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Sponsored by: |
ArthroCare Corporation |
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Information provided by: | ArthroCare Corporation |
ClinicalTrials.gov Identifier: | NCT00613535 |
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 (MR), at the site of an ICRS Grade II or III (partial thickness) chondral tissue on the medial femoral condyle observed during arthroscopy 6 months earlier and treated using one of three standard clinical methods.
Condition | Intervention | Phase |
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Partial Meniscectomy Chondral Lesions |
Device: Mechanical Shaver Device: Paragon T2 |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study |
Official Title: | Magnetic Resonance Imaging and Clinical Outcomes After Three Different Treatments for ICRS Grade II or III Medial Femoral Condyle Chondral Tissue Concomitant With Partial Meniscectomy |
Estimated Enrollment: | 145 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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No chondral treatment: No Intervention
Chondral lesions left untreated during partial meniscectomy
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Mechanical Shaver: Active Comparator |
Device: Mechanical Shaver
Mechanical shaver will be used to remove large chondral flaps and loose fragments
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RF based chondroplasty: Active Comparator |
Device: Paragon T2
Use Paragon device to debride after removal of larger chondral lesion flaps with mechanical shaver.
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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) no chondral debridement; 2) chondral debridement using the mechanical shaver; and 3) mechanical shaver debridement along with RF-based chondroplasty. The secondary aim is to determine the association between imaging features and clinical outcomes.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:Screening
Arthroscopy Inclusion Criteria:
Exclusion Criteria: Screening
Arthroscopy Exclusion Criteria:
Contact: Deborah A. Tominack | 703-863-5007 | trialsva@erols.com |
Contact: Wendy Winters, BS | 408-735-6278 | wwinters@arthrocare.com |
United States, California | |
Kerlan Jobe Orthopaedic Foundation | Recruiting |
Los Angeles, California, United States, 90045 | |
Contact: Karen Mohr, Exc. Dir. 310-665-7129 Karenmohr@aol.com | |
Contact: Ralph Gambardella, MD 310-665-7258 rag@kerlanjobe.com | |
United States, Massachusetts | |
University of Mass. Memorial Medical Center | Not yet recruiting |
Worcester, Massachusetts, United States, 01685 | |
Contact: Dawn Bombard, RN, CCRC 508-426-2779 bombardd@ummhc.org | |
Contact: Brian Busconi, MD busconib@ummhc.org | |
United States, New York | |
University of Rochester Medical Center Department of Musculoskeletal Research | Recruiting |
Rochester, New York, United States, 14642 | |
Contact: Kelly Unsworth 585-275-1393 Kelly_Unsworth@URMC.Rochester.edu | |
Contact: Ilya Voloshin, MD Ilya_Voloshin@URMC.Rochester.edu | |
United States, Virginia | |
Commonwealth Orthopaedics | Recruiting |
Arlington, Virginia, United States, 22205 | |
Contact: Frank A Pettrone, M.D. (703) 525-6100 fpettrone@C-O-R.COM | |
Contact: Deborah Tominack | |
Sub-Investigator: Christopher Annunziata, MD | |
Sub-Investigator: Gordon Lee Avery, MD | |
Sub-Investigator: John Patrick McConnell, MD |
Principal Investigator: | Frank A. Pettrone, M.D. | Commonwealth Orthopaedics |
Responsible Party: | ArthroCare Corporation ( Wendy Winters ) |
Study ID Numbers: | A-706-DHH, 1093528 |
Study First Received: | January 31, 2008 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00613535 |
Health Authority: | United States: Institutional Review Board |
Chondral Lesion Partial Meniscectomy ICRS Grade II and III MR Imaging Mechanical Shaver Crepitus Stability Coblation Bipolar Radiofrequency |
Debridement Recurrent Knee Pain meniscectomy partial meniscectomy meniscus cartilage lesion articular cartilage lesion articular cartilage knee |
Pain Recurrence |