Knee OsteoarthritisNCT01478386
Effectiveness of a Knee Brace When Combined With Viscosupplementation in the Treatment of Knee Osteoarthritis
A study testing Orthovisc, DonJoy HA lite knee brace and Orthovisc injections and DonJoy HA lite knee brace in people with Knee Osteoarthritis, run by OAD Orthopaedics at 1 site in United States.
Trial summary
Hypothesis: Viscosupplementation when combined with an off-loading knee brace is more effective in treating the symptoms of knee OA then treating with viscosupplementation alone Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Orthovisc, DonJoy HA lite knee brace and Orthovisc injections and DonJoy HA lite knee brace
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects, over the age of 18, with a diagnosis of knee osteoarthritis which is confirmed by radiographs.
- Radiographs will be obtained and patients with mild to moderate knee osteoarthritis will qualify a subject for enrollment.
- Subjects will also have a documented varus deformity.
Who cannot join
- Subjects with severe arthritis as demonstrated by radiographs.
- In addition those subjects with a known or suspected joint infection and subjects who had undergone arthrocentesis and/or intra-articular injection within 3 months of the study will be excluded.
- Female patients who are pregnant or breast feeding will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trail to Assess the Effectiveness of an Off-Loading Knee Brace When Combined With Viscosupplementation in the Treatment of Knee Osteoarthritis
Hypothesis: Viscosupplementation when combined with an off-loading knee brace is more effective in treating the symptoms of knee OA then treating with viscosupplementation alone
Read the detailed description
A randomized prospective study to assess the effectiveness of treating knee osteoarthritis with either a series of three viscosupplementation injections, an off-loading knee brace, or a combination of viscosupplementation and an off-loading knee brace. The viscosupplementation and off-loading knee brace are being used in accordance with their FDA approval. Subjects will be randomized to 1 of 3 treatment groups. The control group will receive a series of weekly (3 consecutive weeks) intra-articular hyaluronic acid injections. The second group will receive a series of weekly (3 consecutive weeks) intra-articular hyaluronic acid injections and an off loading knee brace. The third group will use the off loading knee brace alone. Subjects will complete the WOMAC Osteoarthritis Questionnaire (pain, stiffness, function) and VAS pain scale (measuring pain on movement) at baseline, day 7, day 14, 6 weeks and 3 months. Subjects in group 2 and 3 will be given a brace diary to record compliance.
- Conditions
- Knee Osteoarthritis
- Being tested
- Orthovisc, DonJoy HA lite knee brace, Orthovisc injections and DonJoy HA lite knee brace
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrthoviscOther
Subjects will receive a series of three Orthovisc injections into their affected knee
DonJoy HA lite knee braceDevice
Subjects will be fitted and educated on using the DonJoy HA lite knee brace to treat their affected knee
Orthovisc injections and DonJoy HA lite knee braceDevice
Subjects will receive a series of three Orthovisc injections and be fitted and educated on using a DonJoy HA lite knee brace
| Study group | Role | What they receive |
|---|---|---|
| Viscosupplementation injections | Other | Control group will receive a series of three viscosupplementation injections into the affected knee Receives: Other: Orthovisc |
| Off-loading knee brace | Experimental | Not described Receives: Device: DonJoy HA lite knee brace |
| Viscosupplementation and knee brace | Experimental | Not described Receives: Device: Orthovisc injections and DonJoy HA lite knee brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in knee pain
The primary outcome measure will be a reduction in knee pain as measured by the VAS pain score. The secondary outcome measure will be an increase in function as measured by the WOMAC Osteoarthritis Questionnaire.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: The study was terminated due to poor enrollment
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.
- 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
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- OAD Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William R Sterba, MD, Principal investigator, OAD Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478386
- Sponsor's protocol ID
- Knee OA Treatments
- Status last verified
- Jul 2013
- First submitted
- 21 Nov 2011
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trail to Assess the Effectiveness of an Off-Loading Knee Brace When Combined With Viscosupplementation in the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01478386
- Acronym / sponsor ID
- Knee OA Treatments
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to poor enrollment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- OAD OrthopaedicsUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 23 Nov 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.
Hypothesis: Viscosupplementation when combined with an off-loading knee brace is more effective in treating the symptoms of knee OA then treating with viscosupplementation alone
Detailed description
A randomized prospective study to assess the effectiveness of treating knee osteoarthritis with either a series of three viscosupplementation injections, an off-loading knee brace, or a combination of viscosupplementation and an off-loading knee brace. The viscosupplementation and off-loading knee brace are being used in accordance with their FDA approval. Subjects will be randomized to 1 of 3 treatment groups. The control group will receive a series of weekly (3 consecutive weeks) intra-articular hyaluronic acid injections. The second group will receive a series of weekly (3 consecutive weeks) intra-articular hyaluronic acid injections and an off loading knee brace. The third group will use the off loading knee brace alone. Subjects will complete the WOMAC Osteoarthritis Questionnaire (pain, stiffness, function) and VAS pain scale (measuring pain on movement) at baseline, day 7, day 14, 6 weeks and 3 months. Subjects in group 2 and 3 will be given a brace diary to record compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Viscosupplementation injections | Other | Other: OrthoviscControl group will receive a series of three viscosupplementation injections into the affected knee |
| Off-loading knee brace | Experimental | Device: DonJoy HA lite knee brace |
| Viscosupplementation and knee brace | Experimental | Device: Orthovisc injections and DonJoy HA lite knee brace |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects, over the age of 18, with a diagnosis of knee osteoarthritis which is confirmed by radiographs.
- Radiographs will be obtained and patients with mild to moderate knee osteoarthritis will qualify a subject for enrollment.
- Subjects will also have a documented varus deformity.
Key exclusion criteria (3 listed)
- Subjects with severe arthritis as demonstrated by radiographs.
- In addition those subjects with a known or suspected joint infection and subjects who had undergone arthrocentesis and/or intra-articular injection within 3 months of the study will be excluded.
- Female patients who are pregnant or breast feeding will also be excluded.
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 |
|---|---|---|
| OrthoviscSubjects will receive a series of three Orthovisc injections into their affected knee | Other | Viscosupplementation injections |
| DonJoy HA lite knee braceSubjects will be fitted and educated on using the DonJoy HA lite knee brace to treat their affected knee | Device | Off-loading knee brace |
| Orthovisc injections and DonJoy HA lite knee braceSubjects will receive a series of three Orthovisc injections and be fitted and educated on using a DonJoy HA lite knee brace | Device | Viscosupplementation and knee brace |
Primary outcome
Reduction in knee pain
Time frame: 3 months
The primary outcome measure will be a reduction in knee pain as measured by the VAS pain score. The secondary outcome measure will be an increase in function as measured by the WOMAC Osteoarthritis Questionnaire.
Results and safety
The study was stopped early (reason given: The study was terminated due to poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2013.
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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.
William R Sterba, MD principal investigator
OAD Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthovisc, DonJoy HA lite knee brace and Orthovisc injections and DonJoy HA lite knee brace in people with Knee Osteoarthritis, run by OAD Orthopaedics 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 3 inclusion and 3 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 23 Jul 2013. 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: The study was terminated due to poor enrollment). 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?
Reduction in knee pain (time frame: 3 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 23 Jul 2013.