Loaded and Unloaded Magnetic Resonance (MR) Imaging of Meniscus-Cartilage-Trabecular Bone in Osteoarthritis

NCT01919736 | Completed

• 1 other identifier: CLOC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this project is to determine the effects of gait-retraining on articular cartilage composition, gait mechanics, pain and function in persons with mild to moderate knee osteoarthritis (OA).

Conditions

Knee Osteoarthritis

Keywords

knee OA

Outcome Measures

Primary Outcomes (1)

• Effects of moderate versus mild gait retraining on pain, function,and kinematics and kinetics during gait and stair climing in persons with symptomatic knee OA

  Everybody walks a little different. Some people walk with their toes pointed outwards (duck-footed) and other with their toes pointed straight or even inward(pigeon-toed). We will work with participants to teach you how to walk with slightly different toe angle. Participants will be randomly assign to each group and will be taught on this new walking pattern. Gait modification is a non-surgical treatment that can reduce the KAM (knee adduction moment). Changes to foot progression angle, tibia angle, hip adduction/internal rotation and trunk sway can reduce the KAM from baseline. Modifications involving simultaneous changes to multiple gait parameters have also been shown to reduce KAM.

  up to 6 months

Study Arms (2)

Moderate gait retraining

ACTIVE COMPARATOR

a moderate 7 degree toe-in modification

Behavioral: Gait Retraining

Mild gait retraining

ACTIVE COMPARATOR

A 2 degree toe-in gait retraining

Behavioral: Gait Retraining

Interventions

Gait Retraining BEHAVIORAL

Mild gait retraining; Moderate gait retraining

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• At least 35 years of age
• Mild OA patients with arthritic knee symptoms and KL score of 1-2
• Severe OA patients with arthritic knee symptoms and KL score of 3-4
• Knee symptoms in OA patients is defined as pain, aching, or stiffness on most days of a month during the past year or use of medication for treatment of knee pain on most days of a month during the past year
• self reported knee pain (defined as medial compartment knee pain at least 1 day per week during each of the 6 weeks prior to participation) and at least 3 of the following 6 clinical indicators: Age\>50 years; morning stiffness\<30 minutes duration; crepitus on active motion; tenderness of the bony margins of the knee joint; bony enlargement at the knee; and lack of palpable warmth of the synovium

You may not qualify if:

• current use of 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, trochanteric bursitis, hip pain, lumbar pain)
• Patients with metallic fragments in the eyes, vascular clips, pacemakers, and other contraindications to MRI
• History of joint replacement, intra-articular fracture, osteotomy, arthroplasty or meniscectomy of the signal knee
• History of other disease that may involve the study joint including systemic inflammatory disease, crystalline disease, knee infection of the signal knee, avascular necrosis, Paget's disease or tumors
• Self reported heart condition that limits any daily physical activity
• Patients who are pregnant

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

China Basin Imaging Center

San Francisco, California, 94107, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Sharmila Majumdar, PhD

  UCSF, Department of Radiology and Biomedical Imaging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: August 9, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 18, 2019

Record last verified: 2019-11

Locations

US (1)