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

May 18, 2015 updated by: Smith & Nephew, Inc.

Magnetic Resonance Imaging and Clinical Outcomes After Three Different Treatments for Articular Cartilage Lesions Concomitant With Partial Meniscectomy

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

165

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • Hope Research Institute
    • California
      • Los Angeles, California, United States, 90045
        • Kerlan Jobe Orthopaedic Foundation
    • Colorado
      • Aurora, Colorado, United States, 80014
        • JDP Medical Research
      • Englewood, Colorado, United States, 80110
        • Colorado Orthopedic Consultants, P.C.
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Shrock Orthopedic Research, LLC
    • Massachusetts
      • Worcester, Massachusetts, United States, 01685
        • University of Mass. Memorial Medical Center
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center Department of Musculoskeletal Research
    • Texas
      • Odessa, Texas, United States, 79761
        • Basin Orthopedic Surgical Specialists
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Commonwealth Orthopaedics
      • Arlington, Virginia, United States, 22206
        • Anderson Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In vivo magnetic resonance imaging (MRI) features of the femoral condyle chondral lesion
Time Frame: 6 months after arthroscopy
6 months after arthroscopy

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smith & Nephew, Inc.

Investigators

  • Principal Investigator: Frank A Pettrone, M.D., Commonwealth Orthopaedics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

January 31, 2008

First Submitted That Met QC Criteria

February 12, 2008

First Posted (Estimate)

February 13, 2008

Study Record Updates

Last Update Posted (Estimate)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A-706-DHH
  • 1093528

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Torn Meniscus

Clinical Trials on Lavage debridement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe