Mechanical Debridement vs. Radiofrequency-Based Debridement to Treat Articular Cartilage Legions With Partial Meniscectomy in the Knee (ACT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Smith & Nephew, Inc.
Information provided by (Responsible Party):
Smith & Nephew, Inc. Identifier:
First received: February 15, 2013
Last updated: March 2, 2016
Last verified: March 2016
The purpose of this study is to evaluate changes in clinical and imaging outcomes following arthroscopic treatment of a single medial femoral chondral lesion plus partial medial meniscectomy by Radiofrequency-Based debridement or Mechanical Debridement in subjects ≥ eighteen (18) years of age.

Condition Intervention
Chondral Lesion Plus Partial Medial Meniscectomy
Device: Mechanical Debridement (Mechanical Shaver)
Device: Radiofrequency-Based Debridement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Double Blinded, Multicenter, Randomized, Controlled Trial to Evaluate Mechanical Debridement vs. Radiofrequency-Based Debridement in the Treatment of Articular Cartilage Lesions

Further study details as provided by Smith & Nephew, Inc.:

Primary Outcome Measures:
  • Knee and Osteoarthritis Outcomes Scores (KOOS) [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
    Change in Knee and Osteoarthritis Outcomes Scores (KOOS) scores post-operative compared to baseline

Secondary Outcome Measures:
  • International Knee Documentation(IKDC)Subjective Knee Evaluation Form [ Time Frame: Screening/Baseline, Week 6, 12, 24, 36, 52 and 104 ] [ Designated as safety issue: No ]
    Change in International Knee Documentation (IKDC) scores from post-operative compared to baseline

  • International Knee Documentation Committee (IKDC)Knee Examination Form score [ Time Frame: Weeks 6, 12, 24, 36 52, and 104 ] [ Designated as safety issue: No ]
    Change in International Knee Documentation Committee (IKDC) Knee Examination Form scores from baseline

  • Change in Knee and Osteoarthritis Outcomes Scores (KOOS) scores [ Time Frame: Weeks 6, 12, 24, 36 and 104 ] [ Designated as safety issue: No ]
    Change in KOOS scores from baseline

  • Visual Analogue Scale, (VAS) Knee Pain [ Time Frame: Day 10, week 6, 12, 24, 36, 52 and 104 ] [ Designated as safety issue: No ]
    the change from baseline

  • SF-12 [ Time Frame: Weeks 6, 12, 24, 36, 52 and 104 ] [ Designated as safety issue: No ]
    Change in SF-12 scores from baseline

  • EQ-5D-5L [ Time Frame: Day 10, weeks 6, 12, 24, 36, 52 and 104 ] [ Designated as safety issue: No ]
    Change in EQ-5D-5L scores from baseline

  • Magnetic Resonance Imaging (MRI) [ Time Frame: Day 10, weeks 52 and 104 ] [ Designated as safety issue: No ]
    MRI assessments at Day 10, Weeks 52 and 104

  • Subject Satisfaction [ Time Frame: Weeks 52 and 104 ] [ Designated as safety issue: No ]
    Subject Satisfaction at Weeks 52 and 104

Estimated Enrollment: 106
Study Start Date: March 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mechanical Debridement (Mechanical Shaver)
Mechanical shaver removes areas of damaged tissue
Device: Mechanical Debridement (Mechanical Shaver)
mechanical shaver that removes areas of damaged tissue
Other Name: Mechanical Shaver
Active Comparator: Radiofrequency-based Debridement
Electrical energy removes areas of damaged tissue (Coblation®)
Device: Radiofrequency-Based Debridement
Electrical energy that removes areas of damaged tissue (Coblation®)
Other Name: Paragon® T2™ ICW wand


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Subjects MUST meet ALL of the following criteria to be included in the study:

  1. Given written informed consent on the IRB/REB approved Consent Form specific to the study, prior to study participation
  2. Is male or non pregnant female ≥ eighteen (18) years of age
  3. Arthroscopic confirmation of a lesion requiring treatment meeting the following parameters:

    1. Single, treatable chondral lesion, localized to the medial femoral condyle,
    2. ICRS Grade 3A,
    3. < 4cm2 in size
  4. MRI within past 6 months confirming presence of a medial femoral chondral lesion and medial meniscal tear requiring a partial meniscectomy
  5. Must present with pain in the index knee of moderate or severe (> 30 mm) as measured by the VAS
  6. Must be able to understand English (written and oral)
  7. Must be available to come to all study related visits and is physically and mentally willing and able to comply with all post-operative evaluations
  8. Must be in general good health (as determined by the Investigator) based on screening assessments and medical history

Exclusion Criteria:

Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria:

  1. Body Mass Index (BMI) > 35
  2. Requires bilateral knee surgery
  3. Any of the following conditions:

    1. active joint infections
    2. is immunocompromised, has Sickle Cell disease, has a primary bone disease (e.g., Paget's disease) or disorders that may adversely affect the healing process, or is terminally ill
    3. inflammatory rheumatoid arthritis or other systemic inflammatory arthritis (i.e., gout)
    4. metastatic and/or neoplastic disease
    5. infectious, highly communicable diseases (e.g., active tuberculosis or active hepatitis)
    6. coagulation disorder or patient is receiving anti-coagulants
    7. documented evidence of a history (e.g. liver testing) of drug/alcohol abuse within the 12 months prior to screening for study entry
    8. diagnosed with a behavioral condition which could affect their ability to accurately comply with the study (e.g. developmental delay, attention deficit disorder, and autism)
  4. Any of the following conditions in the index limb or joint:

    1. Grade III or greater osteoarthritis as determined by AP radiograph (Kellgren-
    2. systemic steroid therapy or steroid intra-articular therapy within 4 weeks of enrollment into this study
    3. intra-articular viscosupplementation within 3 months of enrollment into this study
    4. osteomyelitis, septicemia, or other infections that may spread to other areas of the body
    5. fractures, osteocysts or osteolysis
    6. recurrent patellar instability (e.g., subluxation or dislocation)
    7. severe Varus or Valgus knee deformities
    8. tear of the lateral meniscus
    9. avascular necrosis
    10. synovial disorders (e.g., pigmented villanodular synovitis)
    11. previous total or partial meniscectomy
    12. requires reconstruction or replacement of medial or lateral meniscus
    13. knee instability, malalignment, or patellar tracking dysfunction
    14. prior treatment for cartilage repair, including but not limited to ACI, Mosaicplasty and/or marrow stimulation procedures
    15. prior knee tendon and/or ligament repair or patellar surgery within 6 months of enrollment into this study
  5. Any of the following conditions in the contralateral limb or joint:

    1. greater than minimal abnormality as shown by clinical exam and/or imaging
    2. scheduled or to be scheduled for surgery over the course of this study
    3. involvement causing abnormal ambulation and non-compliance with post-operative rehabilitation guideline
  6. The subject has implanted metallic devices (insulin pumps, nerve stimulators, etc), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing an MRI scan of the knee
  7. The subject has claustrophobia that would inhibit their ability to undergo an MRI scan of the index knee
  8. Receiving prescription narcotic pain medication for conditions unrelated to the index knee condition
  9. Cardiac pacemaker or other electronic implant(s)
  10. Pregnant and/or intending to become pregnant during this study period
  11. Participated in a clinical study within 6 months prior to surgery, or who is currently participating in another clinical study.
  12. Is a prisoner, or is known or suspected to be transient
  13. Is involved with Worker's Compensation unrelated to the index knee
  14. Is involved with health-related litigation

Intra-operative Exclusion Criteria

Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria:

  1. Has more than 1 chondral lesion requiring treatment
  2. Requires concomitant procedures (i.e., anterior cruciate ligament repair, high tibial osteotomy), excluding partial medial meniscectomy
  3. Has a medial meniscal tear not requiring treatment
  4. Has a medial meniscal tear requiring a procedure other than partial meniscectomy
  5. Has a lateral meniscal tear requiring treatment
  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 identifier: NCT01803880

Contact: Karlie Jackson 512-895-1257

United States, Arizona
Tucson Orthopaedic Institute Recruiting
Tucson, Arizona, United States, 85712
Contact: Jelena Candito, CCRC    520-784-6446   
Principal Investigator: Nebosja Skrepnik, MD, PhD         
Sub-Investigator: Scott Slagis, M.D.         
Sub-Investigator: Brian Nielsen, M.D.         
Sub-Investigator: Lawrence Housman, M.D.         
United States, Florida
Andrews Research and Education Foundation, Inc. Recruiting
Gulf Breeze, Florida, United States, 32561
Contact: Melissa Davis, RN    850-916-8591   
Contact: Cassidy Shefferd, MBA    850-916-8592   
Principal Investigator: Christopher O'Grady, MD         
Sub-Investigator: Roger Ostrander, MD         
Sub-Investigator: Charles Roth, MD         
United States, Indiana
Orthopaedic Research Foundation, Inc. Recruiting
Greenwood, Indiana, United States, 46143
Contact: Vicki Snodgrass-Miller, CCRC    317-884-5230   
Principal Investigator: Jack Farr II, MD         
Sub-Investigator: Matthew Lavery, M.D.         
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43221
Contact: Isac Kunnath    614-293-2410   
Principal Investigator: David Flanigan, MD         
United States, Pennsylvania
University Orthopedics Center Recruiting
State College, Pennsylvania, United States, 16801
Contact: Sue Jepson, RN    814-272-3751   
Contact: Jill Fremberg, MS    814-272-3691   
Principal Investigator: Douglas Roeshot, MD         
Sub-Investigator: Thomas J Ellis, DO         
Sub-Investigator: Paul Sensiba, MD         
Sub-Investigator: Chris S. McClellan, DO         
United States, Texas
Methodist Center For Orthopedic Surgery Active, not recruiting
Houston, Texas, United States, 77070
Basin Orthopedic Surgical Specialists Recruiting
Odessa, Texas, United States, 79761
Contact: Debbie Mossbarger, CCRP    432-853-5567   
Contact: Peggy Ludi, RN, CCRC    432-332-2663   
Principal Investigator: Steven C Riley, MD         
Sponsors and Collaborators
Smith & Nephew, Inc.
Principal Investigator: Jack Farr II, MD Orthopaedic Research Foundation, Inc.
  More Information

Responsible Party: Smith & Nephew, Inc. Identifier: NCT01803880     History of Changes
Other Study ID Numbers: SM-2012-02 
Study First Received: February 15, 2013
Last Updated: March 2, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Smith & Nephew, Inc.:
Articular cartilage
Cartilage lesion
Cartilage defect
MR imaging
Mechanical debridement
Mechanical shaver
Torn meniscus
Arthroscopic knee surgery
Damaged cartilage processed this record on May 25, 2016