Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Mechanical Debridement Versus Radiofrequency-Based Debridement to Treat Articular Cartilage Lesions With Partial Meniscectomy in the Knee (ACT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by ArthroCare Corporation
Sponsor:
Information provided by (Responsible Party):
ArthroCare Corporation
ClinicalTrials.gov Identifier:
NCT01803880
First received: February 15, 2013
Last updated: July 15, 2014
Last verified: July 2014

February 15, 2013
July 15, 2014
March 2013
March 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01803880 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Mechanical Debridement Versus Radiofrequency-Based Debridement to Treat Articular Cartilage Lesions With Partial Meniscectomy in the Knee (ACT)
A Prospective, Double Blinded, Multicenter, Randomized, Controlled Trial to Evaluate Mechanical Debridement vs. Radiofrequency-Based Debridement in the Treatment of Articular Cartilage Lesions

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Chondral Lesion Plus Partial Medial Meniscectomy
  • Device: Mechanical Debridement (Mechanical Shaver)
    mechanical shaver that removes areas of damaged tissue
    Other Name: Mechanical Shaver
  • Device: Radiofrequency-Based Debridement
    Electrical energy that removes areas of damaged tissue (Coblation®)
    Other Name: Paragon® T2™ ICW wand
  • Active Comparator: Mechanical Debridement (Mechanical Shaver)
    Mechanical shaver that removes areas of damaged tissue
    Intervention: Device: Mechanical Debridement (Mechanical Shaver)
  • Active Comparator: Radiofrequency-based Debridement
    Electrical energy that removes areas of damaged tissue (Coblation®)
    Intervention: Device: Radiofrequency-Based Debridement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
106
Not Provided
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Heather Neill, RN, CCRP 512-358-5764 heather.neill@arthrocare.com
United States
 
NCT01803880
SM-2012-02
Yes
ArthroCare Corporation
ArthroCare Corporation
Not Provided
Principal Investigator: Jack Farr II, MD Orthopaedic Research Foundation, Inc.
ArthroCare Corporation
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP