Functional and Quality of Life Outcomes Following Viscosupplementation for Knee Osteoarthritis

This study has been terminated.
(Inability to recruit subjects)
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01447303
First received: September 29, 2011
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Knee Osteoarthritis
Other: Subject outcomes following viscosupplementation of the knee

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Functional and Quality of Life Outcomes Following Hyaluronic Acid (HA) Viscosupplementation for Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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:
  • 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. [ Time Frame: The study subjects will complete the (VAS) at baseline, 1, 3, 6 and 12 months following the viscosupplementation of the knee. ] [ Designated as safety issue: No ]
    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.

  • Medical Outcomes Short Form (SF-36); completed to describe any change in perceived Quality of Life (QOL) from baseline following viscosupplementation of the knee. [ Time Frame: The study subjects will complete the (SF-36) at baseline, 1, 3, 6 and 12 mos. following viscosupplementation of the knee. ] [ Designated as safety issue: No ]
    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 [ Time Frame: The study subjects will complete the chair rise at baseline, 1, 3,6 and 12 mos. following viscosupplementation of the knee. ] [ Designated as safety issue: No ]
    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 [ Time Frame: The study subjects will complete the stair climb at baseline, 1, 3, 6 and 12 mos. following viscosupplementation of the knee. ] [ Designated as safety issue: No ]
    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.

  • Six Minute Walk Test; describes any change from baseline in leg pain following viscosupplementation of the knee. [ Time Frame: The study subjects will complete the six minute walk test at baseline, 1, 3, 6 and 12 mos. following viscosupplementation of the knee. ] [ Designated as safety issue: No ]
    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.

  • Gait Analysis; describes any changes in gait from baseline following viscosupplementation of the knee. [ Time Frame: The study subjects will complete the gait analysis at baseline, 1, 3, 6 and 12 mos. following viscosupplementation of the knee. ] [ Designated as safety issue: No ]
    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.


Enrollment: 43
Study Start Date: August 2009
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Outcomes following viscosupplemantation
Patients with documented knee osteoarthritis receiving viscosupplementation of the knee.
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

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

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with symptomatic knee osteoarthritis.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447303

Locations
United States, Florida
UF&Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, United States, 32607
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Heather K Vincent, Ph.D. University of Florida Department of Orthopaedics and Rehabilitation
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01447303     History of Changes
Other Study ID Numbers: 293-2009
Study First Received: September 29, 2011
Last Updated: January 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
knee
osteoarthritis
hyaluronic acid
viscosupplementation

Additional relevant MeSH terms:
Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on September 16, 2014