Chondrocyte Maturation and Cartilage Loss Following Meniscal Injury - Full Text View

Sponsors and Collaborators:	University of Rochester National Institutes of Health (NIH) VirtualScopics, Inc.
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00595803

Purpose

The purpose of this study is to better understand the reason why people with injuries to their knee meniscus(cartilage) are at a higher risk for osteoarthritis later in life.

Condition
Meniscal Tear in Knee

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Chondrocyte Maturation and Cartilage Loss Following Meniscal Injury

Further study details as provided by University of Rochester:

Primary Outcome Measures:

Smurf2 expression in articular cartilage lesions (tested by immunohistochemical evaluation of debrided articular cartilage) [ Time Frame: Upon entry into study (at time of surgery) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression of cartilage loss by quantitative MRI [ Time Frame: 4 weeks & 3 years postoperatively ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

torn portion of meniscus, articular cartilage, joint fluid

Estimated Enrollment:	42
Study Start Date:	August 2006
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Participants requiring articular cartilage debridement during arthroscopy.
2 Participants with no significant articular cartilage lesions.

Detailed Description:

After arthorscopic meniscal surgery, some patients develop arthritis over the following one or two decades, while others do not. We have identified a gene which may become "turned on" in the cartilage of the knee joint after an injury and which may cause cartilage deterioration. The degree to which this happens in different individuals may determine who is at risk for arthritis after meniscal injury. Thus we hope to develop tests to identify individuals at high risk at the time of injury so that preventative meaures might be taken to decrease their chance of developing arthritis.

Patients who participate in the study will undergo standard arthroscopy procedures and will be followed for a longer time period than typical patients. Participants will have MRI scans a month after surgery and 3 years postoperatively, in addition to routine annual clinic visits and radiographs during the 3 year follow-up period.

Eligibility

Ages Eligible for Study:	20 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with an isolated medial meniscus tear presenting in the general practice of one the study investigators.

Criteria

Inclusion Criteria:

Isolated medial meniscus tear
Age range 20-50 years old
Male or female, any race
Tear type: mid to posterior horn, medical meniscus
Time from injury/onset of symptoms < 6 months
Failure of conservative management of symptoms
Mental status consistent with completing protocol

Exclusion Criteria:

Chronic symptoms > 6 months
Body Mass Index > 30
Avascular necrosis or osteochondritis dissecans by MRI
Peri-articular fracture by MRI
Presence of metal hardward about the knee
Severe claustrophobia
Knee ligament injury or instability of affected knee
Evidence of osteoarthritis on standing radiographs
Meniscal resection at arthroscopy at >50%
Inflammatory Joint Disease
History of allergy to MRI gadolinium contrast agent
Standard contra-indicationf to MRI
Varus knee deformity on plain standing AP radiograghs
Pregnancy
History of acute or chronic renal insufficiency of any severity (Creatinine levels >1.0 mg/dL; Glomerular Filtration Rate <60 mL/min/1.73m3)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595803

Contacts

Contact: Kelly Unsworth, MS

585-273-1465

Kelly_Unsworth@urmc.rochester.edu

Locations

United States, New York
University of Rochester	Recruiting
Rochester, New York, United States, 14642
Sub-Investigator: Michael Maloney, MD
Sub-Investigator: Barbara Gracious, MD
Sub-Investigator: Johnny Monu, MD

Sponsors and Collaborators

University of Rochester

National Institutes of Health (NIH)

VirtualScopics, Inc.

Investigators

Principal Investigator:

Randy Rosier, MD, PhD

University of Rochester

More Information

Responsible Party:	University of Rochester ( Randy Rosier, MD, PhD )
Study ID Numbers:	14578, P50AR054041
Study First Received:	January 7, 2008
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00595803
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Rochester:

Meniscus
Osteoarthritis
Smurf2

Study placed in the following topic categories:

Lacerations
Osteoarthritis

ClinicalTrials.gov processed this record on January 16, 2009