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Pilot Study of Therapy With Hylan G-F 20 Exercise Capacity

NCT01810848 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2016-03-29

No results posted yet for this study

Summary

Osteoarthritis of the knee is a degenerative joint disease that involves degradation of the joint. Symptoms include joint tenderness, pain, stiffness, locking, and occasionally an effusion. Over 40 million Americans also have cardiovascular disease in addition to their OA. Initiation and maintenance of even low-levels of physical activity is critical for management of cardiac risk. Patients with osteoarthritis have been shown to have poorer aerobic conditioning, lower daily physical activity levels and lower self-efficacy for exercise than non-OA cohorts.

It has been established that there exists a consistent gradient across activity groups indicating greater longevity and reduced risk of CHD, CVD, and stroke, in more active individuals. Available research suggests the greatest gains in cardiovascular fitness occur in moving a sedentary individual to even low levels of physical activity, and 12 weeks is enough to demonstrate change in the risk profile of at-risk individuals.

Finally, appropriate levels of aerobic and strength training have been shown to be beneficial in treatment of osteoarthritis of the knee. This study will evaluate the effectiveness of hylan G-F 20 (single injection preparation) in promoting greater levels of physical activity and fitness as measured by MET level compared to an exercise-only cohort; evaluating both the change in physical function as well as the cardiovascular risk profile. This is a randomized, single-blinded clinical trial comparing injection of the knee joint with Hylan GF-20 to sham procedure. Subjects will undergo a regular exercise program for 6 months following randomization.

Conditions

Interventions

DEVICE

Hylan G-F 20

Synvisc is an elastoviscous high molecular weight fluid which is injected into the knee joint ("intra-articular") for relief of pain from osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.

OTHER

Control

Control is puncture of the skin at the site of the knee.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • OhioHealth

    lead OTHER

Principal Investigators

  • Joseph J Ruane, DO · OhioHealth

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01810848 on ClinicalTrials.gov