Functional and Quality of Life Outcomes Following Viscosupplementation for Knee Osteoarthritis

Terminated

• Conditions: Knee Osteoarthritis
• Interventions: Other: Subject outcomes following viscosupplementation of the knee

• Registration Number: NCT01447303
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2011-09-29
• Study First Submitted QC: 2011-10-04
• Study First Posted: 2011-10-06
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-24
• Last Update Posted: 2014-01-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Outcomes following viscosupplemantation	Subject outcomes following viscosupplementation of the knee	Patients with documented knee osteoarthritis receiving viscosupplementation of the knee.

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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.	The (WOMAC) Index is a multidimensional, self-administered health status instrument for patients with osteoarthritis of the hip or knee. The index is a disease-specific, purpose built, high performance instrument for evaluative research in osteoarthritis clinical trials.

Secondary Outcome Measures

Name	Time	Method
Six Minute Walk Test; describes any change from baseline in leg pain following viscosupplementation of the knee.	The study subjects will complete the six minute walk test at baseline, 1, 3, 6 and 12 mos. following viscosupplementation of the knee.	The study subjects will walk at a self-selected pace around a pre-measured loop for a period of six minutes. Leg pain symptoms and scores will be collected using the (VAS) scale at one minute intervals. Leg pain location and type will be noted using a leg pain diagram and a subjective list of terms to describe the pain.
Medical Outcomes Short Form (SF-36); completed to describe any change in perceived Quality of Life (QOL) from baseline following viscosupplementation of the knee.	The study subjects will complete the (SF-36) at baseline, 1, 3, 6 and 12 mos. following viscosupplementation of the knee.	The (SF-36) is a validated, internationally recognized standard instrument for assessing perceived (QOL) will be used to assess overall (QOL)
Chair Rise Time; describes any change from baseline in time to rise from a chair following viscosupplementation of the knee	The study subjects will complete the chair rise at baseline, 1, 3,6 and 12 mos. following viscosupplementation of the knee.	Chair rise time is measured as the time required to move from a sitting position to fully standing. The measure will be repeated three times with the fastest time being recorded.
Stair Climb Time; describes any change in the time from baseline to walk up a flight of 12 steps following viscosupplementation of the knee	The study subjects will complete the stair climb at baseline, 1, 3, 6 and 12 mos. following viscosupplementation of the knee.	The time to walk up one flight of stairs was measured by having the study subjects walk up one flight of stairs consisting of 12 steps as quickly as possible. This test will be repeated after a 2 to 3 minute rest, and the faster of the two trials will be used for data analysis.
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.	The study subjects will complete the (VAS) at baseline, 1, 3, 6 and 12 months following the viscosupplementation of the knee.	The (VAS) responses are expressed on a ten centimeter line, with 0 representing no pain and 10 cm representing the worst pain possible. The patient places a mark across the line representing where their perceived pain lies, from no pain to severe pain; measured at rest, standing and rising from a chair.
Gait Analysis; describes any changes in gait from baseline following viscosupplementation of the knee.	The study subjects will complete the gait analysis at baseline, 1, 3, 6 and 12 mos. following viscosupplementation of the knee.	The study subjects will walk across a 26 foot long portable walkway. The mat is filled with pressure sensors and the output is fed into a software program. The stride length and frequency, the motion of the center of mass moving over the mat and the foot pressures with the walking steps will be collected.

Trial Locations

Locations (1)

UF&Shands Orthopaedics and Sports Medicine Institute; 🇺🇸 Gainesville, Florida, United States