Knee OsteoarthritisEVOKENCT01210742
The Efficacy of Viscosupplementation for Early Knee Osteoarthritis
A study testing Synvisc One and Routine management in people with Knee Osteoarthritis, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Treatment for early osteoarthritis (OA) of the knee is an increasing problem yet much of the research into OA, to date, concentrates on predisposition, genetic and cellular aspects and the treatment of late stage disease (arthroplasty). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Synvisc One and Routine management
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2011to Oct 2013
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years
- Radiographic evidence of OA in the tibiofemoral compartment (minute or definite osteophytes and a measurable joint space)
- Pain on walking (Visual Analogue Scale 0-10). Minimum of 4 and maximum of 9.
- Oxford knee score (OKS) of above 12 but below 36 (0-48, 48 no problem)
- Pain score of 1, 2 or 3 on Q1 (pain) of OKS.
- Suitable for viscosupplementation
Who cannot join
- OKS of below 12 and above 36 (0-48, 48 no problem)
- Pain score of 0 or 4 on Q1 (pain) of OKS.
- Grade 3 or 4 patellofemoral degeneration (Kellgren-Lawrence classification).
- Grade 3 or 4 tibiofemoral degeneration (Kellgren-Lawrence classification).
- A clinically apparent tense effusion of the target knee.
- Significant valgus/varus deformities.
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- Ligamentous laxity or meniscal instability.
- Viscosupplementation history in any joint in the past 9 months.
- Previous surgery at the target knee in the past 6 months.
- Concomitant inflammatory disease (rheumatoid arthritis) or other condition that affects the joints.
- Use of prohibited medication/treatment for chronic pain.
- Pregnancy or new mothers who are breastfeeding.
- Systemic or intra-articular injection of corticosteroids in any joint within 3 months prior to screening.
- Obvious cartilage defects producing mechanical symptoms (i.e. locking).
- Listed for a knee replacement procedure for osteoarthritis of the knee.
- Have a history of failed conservative treatment (exercise therapy, physiotherapy).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Nuffield Orthopaedic Centre, Biomedical Research Unit (BRU)
Oxford, England, OX3 7LD
Kristina Knezevic, kristina.knezevic@ndorms.ox.ac.uk
About this study
Official title: The Efficacy of Hylan G-F 20 (Synvisc One) Injections in the Routine Management of Patients With Early Osteoarthritis of the Knee -a Randomised Controlled Trial (Pilot)
Treatment for early osteoarthritis (OA) of the knee is an increasing problem yet much of the research into OA, to date, concentrates on predisposition, genetic and cellular aspects and the treatment of late stage disease (arthroplasty). Clinicians reviewing patients with early OA have great difficulty in recommending an appropriate and efficacious intervention.
The first line of treatment for patients with early OA is exercise, self-management and weight loss. These tools are suggested to minimize the need for higher risk treatments such as non-steroidal antiinflammatory drugs (NSAIDs) and surgery. Viscosupplementation using intra-articular injections of hyaluronan (Synvisc One) is a relatively new treatment. To date, the ideal patient for viscosupplementation has yet to be defined. It is not known whether incorporation of viscosupplementation into the overall clinical management will have beneficial influence for patients with early OA of the knee.
Read more
This study will generate rigorous pilot data to assess the need and inform a larger randomized controlled trial (RCT) assessing the efficacy of viscosupplementation. The study will be a single blind randomised RCT. 60 patients with documented early OA will be randomised into one of two groups; Group V will undergo "one shot" viscosupplementation using Synvisc One in addition to routine physiotherapy management for knee OA. Group No V (control) will have no viscosupplementation but will undergo similar routine management including physiotherapy management for knee OA. Outcome measures will include walking pain (The Western Ontario and McMaster Universities Arthritis Index-WOMAC), the overall WOMAC score, Oxford Knee Score (OKS), American Knee Society score (AKS), complications, activity level and patient satisfaction. Health economics will also be evaluated. Measurements will be recorded pre-intervention and at six months following treatment.
The risks associated with viscosupplementation are minimal. Considering the limited resources currently available in health care, if the latter is shown to have higher effectiveness than physiotherapy alone, in addition to patient benefit, there will be important health economic implications.
- Conditions
- Knee Osteoarthritis
- Being tested
- Synvisc One, Routine management
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synvisc OneDevice
Single intra-articular injection of a 6 mL of Hylan G-F 20 at baseline
Routine managementOther
Routine non-operative management for knee OA (NICE guidelines)
| Study group | Role | What they receive |
|---|---|---|
| Viscosupplementation with routine management | Experimental | Not described Receives: Device: Synvisc One |
| Routine management | Active comparator | Routine management for knee OA (NICE guidelines) Receives: Other: Routine management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking pain
Measured: 6 months
Secondary outcomes (1)
Patient satisfaction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startMay 2011
- Primary completionJun 2013 (estimated)
- Study completionOct 2013 (estimated)
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 OxfordThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David J Beard, DPhil, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210742
- Sponsor's protocol ID
- 10/H0604/33
- Acronym
- EVOKE
- Status last verified
- Jun 2012
- First submitted
- 24 Sep 2010
- Last updated
- 18 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Hylan G-F 20 (Synvisc One) Injections in the Routine Management of Patients With Early Osteoarthritis of the Knee -a Randomised Controlled Trial (Pilot)
- ClinicalTrials.gov ID
- NCT01210742
- Acronym / sponsor ID
- EVOKE / 10/H0604/33
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 28 Sep 2010 (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.
Treatment for early osteoarthritis (OA) of the knee is an increasing problem yet much of the research into OA, to date, concentrates on predisposition, genetic and cellular aspects and the treatment of late stage disease (arthroplasty). Clinicians reviewing patients with early OA have great difficulty in recommending an appropriate and efficacious intervention.
The first line of treatment for patients with early OA is exercise, self-management and weight loss. These tools are suggested to minimize the need for higher risk treatments such as non-steroidal antiinflammatory drugs (NSAIDs) and surgery. Viscosupplementation using intra-articular injections of hyaluronan (Synvisc One) is a relatively new treatment. To date, the ideal patient for viscosupplementation has yet to be defined. It is not known whether incorporation of viscosupplementation into the overall clinical management will have beneficial influence for patients with early OA of the knee.
This study will generate rigorous pilot data to assess the need and inform a larger randomized controlled trial (RCT) assessing the efficacy of viscosupplementation. The study will be a single blind randomised RCT. 60 patients with documented early OA will be randomised into one of two groups; Group V will undergo "one shot" viscosupplementation using Synvisc One in addition to routine physiotherapy management for knee OA. Group No V (control) will have no viscosupplementation but will undergo similar routine management including physiotherapy management for knee OA. Outcome measures will include walking pain (The Western Ontario and McMaster Universities Arthritis Index-WOMAC), the overall WOMAC score, Oxford Knee Score (OKS), American Knee Society score (AKS), complications, activity level and patient satisfaction. Health economics will also be evaluated. Measurements will be recorded pre-intervention and at six months following treatment.
The risks associated with viscosupplementation are minimal. Considering the limited resources currently available in health care, if the latter is shown to have higher effectiveness than physiotherapy alone, in addition to patient benefit, there will be important health economic implications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Viscosupplementation with routine management | Experimental | Device: Synvisc One |
| Routine management | Active comparator | Other: Routine managementRoutine management for knee OA (NICE guidelines) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-70 years
- Radiographic evidence of OA in the tibiofemoral compartment (minute or definite osteophytes and a measurable joint space)
- Pain on walking (Visual Analogue Scale 0-10). Minimum of 4 and maximum of 9.
- Oxford knee score (OKS) of above 12 but below 36 (0-48, 48 no problem)
- Pain score of 1, 2 or 3 on Q1 (pain) of OKS.
Key exclusion criteria (16 listed)
- OKS of below 12 and above 36 (0-48, 48 no problem)
- Pain score of 0 or 4 on Q1 (pain) of OKS.
- Grade 3 or 4 patellofemoral degeneration (Kellgren-Lawrence classification).
- Grade 3 or 4 tibiofemoral degeneration (Kellgren-Lawrence classification).
- A clinically apparent tense effusion of the target knee.
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 |
|---|---|---|
| Synvisc OneSingle intra-articular injection of a 6 mL of Hylan G-F 20 at baseline | Device | Viscosupplementation with routine management |
| Routine managementRoutine non-operative management for knee OA (NICE guidelines) | Other | Routine management |
Primary outcome
Walking pain
Time frame: 6 months
1 secondary outcome
Patient satisfaction
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2012.
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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.
David J Beard, DPhil principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synvisc One and Routine management in people with Knee Osteoarthritis, run by University of Oxford at 1 site in United Kingdom.
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 6 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 18 Jun 2012. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristina Knezevic (+44 (0) 1865 227617, kristina.knezevic@ndorms.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking pain (time frame: 6 months). 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 18 Jun 2012.