Functional and Quality of Life Outcomes Following Viscosupplementation for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Functional and Quality of Life Outcomes Following Hyaluronic Acid (HA) Viscosupplementation for Knee Osteoarthritis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01447303
• Other study ID #: 293-2009
• Status: Terminated
• Phase: N/A
• First received: September 29, 2011
• Last updated: January 24, 2014
• Start date: August 2009
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 85 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	UF&Shands Orthopaedics and Sports Medicine Institute	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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.	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.	No
Secondary	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 (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.	The study subjects will complete the (VAS) at baseline, 1, 3, 6 and 12 months following the viscosupplementation of the knee.	No
Secondary	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 (SF-36) is a validated, internationally recognized standard instrument for assessing perceived (QOL) will be used to assess overall (QOL)	The study subjects will complete the (SF-36) at baseline, 1, 3, 6 and 12 mos. following viscosupplementation of the knee.	No
Secondary	Chair Rise Time; describes any change from baseline in time to rise from a chair 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.	The study subjects will complete the chair rise at baseline, 1, 3,6 and 12 mos. following viscosupplementation of the knee.	No
Secondary	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 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.	The study subjects will complete the stair climb at baseline, 1, 3, 6 and 12 mos. following viscosupplementation of the knee.	No
Secondary	Six Minute Walk Test; describes any change from baseline in leg pain 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.	The study subjects will complete the six minute walk test at baseline, 1, 3, 6 and 12 mos. following viscosupplementation of the knee.	No
Secondary	Gait Analysis; describes any changes in gait from baseline 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.	The study subjects will complete the gait analysis at baseline, 1, 3, 6 and 12 mos. following viscosupplementation of the knee.	No