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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 December 2016 by Smith & Nephew, Inc.
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT01803880
First received: February 15, 2013
Last updated: December 9, 2016
Last verified: December 2016
  Purpose
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
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 ]
    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 ]
    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 ]
    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 ]
    Change in KOOS scores from baseline

  • Visual Analogue Scale, (VAS) Knee Pain [ Time Frame: Day 10, week 6, 12, 24, 36, 52 and 104 ]
    the change from baseline

  • SF-12 [ Time Frame: Weeks 6, 12, 24, 36, 52 and 104 ]
    Change in SF-12 scores from baseline

  • EQ-5D-5L [ Time Frame: Day 10, weeks 6, 12, 24, 36, 52 and 104 ]
    Change in EQ-5D-5L scores from baseline

  • Magnetic Resonance Imaging (MRI) [ Time Frame: Day 10, weeks 52 and 104 ]
    MRI assessments at Day 10, Weeks 52 and 104

  • Subject Satisfaction [ Time Frame: Weeks 52 and 104 ]
    Subject Satisfaction at Weeks 52 and 104


Estimated Enrollment: 106
Study Start Date: March 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (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, FLOW 50 wand

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. MRI within 9 months of enrollment into this study confirming presence of a medial femoral chondral lesion and medial meniscal tear requiring a partial meniscectomy (as determined by the Investigator)
  4. Must present with pain in the index knee of moderate or severe (> 30 mm) as measured by the VAS
  5. Must be able to understand English (written and oral)
  6. 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
  7. Must be in general good health (as determined by the Investigator) based on screening assessments and medical history

Intra-operative Inclusion Criteria

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

1. 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 2 with widely displaceable fibrillation or flaps or Grade 3A,
  3. < 4cm2 in size

Exclusion Criteria

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

  1. Body Mass Index (BMI) > 40 or index joint pain is due to BMI (as determined by Investigator)
  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 12 months of enrollment into this study
    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-Lawrence classification)
    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 (as determined by Investigator)
    8. symptomatic 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 30 days of enrollment into this study, 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 ClinicalTrials.gov identifier: NCT01803880

Contacts
Contact: Karlie Jackson 512-895-1257 karlie.jackson@smith-nephew.com

Locations
United States, Arizona
Tucson Orthopaedic Institute Recruiting
Tucson, Arizona, United States, 85712
Contact: Jelena Candito, CCRC    520-784-6446    jcandito@tucsonortho.com   
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: Laura Schubert, RN    850-916-8590    laura.schubert@andrewsref.org   
Contact: Cassidy Shefferd, MBA    850-916-8592    cassidy.shefferd@andrewsref.org   
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    vsmiller@orthoindy.com   
Principal Investigator: Jack Farr II, MD         
Sub-Investigator: Matthew Lavery, M.D.         
United States, Michigan
William Beaumont Hospital Not yet recruiting
Royal Oak, Michigan, United States, 48073
Contact: Karen Sherer, RN    248-551-1464    Karen.Sherer@beaumont.org   
Principal Investigator: James Bicos, MD         
Sub-Investigator: Joe Guettler, MD         
United States, New York
University of Rochester Medical Center Not yet recruiting
Rochester, New York, United States, 14618
Contact: Kaili Pecorella    585-341-9305    kaili_pecorella@URMC.Rochester.edu   
Contact: Allison McIntyre, MPH    585-341-9304    AllisonW_Mcintyre@URMC.Rochester.edu   
Principal Investigator: Ilya Voloshin, MD         
Sub-Investigator: Brian Giordano, MD         
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43221
Contact: Jordan Brauning    614-293-2761    Jordan.Brauning@osumc.edu   
Contact: Angela Pedroza, MPH    614-293-7952    Angela.Pedroza@osumc.edu   
Principal Investigator: David Flanigan, MD         
Sub-Investigator: Christopher Kaeding, MD         
Sub-Investigator: Robert Magnussen, MD         
United States, Pennsylvania
University Orthopedics Center Recruiting
State College, Pennsylvania, United States, 16801
Contact: Sue Jepson, RN    814-272-3751    sjepson@uoc.com   
Contact: Jill Fremberg, MS    814-272-3691    jfremberg@uoc.com   
Principal Investigator: Douglas Roeshot, MD         
Sub-Investigator: Thomas J Ellis, DO         
Sub-Investigator: Paul Sensiba, MD         
Sub-Investigator: Chris S. McClellan, DO         
Sub-Investigator: William Tyndall, MD         
Sub-Investigator: Robert Singer, DO         
Sub-Investigator: Joshua Port, MD         
Sub-Investigator: Ed Rogusky, MD         
United States, Texas
Methodist Center For Orthopedic Surgery Completed
Houston, Texas, United States, 77070
Basin Orthopedic Surgical Specialists Completed
Odessa, Texas, United States, 79761
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
Principal Investigator: Jack Farr II, MD Orthopaedic Research Foundation, Inc.
  More Information

Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT01803880     History of Changes
Other Study ID Numbers: SM-2012-02 
Study First Received: February 15, 2013
Last Updated: December 9, 2016

Keywords provided by Smith & Nephew, Inc.:
Articular cartilage
Cartilage lesion
Cartilage defect
Radiofrequency
Debridement
Cartilage
Coblation
Knee
Meniscus
Meniscectomy
MR imaging
Mechanical debridement
Mechanical shaver
Torn meniscus
Arthroscopic knee surgery
Damaged cartilage

ClinicalTrials.gov processed this record on February 20, 2017