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| Tracking Information | |||||||||
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| First Received Date ICMJE | January 31, 2008 | ||||||||
| Last Updated Date | October 21, 2009 | ||||||||
| Start Date ICMJE | April 2008 | ||||||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
In vivo magnetic resonance imaging (MRI) features of the femoral condyle chondral lesion [ Time Frame: 6 months after arthroscopy ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
• 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 ] | ||||||||
| Change History | Complete list of historical versions of study NCT00613535 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Knee Articular Cartilage Debridement in Conjunction With Partial Meniscectomy | ||||||||
| Official Title ICMJE | Magnetic Resonance Imaging and Clinical Outcomes After Three Different Treatments for Articular Cartilage Tissue Concomitant With Partial Meniscectomy | ||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | No Intervention: Articular cartilage defect left untreated by surgical tool during partial meniscectomy | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 145 | ||||||||
| Estimated Completion Date | December 2011 | ||||||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:Screening
Arthroscopy Inclusion Criteria:
Exclusion Criteria: Screening
Arthroscopy Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00613535 | ||||||||
| Responsible Party | Wendy Winters, ArthroCare Corporation | ||||||||
| Study ID Numbers ICMJE | A-706-DHH, 1093528 | ||||||||
| Study Sponsor ICMJE | ArthroCare Corporation | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | ArthroCare Corporation | ||||||||
| Verification Date | October 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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