Trial record 14 of 29 for:    Open Studies | "Cartilage, Articular"

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
  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
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

Resource links provided by NLM:


Further study details as provided by ArthroCare Corporation:

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 Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mechanical Debridement (Mechanical Shaver)
Mechanical shaver that 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 that 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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. 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 ClinicalTrials.gov identifier: NCT01803880

Contacts
Contact: Heather Neill, RN, CCRP 512-358-5764 heather.neill@arthrocare.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, 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, Pennsylvania
University Orthopedics Center Recruiting
State College, Pennsylvania, United States, 16801
Contact: Sue Jepson, RN, BSN, CCRC    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         
United States, Texas
Methodist Center For Orthopedic Surgery Recruiting
Houston, Texas, United States, 77070
Contact: Todd Curry    512-638-0312    tcurry@hccrsite.com   
Contact: Tyler Miller, EMT, CRC    832-465-9251      
Principal Investigator: John P Seaberg, M.D.         
Sub-Investigator: Bruce Moseley, M.D.         
Basin Orthopedic Surgical Specialists Recruiting
Odessa, Texas, United States, 79761
Contact: Debbie Mossbarger, CCRP    432-853-5567    bossresearch@hotmail.com   
Contact: Peggy Ludi, RN, CCRC    432-332-2663    prludirn@gmail.com   
Principal Investigator: Steven C Riley, MD         
Sponsors and Collaborators
ArthroCare Corporation
Investigators
Principal Investigator: Jack Farr II, MD Orthopaedic Research Foundation, Inc.
  More Information

No publications provided

Responsible Party: ArthroCare Corporation
ClinicalTrials.gov Identifier: NCT01803880     History of Changes
Other Study ID Numbers: SM-2012-02
Study First Received: February 15, 2013
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by ArthroCare Corporation:
Articular cartilage
Cartilage lesion
Chondral lesion
Cartilage defect
Radiofrequency
Debridement
Cartilage
Coblation
Knee
Meniscus
Partial meniscectomy
MR imaging
Mechanical debridement
Mechanical shaver
Torn meniscus
Arthroscopic knee surgery
Damaged cartilage

ClinicalTrials.gov processed this record on September 18, 2014