Knee Articular Cartilage Debridement in Conjunction With Partial Meniscectomy (MILE)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
ArthroCare Corporation
ClinicalTrials.gov Identifier:
NCT00613535
First received: January 31, 2008
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

The aim of this study is to describe changes at the site of the study patient's articular cartilage lesion on the femoral condyle with multiple magnetic resonance imaging (MRI) outcomes 6 months after treatment using one of three standard surgical treatment methods: 1) lavage debridement; 2) mechanical debridement; 3) mechanical and radiofrequency-based debridement.


Condition Intervention Phase
Torn Meniscus
Articular Cartilage Defect
Device: Mechanical debridement
Device: Paragon T2
Procedure: Lavage debridement
Device: Mechanical Debridement
Device: RF- based Debridement
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Magnetic Resonance Imaging and Clinical Outcomes After Three Different Treatments for Articular Cartilage Lesions Concomitant With Partial Meniscectomy

Resource links provided by NLM:


Further study details as provided by ArthroCare Corporation:

Primary Outcome Measures:
  • In vivo magnetic resonance imaging (MRI) features of the femoral condyle chondral lesion [ Time Frame: 6 months after arthroscopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether recovery from recurrent pain, effusion, localized mechanical symptoms, and quality of life are equivalent for treatment groups [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Enrollment: 165
Study Start Date: April 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lavage debridement to remove loose fragments
Articular cartilage defect left untreated by surgical tool during partial meniscectomy
Procedure: Lavage debridement
Remove loose chondral fragments
Active Comparator: Mechanical Debridement
Remove large chondral flaps and loose fragments
Device: Mechanical debridement
Mechanical shaver will be used to remove large chondral flaps and loose fragments
Device: Mechanical Debridement
Use of a mechanical device such as a shaver, punch, or biter to remove large chondral flaps and loose fragments
Active Comparator: RF based Debridement
Debridement to remove loose fragments followed by use of Paragon T-2 RF wand to smooth the base of the shoulder of the tear
Device: Paragon T2
Use Paragon device to debride after removal of larger chondral lesion flaps with mechanical shaver.
Device: RF- based Debridement
Use of debridement device to remove large fragments followed by use of RF-based debridement to smooth the base of the shoulder of the tear.

Detailed Description:

Fibrillated articular cartilage are commonly detected during arthroscopy when treating knee pathologies such as a torn meniscus or a damaged anterior cruciate ligament (ACL). The severity of these lesions is graded using a scheme such as the International Cartilage Research Society (ICRS) classification system. Grade I lesions are often left untreated, while Grade IV lesions require dedicated surgical intervention. Grade II and III lesions are frequently treated when they are encountered arthroscopically.

Currently, it is not known whether treatment of fibrillated articular cartilage is beneficial or whether one procedure is superior to another. Magnetic resonance imaging is the best technique currently available for non-invasive assessment of chondral lesions. The primary aim of the proposed study is to compare post-procedure MR imaging characteristics of fibrillated articular cartilage treated using one of the three standard of care measures: 1) Washing of the knee joint with saline solution to clear blood, fluid or loose tissue (also known as lavage); 2) Lavage in addition to mechanical shaver (a manual surgical tool used by the study doctor); and 3)Lavage in addition to the Paragon device (RF-based microdebridement), which may also be used with a mechanical (or manual) surgical tool. The secondary aim is to determine the association between imaging features and clinical outcomes.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Screening

  • Age between 18 and 60 years
  • BMI <35
  • Meniscal tear (medial or lateral) diagnosed by H+P exam and/or imaging in the index knee
  • No severe joint space narrowing (IKDC Classification) seen on weight-bearing AP X-ray in the index knee
  • No avascular necrosis in the index knee as evidenced by preop MRI obtained within 6 months prior to randomization
  • No Varus (>10 degrees) or Valgus (>15 degrees)knee deformities as seen by AP X-ray in the index knee
  • Minimal or no abnormality of contralateral knee as shown by clinical exam and/or imaging
  • Candidate for unilateral arthroscopic treatment of the knee
  • Visual Analog Scale (VAS) pain score of 30 mm or greater in the index knee at the time of screening
  • Must be able to undergo MRI at required time points per appendix D
  • Physically and mentally willing and able to comply with study requirements
  • Must be willing and able to follow the standardized rehabilitation protocol (Appendix C)
  • Subject must sign IRB approved informed consent form

Arthroscopy Inclusion Criteria:

  • Arthroscopic confirmation of ICRS Grade II or III chondral lesion on the medial or lateral femoral condyle

Exclusion Criteria: Screening

  • Knee instability, malalignment, or patellar tracking dysfunction in the index knee
  • Inflammatory rheumatoid arthritis or other systemic inflammatory arthritis in the index knee or contralateral knee
  • Previous total meniscectomy in the index knee
  • Previous surgical treatment of the index knee by arthroscopy less than 2 years prior to treatment by this study
  • Previous total meniscectomy
  • Previous knee tendon and/or ligament repair or patellar surgery of index knee
  • Previous microfracture or bone marrow stimulation of the index knee
  • Previous unsuccessful osteotomy in the index knee
  • Presence of fractures, osteocysts or osteolysis in the index knee
  • Presence of osteoarthritis in the index knee
  • Pre-existent osteoarthritis of weight-bearing joints (e.g. hips or contralateral knee) that adversely affects gait
  • Participation in another clinical study
  • Terminally ill
  • Drug therapy for the index knee with systemic steroid therapy, steroid intra-articular therapy or intra-articular hyaluronic acid therapy within 2 months of enrollment into this study
  • Receiving narcotic pain medication by prescription for other conditions unrelated to knee injury
  • Contralateral knee involvement causing abnormal ambulation and non-compliance with rehabilitation
  • Pregnant or suspected pregnant
  • Coagulation disorder or patient is receiving anti-coagulants, which cannot be safely stopped for 14 days (7 days prior to surgery and 7 days post-surgery)

Arthroscopy Exclusion Criteria:

  • Presence of Grade IV chondromalacia anywhere in the index knee
  • ACL, PCL or MCL tear of the index knee
  • Osteochondritis dissecans (OCD)of the index knee
  • Meniscal tear requiring total meniscectomy
  • Evidence of osteoarthritis in the index knee
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00613535

Locations
United States, Arizona
HOPE Research Institute
Phoenix, Arizona, United States, 85050
United States, California
Kerlan Jobe Orthopaedic Foundation
Los Angeles, California, United States, 90045
United States, Colorado
JDP Medical Research
Aurora, Colorado, United States, 80014
Colorado Orthopedic Consultants, P.C.
Englewood, Colorado, United States, 80110
United States, Florida
Shrock Orthopedic Research, LLC
Fort Lauderdale, Florida, United States, 33316
United States, Massachusetts
University of Mass. Memorial Medical Center
Worcester, Massachusetts, United States, 01685
United States, New York
University of Rochester Medical Center Department of Musculoskeletal Research
Rochester, New York, United States, 14642
United States, Texas
Basin Orthopedic Surgical Specialists
Odessa, Texas, United States, 79761
United States, Virginia
Commonwealth Orthopaedics
Arlington, Virginia, United States, 22205
Anderson Clinic
Arlington, Virginia, United States, 22206
Sponsors and Collaborators
ArthroCare Corporation
Investigators
Principal Investigator: Frank A. Pettrone, M.D. Commonwealth Orthopaedics
  More Information

Additional Information:
Publications:

Responsible Party: ArthroCare Corporation
ClinicalTrials.gov Identifier: NCT00613535     History of Changes
Other Study ID Numbers: A-706-DHH, 1093528
Study First Received: January 31, 2008
Last Updated: July 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by ArthroCare Corporation:
Articular Cartilage Defect
Partial Meniscectomy
Partial Thickness Knee Tear
MR Imaging
Mechanical Debridement
Crepitus
Stability
Coblation
Bipolar Radiofrequency
Debridement
Recurrent Knee Pain
meniscectomy
partial meniscectomy
meniscus
cartilage lesion
articular cartilage lesion
articular cartilage
knee

ClinicalTrials.gov processed this record on April 22, 2014