NCT00613535

Knee Articular Cartilage Debridement in Conjunction With Partial Meniscectomy

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Torn Meniscus

Interventions

Type	Name	Description
DEVICE	Mechanical debridement	Mechanical shaver will be used to remove large chondral flaps and loose fragments
DEVICE	Paragon T2	Use Paragon device to debride after removal of larger chondral lesion flaps with mechanical shaver.
PROCEDURE	Lavage debridement	Remove loose chondral fragments
DEVICE	Mechanical Debridement	Use of a mechanical device such as a shaver, punch, or biter to remove large chondral flaps and loose fragments
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.

Timeline

• Start date: 2008-04-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2008-02-13
• Last updated: 2015-05-19

Locations

10 sites across 1 country: United States