Status:
TERMINATED
Knee Articular Cartilage Debridement in Conjunction With Partial Meniscectomy
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Torn Meniscus
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
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...
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 les...
Eligibility Criteria
Inclusion
- 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
- Arthroscopic confirmation of ICRS Grade II or III chondral lesion on the medial or lateral femoral condyle
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00613535
Start Date
April 1 2008
End Date
June 1 2012
Last Update
May 19 2015
Active Locations (10)
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1
HOPE Research Institute
Phoenix, Arizona, United States, 85050
2
Kerlan Jobe Orthopaedic Foundation
Los Angeles, California, United States, 90045
3
JDP Medical Research
Aurora, Colorado, United States, 80014
4
Colorado Orthopedic Consultants, P.C.
Englewood, Colorado, United States, 80110