Functional and Quality of Life Outcomes Following Viscosupplementation for Knee Osteoarthritis

NCT ID: NCT01447303

Last Updated: 2014-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2013-11-30

Brief Summary

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This study will compare changes in outcomes following viscosupplementation for knee osteoarthritis.

Detailed Description

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The specific aims of this study are to compare the changes in knee pain symptoms, physical function, gait parameters and quality of life in persons with knee OA following a standard viscosupplementation injection series of hyaluronic acid (HA) over a one year period.

Conditions

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Knee Osteoarthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Outcomes following viscosupplemantation

Patients with documented knee osteoarthritis receiving viscosupplementation of the knee.

Subject outcomes following viscosupplementation of the knee

Intervention Type OTHER

The study subject outcomes (WOMAC, VAS, SF-36, Chair rise, Stair climb, Six minute walk and Gait analysis) measured at 1, 3, 6 and 12 months following viscosupplementation of the knee

Interventions

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Subject outcomes following viscosupplementation of the knee

The study subject outcomes (WOMAC, VAS, SF-36, Chair rise, Stair climb, Six minute walk and Gait analysis) measured at 1, 3, 6 and 12 months following viscosupplementation of the knee

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 21 years of age or older
* osteoarthritis degeneration, degenerative joint disease or degeneration
* fully cognizant of study procedures
* willing to carefully participate in all study processes and assessments

Exclusion Criteria

* less that 21 years of age
* allergic reactivity to hyaluronic acid
* current knee infection, infection around injection site or any skin disease
* pregnancy or lactation
* non-ambulatory
Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heather K Vincent, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida Department of Orthopaedics and Rehabilitation

Locations

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UF&Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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293-2009

Identifier Type: -

Identifier Source: org_study_id

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