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

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. Identifier: NCT00613535
Recruitment Status : Terminated (The correlation coefficient at the interim analysis with results for all three groups pooled, did not reach the level of statistical significance of (p<0.05).)
First Posted : February 13, 2008
Last Update Posted : May 19, 2015
Information provided by (Responsible Party):
Smith & Nephew, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Torn Meniscus Device: Mechanical debridement Device: Paragon T2 Procedure: Lavage debridement Device: Mechanical Debridement Device: RF- based Debridement Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Magnetic Resonance Imaging and Clinical Outcomes After Three Different Treatments for Articular Cartilage Lesions Concomitant With Partial Meniscectomy
Study Start Date : April 2008
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. In vivo magnetic resonance imaging (MRI) features of the femoral condyle chondral lesion [ Time Frame: 6 months after arthroscopy ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00613535

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
Smith & Nephew, Inc.
Principal Investigator: Frank A Pettrone, M.D. Commonwealth Orthopaedics


Responsible Party: Smith & Nephew, Inc. Identifier: NCT00613535     History of Changes
Other Study ID Numbers: A-706-DHH
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: May 19, 2015
Last Verified: May 2015

Keywords provided by Smith & Nephew, Inc.:
Partial Meniscectomy
Partial Thickness Knee Tear
MR Imaging
Mechanical Debridement
Bipolar Radiofrequency
Recurrent Knee Pain
cartilage lesion
articular cartilage lesion
articular cartilage