Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-04-07 @ 5:20 PM
Study NCT ID:
NCT00613535
Status:
TERMINATED
Last Update Posted:
2015-05-19
First Post:
2008-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Knee Articular Cartilage Debridement in Conjunction With Partial Meniscectomy
Sponsor:
Smith & Nephew, Inc.
Organization:
Study Overview
Official Title:
Magnetic Resonance Imaging and Clinical Outcomes After Three Different Treatments for Articular Cartilage Lesions Concomitant With Partial Meniscectomy
Status:
TERMINATED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The correlation coefficient at the interim analysis with results for all three groups pooled, did not reach the level of statistical significance of (p\<0.05).
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MILE
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 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1093528 | None | None | View |