Functional and Quality of Life Outcomes Following Viscosupplementation for Knee Osteoarthritis

NCT01447303 | Terminated

• 1 other identifier: 293-2009
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Osteoarthritis

Keywords

knee; osteoarthritis; hyaluronic acid; viscosupplementation

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (6)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (1)

Outcomes following viscosupplemantation

Patients with documented knee osteoarthritis receiving viscosupplementation of the knee.

Other: Subject outcomes following viscosupplementation of the knee

Interventions

Subject outcomes following viscosupplementation of the knee 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

Outcomes following viscosupplemantation

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic knee osteoarthritis.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF&Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Heather K Vincent, Ph.D.

  University of Florida Department of Orthopaedics and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: October 6, 2011
• Study Start: August 1, 2009
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 27, 2014

Record last verified: 2014-01

Locations

US (1)