
Principal Investigator: Christopher Centeno, MD         
Sub-Investigator: Ron Hanson, MD         
Sub-Investigator: John Schultz, MD         
Sub-Investigator: Ben Newton, MD         
Sponsors and Collaborators
Regenerative Sciences, LLC
Investigators
Principal Investigator: Christopher Centeno, MD Centeno-Schultz Clinic
  More Information

No publications provided

Responsible Party: Regenerative Sciences, LLC
ClinicalTrials.gov Identifier: NCT01850758     History of Changes
Other Study ID Numbers: RSI2013-RCT01
Study First Received: May 7, 2013
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Regenerative Sciences, LLC:
ACL
Anterior Cruciate Ligament
ACL Tear
Anterior Cruciate Ligament Tear
Partial ACL Tear

Additional relevant MeSH terms:
Lacerations
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on July 29, 2014