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Knee Articular Cartilage Debridement in Conjunction With Partial Meniscectomy (MILE)
This study is currently recruiting participants.
Study NCT00613535   Information provided by ArthroCare Corporation
First Received: January 31, 2008   Last Updated: October 21, 2009   History of Changes

January 31, 2008
October 21, 2009
April 2008
June 2011   (final data collection date for primary outcome measure)
In vivo magnetic resonance imaging (MRI) features of the femoral condyle chondral lesion [ Time Frame: 6 months after arthroscopy ] [ Designated as safety issue: No ]
• In vivo magnetic resonance imaging (MRI) features of the medial femoral condyle chondral lesion [ Time Frame: 6 months after arthroscopy ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00613535 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
Knee Articular Cartilage Debridement in Conjunction With Partial Meniscectomy
Magnetic Resonance Imaging and Clinical Outcomes After Three Different Treatments for Articular Cartilage Tissue Concomitant With Partial Meniscectomy

The purpose of this post-marketing surveillance study is to determine the proportion of study participants who demonstrate tissue stability, as seen using magnetic resonance imaging (MRI), at the site of partial thickness articular cartilage defect on the femoral condyle observed during arthroscopy 6 months earlier and treated using one of three standard clinical methods.

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.

Phase IV
Interventional
Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
  • Partial Meniscectomy
  • Articular Cartilage Defect
  • Device: Mechanical Shaver
  • Device: Paragon T2
No Intervention: Articular cartilage defect left untreated by surgical tool during partial meniscectomy

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
145
December 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:Screening

  • Age between 18 and 60 years
  • BMI <35
  • Meniscal tear (medial or lateral) diagnosed by H+P exam and/or imaging
  • Minimal abnormality of opposite knee as shown by clinical exam and/or imaging
  • Candidate for unilateral arthroscopic treatment of the knee
  • Visual Analog Scale (VAS) score of 3 or greater in the knee to be treated (index knee)
  • 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 femoral condyle

Exclusion Criteria: Screening

  • Knee instability, malalignment, or patella tracking dysfunction
  • Joint space narrowing as seen by AP xray
  • Varus (>10 degrees) or Valgus (>15 degrees) knee deformities as seen by AP xray
  • Inflammatory rheumatoid arthritis or other systemic inflammatory arthritis
  • Previous total meniscectomy
  • Previous surgical treatment of index knee by arthroscopy within 2 years of enrollment into the study
  • 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
  • Presence of avascular necrosis
  • Presence of fractures, osteocysts or osteolysis
  • 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 6 months of enrollment into this study
  • Receiving pain medication for other condition unrelated to knee injury
  • Contralateral knee involvement causing abnormal ambulation and non-compliance with rehabilitation
  • Pregnant or suspected pregnant

Arthroscopy Exclusion Criteria:

  • Grade IV chondromalacia
  • ACL tear on the index knee
  • Osteochondritis dissecans (OCD)
Both
18 Years to 60 Years
Yes
Contact: Deborah A. Tominack 703-863-5007 trialsva@erols.com
Contact: Wendy Winters, BS 408-735-6278 wwinters@arthrocare.com
United States
 
NCT00613535
Wendy Winters, ArthroCare Corporation
A-706-DHH, 1093528
ArthroCare Corporation
 
Principal Investigator: Frank A. Pettrone, M.D. Commonwealth Orthopaedics
ArthroCare Corporation
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP