Knee OsteoarthritisNCT01447303
Functional and Quality of Life Outcomes Following Viscosupplementation for Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by University of Florida at 1 site in United States.
Trial summary
This study will compare changes in outcomes following viscosupplementation for knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Subject outcomes following viscosupplementation of the knee
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic knee osteoarthritis.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UF&Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, 32607
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Subject outcomes following viscosupplementation of the knee
- Keywords
- knee, osteoarthritis, hyaluronic acid, viscosupplementation
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subject outcomes following viscosupplementation of the kneeOther
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
| Study group | Role | What they receive |
|---|---|---|
| Outcomes following viscosupplemantation | Patients with documented knee osteoarthritis receiving viscosupplementation of the knee. Receives: Other: Subject outcomes following viscosupplementation of the knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (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.
Measured: 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 (SF-36) is a validated, internationally recognized standard instrument for assessing perceived (QOL) will be used to assess overall (QOL)
Measured: 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
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.
Measured: 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 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.
Measured: 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 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.
Measured: 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.
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.
Measured: The study subjects will complete the gait analysis at baseline, 1, 3, 6 and 12 mos. following viscosupplementation of the knee.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startAug 2009
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Inability to recruit subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather K Vincent, Ph.D., Principal investigator, University of Florida Department of Orthopaedics and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447303
- Sponsor's protocol ID
- 293-2009
- Status last verified
- Jan 2014
- First submitted
- 29 Sep 2011
- Last updated
- 27 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Quality of Life Outcomes Following Hyaluronic Acid (HA) Viscosupplementation for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01447303
- Acronym / sponsor ID
- 293-2009
- Conditions
- Knee Osteoarthritis
- Keywords
- knee, osteoarthritis, hyaluronic acid, viscosupplementation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inability to recruit subjects
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 6 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outcomes following viscosupplemantation | – | Other: Subject outcomes following viscosupplementation of the kneePatients with documented knee osteoarthritis receiving viscosupplementation of the knee. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic knee osteoarthritis.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subject outcomes following viscosupplementation of the kneeThe 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 | Other | Outcomes following viscosupplemantation |
Primary outcome
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.
6 secondary outcomes
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.
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.
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.
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.
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.
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.
Results and safety
The study was stopped early (reason given: Inability to recruit subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather K Vincent, Ph.D. principal investigator
University of Florida Department of Orthopaedics and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inability to recruit subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2014.