MR Imaging of Knee Osteoarthritis and Acute Knee Injuries

NCT00504114 | Completed

• 1 other identifier: 2R01AR046905
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to use better magnetic resonance imaging (MRI) techniques to examine the knee and the bony and soft tissue changes so as to better predict the progression of osteoarthritis and acute knee injuries.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis, knee; anterior cruciate ligament; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Pathophysiology of bone marrow changes, relationship between trabecular bone and cartilage changes

  Baseline, 1 year, 2 year, 3 year

Secondary Outcomes (1)

• Evaluate T1rho relaxation methods and its' relation to cartilage loss

  Baseline, 1 year, 2 year, 3 year

Study Arms (5)

1

Healthy volunteers without knee pain.

2

Patients with mild arthritic symptoms and radiographic changes (Kellgren Lawrence score of 1, 2)

3

Patients with severe pain and functional limitations associated with knee arthritis (Kellgren Lawrence score of 3, 4).

Procedure: Total Knee Replacement

4

Patients with acute anterior cruciate ligament (ACL) injuries with associated osseous contusion.

Procedure: ACL Reconstruction Surgery

5

Patients with posttraumatic knee injury or degenerative condition and will have cartilage resurfacing procedures.

Procedure: Cartilage Resurfacing Surgery

Interventions

ACL Reconstruction Surgery PROCEDURE

4

Cartilage Resurfacing Surgery PROCEDURE

5

Total Knee Replacement PROCEDURE

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recruitment flyers are posted at different UCSF campuses and those staff and students. Patient eligibility will determined initially bye the referring orthopedist.

You may qualify if:

• Healthy volunteers will have had no previous knee symptoms or surgery
• Patients with mild arthritic symptoms and Kellgren Lawrence score of 2
• Patients with severe arthritic symptoms and Kellgren Lawrence score of 3, or 4
• Patients with acute ACL injury with associated bone contusion and bone edema
• Patients with posttraumatic knee injury or degenerative condition and will have cartilage resurfacing procedures
• Patient is willing to participate in the proposed study as evidenced by providing written informed consent.

You may not qualify if:

• Current use of an investigational drug
• Conditions other than OA which limit lower extremity function and mobility and/or would confound the evaluation of function (e.g., clinically significant spinal disc degeneration, painful or dysfunctional feet, peripheral vascular disease, lumbar radiculopathy or a stroke.)
• Patients with metallic fragments in the eyes, vascular clips, pacemakers, and other contraindications to MRI

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of California, San Francisco; MR Surbeck Laboratory of Advanced Imaging

San Francisco, California, 94158, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bone/cartilage tissue will be collected after the total knee replacement surgery. The tissue will further studied using advanced MR imaging techniques.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Sharmila Majumdar, Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2007
• First Posted: July 19, 2007
• Study Start: August 1, 2006
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 12, 2013

Record last verified: 2013-12

Locations

US (1)