Clinical trial NCT01447303: Functional and Quality of Life Outcomes Following Viscosupplementation for Knee Osteoarthritis
Official title: Functional and Quality of Life Outcomes Following Hyaluronic Acid (HA) Viscosupplementation for Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Knee Osteoarthritis
Keywords: knee
osteoarthritis
hyaluronic acid
viscosupplementation
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2011-10-06
Enrollment: 43
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic knee osteoarthritis.

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Decsribes any change from baseline over a period of 12 months; the study subjects will complete the (WOMAC) Index at baseline, 1, 3, 6 and 12 months following the viscosupplementation of the knee.
Secondary outcomes:
measure: Visual Analog Scale (VAS) documentation of the level of knee pain. The (VAS) will describe the change in the level of knee pain from baseline following viscosupplementation of the knee.
timeFrame: The study subjects will complete the (VAS) at baseline, 1, 3, 6 and 12 months following the viscosupplementation of the knee.
measure: Medical Outcomes Short Form (SF-36); completed to describe any change in perceived Quality of Life (QOL) from baseline following viscosupplementation of the knee.
timeFrame: The study subjects will complete the (SF-36) at baseline, 1, 3, 6 and 12 mos. following viscosupplementation of the knee.
measure: Chair Rise Time; describes any change from baseline in time to rise from a chair following viscosupplementation of the knee
timeFrame: The study subjects will complete the chair rise at baseline, 1, 3,6 and 12 mos. following viscosupplementation of the knee.
measure: Stair Climb Time; describes any change in the time from baseline to walk up a flight of 12 steps following viscosupplementation of the knee
timeFrame: The study subjects will complete the stair climb at baseline, 1, 3, 6 and 12 mos. following viscosupplementation of the knee.
measure: Six Minute Walk Test; describes any change from baseline in leg pain following viscosupplementation of the knee.
timeFrame: The study subjects will complete the six minute walk test at baseline, 1, 3, 6 and 12 mos. following viscosupplementation of the knee.
measure: Gait Analysis; describes any changes in gait from baseline following viscosupplementation of the knee.
timeFrame: The study subjects will complete the gait analysis at baseline, 1, 3, 6 and 12 mos. following viscosupplementation of the knee.
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF&Shands Orthopaedics and Sports Medicine Institute
state: Florida
Study officials:
affiliation: University of Florida Department of Orthopaedics and Rehabilitation
name: Heather K Vincent, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: