We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mechanical vs. Radiofrequency-Based Debridement in the Treatment of Articular Cartilage Lesions (ACT)

This study has been terminated.
(Unable to meet enrollment goals)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01803880
First Posted: March 4, 2013
Last Update Posted: July 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Smith & Nephew, Inc.
  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 Device: RF-Based Debridement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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


Enrollment: 148
Study Start Date: March 2013
Study Completion Date: June 30, 2017
Primary Completion Date: June 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mechanical Debridement
Mechanical shaver removes areas of damaged tissue
Device: Mechanical Debridement
mechanical shaver that removes areas of damaged tissue
Other Name: Mechanical Shaver
Active Comparator: RF-based Debridement
Electrical energy removes areas of damaged tissue (Coblation®)
Device: RF-Based Debridement
Electrical energy that removes areas of damaged tissue (Coblation®)
Other Name: Paragon T2 ICW, FLOW 50 wand

Detailed Description:

This is a non-inferiority, prospective, double blinded, multi-center, randomized, controlled, adaptive study design with enrollment of 82 randomized subjects at up to 13 study sites. Study duration will be until the last subject enrolled reaches 104 weeks post-operative.

The study will be comprised of two parts:

Part I: Part I will require all Investigators perform 1 to 3 procedures using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Investigators must be qualified by training to perform procedures prior to use of either study device. This purpose of Part I will be to minimize variability with the recommended directions for use established in the instructions for use (IFU). Part I subjects will be followed per protocol follow-up requirements, and will be included in the safety population only. These subjects will be additive (to the safety population) to the 82 randomized subjects planned as part of the primary evaluation in Part II.

Part II: Part II will consist of 82 randomized subjects. Each Investigator may initiate enrollment of subjects in this part of the study following completion of Part I requirements. The Part II study implements a randomized adaptive study design, whereby an interim analysis will be conducted for sample size re-assessment. There is no intention of reducing the sample size as a result of this interim analysis; however, the sample size may be increased to either establish the non-inferiority and/or may be increased sufficiently to establish superiority depending on the results of the interim analysis.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803880


Locations
United States, Arizona
Tucson Orthopaedic Institute
Tucson, Arizona, United States, 85712
United States, Florida
Andrews Research and Education Foundation, Inc.
Gulf Breeze, Florida, United States, 32561
United States, Indiana
Orthopaedic Research Foundation, Inc.
Greenwood, Indiana, United States, 46143
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43221
United States, Pennsylvania
University Orthopedics Center
State College, Pennsylvania, United States, 16801
United States, Texas
Methodist Center For Orthopedic Surgery
Houston, Texas, United States, 77070
Basin Orthopedic Surgical Specialists
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
First Submitted: February 15, 2013
First Posted: March 4, 2013
Last Update Posted: July 7, 2017
Last Verified: July 2017

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