OSTEOARTHRITISNCT00642382
Safety and Effectiveness of Agilus (Hyaluronic Acid) for Ankle Osteoarthritis
A study testing Agilus and Normal saline in people with OSTEOARTHRITIS, run by Cartiva, Inc. at 19 sites in United States.
Trial summary
The purpose of this study is to determine whether Agilus is safe and effective in the treatment of mild to moderate ankle osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- OSTEOARTHRITIS
- What is being tested?
- Agilus and Normal saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 19 sitesUnited States
- Study dates
- Apr 2008to Dec 2008
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Chronic, unilateral ankle pain(i.e., in only one ankle) for at least 6 months
- Diagnosis of ankle OA confirmed by radiographs (X-ray)and clinical exam
- Are normally active, without aid of mobility devices(such as crutch, walker or cane)
Who cannot join
- Have used oral steroids within 30 days (inhaled or topical steroids are acceptable)
- Have received intra-articular injections of hyaluronic acid in any joint in the last 9 months
- Have received steroid injections in any joint in last 3 months
- Have had previous surgery or arthroscopy on the affected ankle in the last 12 months
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Institute For Foot and Ankle Reconstruction At Mercy
Baltimore, Maryland, 21202
Greater Chesapeake Orthopaedic Association
Baltimore, Maryland, 21218
Brigham Foot and Ankle Center
Boston, Massachusetts, 02115
Orthocarolina
Charlotte, North Carolina, 28203
Rush University Medical Center
Chicago, Illinois, 60612
University of Missouri
Columbia, Missouri, 65212
Orthopedic Foot and Ankle Center
Columbus, Ohio, 43231
Minnesota Sports Medicine
Eden Prairie, Minnesota, 55344
Orthopaedic Associates of Hartford
Farmington, Connecticut, 06032
Orthopedic Associates of Grand Rapids
Grand Rapids, Michigan, 49525
Bone and Joint Clinic Houston
Houston, Texas, 77030
University of Texas Health Science Center At Houston
Houston, Texas, 77030
Desert Orthopaedic Center
Las Vegas, Nevada, 89121
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
UMDNJ
Newark, New Jersey, 07101
University of Pennsylvania
Philadelphia, Pennsylvania, 19106
Rhode Island Hospital
Providence, Rhode Island, 02903
University of Rochester
Rochester, New York, 14642
Pinnacle Research
Royal Palm Beach, Florida, 33411
About this study
Official title: Randomized, Double Blind,Saline-Controlled, Multi-Center, Prospective Study to Evaluate the Safety and Effectiveness of Carticept's Agilus Device for the Treatment of Ankle Osteoarthritis
The purpose of this study is to determine whether Agilus is safe and effective in the treatment of mild to moderate ankle osteoarthritis.
Read the detailed description
The objective of this study is to compare the safety and effectiveness of Agilus to a saline injection (control) in the treatment of mild to moderate ankle osteoarthritis. This is a multi-center, randomized, double blind, saline controlled, prospective study with two (2) treatment groups. The active group will receive one injection of Agilus per week for three consecutive weeks for a total of three injections. The control group will receive one injection of normal saline per week for three consecutive weeks for a total of three injections. Follow up visits will occur at 4 weeks, 12 weeks and 26 weeks following the third injection.
- Conditions
- OSTEOARTHRITIS
- Being tested
- Agilus, Normal saline
- Keywords
- Osteoarthritis, Hyaluronic Acid
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AgilusDevice
Also called Hyaluronic Acid
Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks.
Normal salineDevice
Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Agilus (Hyaluronic Acid) Receives: Device: Agilus |
| Control | Placebo comparator | Normal Saline Receives: Device: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Comparison Between the Agilus Injection and the Saline Control Injection Groups in the Proportion of Subjects Experiencing a Reduction in the Assessment of Pain Determined by the AOS Subscale for Pain.
Measured: At 4, 12 and 26 weeks post 3rd injection
Secondary outcomes (1)
Secondary Effectiveness Parameters That Will be Evaluated Include the Following That Evaluate Pain, Function, Subject's Global Assessment, Quality of Life and an Individual Subject Responder Analysis.
Measured: At 4, 12 and 26 weeks post 3rd injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2008
- Study completionDec 2008
Why it stopped: For safety concerns
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 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cartiva, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Judith Baumhauer, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642382
- Sponsor's protocol ID
- CMI-CP-Ankle-001
- Status last verified
- Jul 2017
- First submitted
- 19 Mar 2008
- Last updated
- 17 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind,Saline-Controlled, Multi-Center, Prospective Study to Evaluate the Safety and Effectiveness of Carticept's Agilus Device for the Treatment of Ankle Osteoarthritis
- ClinicalTrials.gov ID
- NCT00642382
- Acronym / sponsor ID
- CMI-CP-Ankle-001
- Conditions
- OSTEOARTHRITIS
- Keywords
- Osteoarthritis, Hyaluronic Acid
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: For safety concerns
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Cartiva, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 25 Mar 2008 (estimated)
- Results
- Posted 17 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Agilus is safe and effective in the treatment of mild to moderate ankle osteoarthritis.
Detailed description
The objective of this study is to compare the safety and effectiveness of Agilus to a saline injection (control) in the treatment of mild to moderate ankle osteoarthritis. This is a multi-center, randomized, double blind, saline controlled, prospective study with two (2) treatment groups. The active group will receive one injection of Agilus per week for three consecutive weeks for a total of three injections. The control group will receive one injection of normal saline per week for three consecutive weeks for a total of three injections. Follow up visits will occur at 4 weeks, 12 weeks and 26 weeks following the third injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: AgilusAgilus (Hyaluronic Acid) |
| Control | Placebo comparator | Device: Normal salineNormal Saline |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Chronic, unilateral ankle pain(i.e., in only one ankle) for at least 6 months
- Diagnosis of ankle OA confirmed by radiographs (X-ray)and clinical exam
- Are normally active, without aid of mobility devices(such as crutch, walker or cane)
Key exclusion criteria (4 listed)
- Have used oral steroids within 30 days (inhaled or topical steroids are acceptable)
- Have received intra-articular injections of hyaluronic acid in any joint in the last 9 months
- Have received steroid injections in any joint in last 3 months
- Have had previous surgery or arthroscopy on the affected ankle in the last 12 months
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 |
|---|---|---|
| AgilusAlso: Hyaluronic AcidHyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks. | Device | Active |
| Normal salineNormal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks. | Device | Control |
Primary outcome
The Comparison Between the Agilus Injection and the Saline Control Injection Groups in the Proportion of Subjects Experiencing a Reduction in the Assessment of Pain Determined by the AOS Subscale for Pain.
Time frame: At 4, 12 and 26 weeks post 3rd injection
1 secondary outcome
Secondary Effectiveness Parameters That Will be Evaluated Include the Following That Evaluate Pain, Function, Subject's Global Assessment, Quality of Life and an Individual Subject Responder Analysis.
Time frame: At 4, 12 and 26 weeks post 3rd injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Judith Baumhauer, MD principal investigator
University of Rochester
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Agilus and Normal saline in people with OSTEOARTHRITIS, run by Cartiva, Inc. at 19 sites 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 4 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 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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 17 Aug 2017). 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?
The Comparison Between the Agilus Injection and the Saline Control Injection Groups in the Proportion of Subjects Experiencing a Reduction in the Assessment of Pain Determined by the AOS Subscale for Pain. (time frame: At 4, 12 and 26 weeks post 3rd injection). 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 17 Aug 2017.