Functional and Quality of Life Outcomes Following Viscosupplementation for Knee Osteoarthritis

January 24, 2014 updated by: University of Florida

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32607
        • UF&Shands Orthopaedics and Sports Medicine Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with symptomatic knee osteoarthritis.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 293-2009

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