Meniscus TearNCT01256788
Post-op Treatment With Hyaluronic Acid Injections
A study testing Euflexxa and Saline in people with Meniscus Tear and Chondropathy/Degenerative Joint Disease (DJD), run by The Hawkins Foundation at 1 site in United States.
Trial summary
This study will look at patients with post-operative treatment of a meniscal tear or degenerative joint disease (degenerative arthritis). They will be randomized into one of three groups: Euflexxa injection, saline (placebo) injection, or no injection. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Meniscus Tear, Chondropathy/Degenerative Joint Disease (DJD)
- What is being tested?
- Euflexxa and Saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in post-op stage of treatment for meniscal tears or chondropathy/DJD
- Over 40 years of age
- A daily knee pain above 20mm on a 100mm visual analogue scale
Who cannot join
- Previous recipient of viscosupplementation injections
- Had rheumatoid arthritis or other inflammatory arthritis
- Had intra-articular steroid injections within the previous 2 months
- Invasive knee procedures within the past 6 months
- Contraindications to hyaluronate (an allergy)
- Medications that could interfere with the planned interventions
Trial locations and contacts
1 site in 1 country.
United States1 site
Steadman Hawkins Clinic of the Carolinas
Greenville, South Carolina, 29615
About this study
Official title: Prospective Randomized Study Evaluating Clinical Effectiveness of Post-op Treatment With Hyaluronic Acid Injections in Degenerative Joint Disease & Meniscal Tears
This study will look at patients with post-operative treatment of a meniscal tear or degenerative joint disease (degenerative arthritis). They will be randomized into one of three groups: Euflexxa injection, saline (placebo) injection, or no injection. Those who are randomized into the injection group will receive a series of three injections (one a week for 3 weeks), then a "booster" injection at 6 months post-op. Several questionnaires will be given after the first set of injections, then again at a one year follow-up.
The hypothesis is that patients receiving hyaluronic acid injections will have better pain and function scores as compared with placebo and no further treatment at all time points.
- Being tested
- Euflexxa, Saline
- Keywords
- viscosupplementation, meniscus tear, degenerative joint disease
- Medical subject headings
- Cartilage Diseases, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EuflexxaDevice
4 injections of 2ml of Euflexxa
SalineOther
4 injections of 3 ml of sterile saline
| Study group | Role | What they receive |
|---|---|---|
| Viscosupplementation | Experimental | Hyaluronic acid injection Receives: Device: Euflexxa |
| Saline injection | Placebo comparator | Not described Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tegner Activity Level Scale Score
The Tegner Scoring system is a numeric scale range from 1 to 10, with each value indicating the ability to perform a specific activity. The scoring system is ordinal in nature and reflects lower to higher levels of activity participation, with higher numbers indicating a higher level of function.
Measured: 1 yr postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Insurance now covers post-op HA injections, drastically decreasing enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Meniscus TearStudies 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
- Model description
- The two treatment groups were: 1. Received saline injection 2. Received viscosupplementation injection
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hawkins Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Thomas Pace, MD, Study chair, Greenville Hospital System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256788
- Sponsor's protocol ID
- Pro00007133
- Status last verified
- Dec 2018
- First submitted
- 6 Dec 2010
- Last updated
- 8 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Evaluating Clinical Effectiveness of Post-op Treatment With Hyaluronic Acid Injections in Degenerative Joint Disease & Meniscal Tears
- ClinicalTrials.gov ID
- NCT01256788
- Acronym / sponsor ID
- Pro00007133
- Keywords
- viscosupplementation, meniscus tear, degenerative joint disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insurance now covers post-op HA injections, drastically decreasing enrollment.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- The Hawkins FoundationUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Study start
- Sep 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 9 Dec 2010 (estimated)
- Results
- Posted 8 Jan 2019
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 look at patients with post-operative treatment of a meniscal tear or degenerative joint disease (degenerative arthritis). They will be randomized into one of three groups: Euflexxa injection, saline (placebo) injection, or no injection. Those who are randomized into the injection group will receive a series of three injections (one a week for 3 weeks), then a "booster" injection at 6 months post-op. Several questionnaires will be given after the first set of injections, then again at a one year follow-up.
The hypothesis is that patients receiving hyaluronic acid injections will have better pain and function scores as compared with placebo and no further treatment at all time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The two treatment groups were: 1. Received saline injection 2. Received viscosupplementation injection
| Arm | Type | Receives |
|---|---|---|
| Viscosupplementation | Experimental | Device: EuflexxaHyaluronic acid injection |
| Saline injection | Placebo comparator | Other: Saline |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients in post-op stage of treatment for meniscal tears or chondropathy/DJD
- Over 40 years of age
- A daily knee pain above 20mm on a 100mm visual analogue scale
Key exclusion criteria (6 listed)
- Previous recipient of viscosupplementation injections
- Had rheumatoid arthritis or other inflammatory arthritis
- Had intra-articular steroid injections within the previous 2 months
- Invasive knee procedures within the past 6 months
- Contraindications to hyaluronate (an allergy)
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 |
|---|---|---|
| Euflexxa4 injections of 2ml of Euflexxa | Device | Viscosupplementation |
| Saline4 injections of 3 ml of sterile saline | Other | Saline injection |
Primary outcome
Tegner Activity Level Scale Score
Time frame: 1 yr postop
The Tegner Scoring system is a numeric scale range from 1 to 10, with each value indicating the ability to perform a specific activity. The scoring system is ordinal in nature and reflects lower to higher levels of activity participation, with higher numbers indicating a higher level of function.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Thomas Pace, MD study chair
Greenville Hospital System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Euflexxa and Saline in people with Meniscus Tear and Chondropathy/Degenerative Joint Disease (DJD), run by The Hawkins Foundation 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 6 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 8 Jan 2019. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 8 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tegner Activity Level Scale Score (time frame: 1 yr postop). 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 8 Jan 2019.