OsteoarthritisPhase 3NCT00586781
Study of the Scandinavian Total Ankle Replacement (STAR) for the Treatment of Bilateral Degenerative Ankle Disease
A Phase 3 study testing Scandinavian Total Ankle Replacement (STAR) in people with Osteoarthritis and Post-Traumatic Arthritis, run by Link America, Inc. at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety of the S.T.A.R. device for patients with bilateral disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Post-Traumatic Arthritis, Rheumatoid Arthritis
- What is being tested?
- Scandinavian Total Ankle Replacement (STAR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2001to Dec 2006
- Phase
- Phase 3
- 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
- Moderate or severe pain, loss of mobility and function of the ankle
- Primary arthrosis, post traumatic arthrosis or rheumatoid arthrosis
- At least six months of conservative treatment for severe ankle conditions
- Bilateral ankle disease that have not been enrolled in the pivotal study or single ankle disease and enrolled in the pivotal study but have subsequently developed ankle disease in the contralateral ankle and require surgical intervention
- Willing and able to give informed consent
Who cannot join
- Patients who have not reached skeletal maturity
- Active or prior deep infection in the ankle joint or adjacent bones
- Prior arthrodesis at the involved site
- History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol
- Obesity (weight greater than 250 lbs)
- History of current or prior drug abuse or alcoholism
Show all 10Show fewer
- Any physical condition precluding major surgery
- Prior surgery and/or injury that has adversely affected the ankle bone stock
- Severe osteoporotic or osteopenic condition or other conditions that may lead to inadequate implant fixation in the bone
- Insufficient ligament support
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Orthopedic Associates of Dallas
Dallas, Texas, 75246
Duke University Medical Center
Durham, North Carolina, 27710
University of Iowa
Iowa City, Iowa, 52242
Mayo Clinic
Jacksonville, Florida, 32224
Kansas University Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Investigational Device Exemption for the Scandinavian Total Ankle Replacement (STAR) - Bilateral Arm
The purpose of this study is to evaluate the safety of the S.T.A.R. device for patients with bilateral disease.
Read the detailed description
The specific objectives are to show that the safety data of the S.T.A.R. ankle arthroplasty is similar for treatment of single ankle disease (as defined in the pivotal study) and bilateral ankle disease. The bilateral disease may be identified at the time of enrollment or may have progressed after enrollment and treatment of the first ankle in the pivotal study.
- Being tested
- Scandinavian Total Ankle Replacement (STAR)
- Keywords
- ankle replacement, end-stage arthritis of the ankle, degenerative ankle disease
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scandinavian Total Ankle Replacement (STAR)Device
The device has three parts: two metal bearing surfaces (cobalt-chromium alloy) plates with bars that fit into the bone and one plastic (polyethylene) spacer that moves between the metal plates like a ball bearing. The materials in the S.T.A.R. device are the same materials used in total hip and knee implants.
| Study group | Role | What they receive |
|---|---|---|
| 3 | Experimental | The S.T.A.R. ankle system is the study device. The device has three parts: two metal bearing surfaces (cobalt-chromium alloy) plates with bars that fit into the bone and one plastic (polyethylene) spacer that moves between the metal plates like a ball bearing. The materials in the S.T.A.R. device are the same materials used in total hip and knee implants. Both ankles of every subject will be treated with the STAR ankle. Receives: Device: Scandinavian Total Ankle Replacement (STAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoints to be measured are: • Device failure or device removal/revision • Radiographically confirmed loosening and migration • Complications
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startSep 2001
- Primary completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Link America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Roger A Mann, MD, Principal investigator, Roger A Mann, IncMichael J Coughlin, MD, Principal investigator, Foot and Ankle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586781
- Sponsor's protocol ID
- Link-3
- Status last verified
- Dec 2007
- First submitted
- 21 Dec 2007
- Last updated
- 4 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigational Device Exemption for the Scandinavian Total Ankle Replacement (STAR) - Bilateral Arm
- ClinicalTrials.gov ID
- NCT00586781
- Acronym / sponsor ID
- Link-3
- Keywords
- ankle replacement, end-stage arthritis of the ankle, degenerative ankle disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Link America, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2001
- Primary completion
- Dec 2006 (actual)
- First posted
- 4 Jan 2008 (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.
The purpose of this study is to evaluate the safety of the S.T.A.R. device for patients with bilateral disease.
Detailed description
The specific objectives are to show that the safety data of the S.T.A.R. ankle arthroplasty is similar for treatment of single ankle disease (as defined in the pivotal study) and bilateral ankle disease. The bilateral disease may be identified at the time of enrollment or may have progressed after enrollment and treatment of the first ankle in the pivotal study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3 | Experimental | Device: Scandinavian Total Ankle Replacement (STAR)The S.T.A.R. ankle system is the study device. The device has three parts: two metal bearing surfaces (cobalt-chromium alloy) plates with bars that fit into the bone and one plastic (polyethylene) spacer that moves between the metal plates like a ball bearing. The materials in the S.T.A.R. device are the same materials used in total hip and knee implants. Both ankles of every subject will be treated with the STAR ankle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Moderate or severe pain, loss of mobility and function of the ankle
- Primary arthrosis, post traumatic arthrosis or rheumatoid arthrosis
- At least six months of conservative treatment for severe ankle conditions
- Bilateral ankle disease that have not been enrolled in the pivotal study or single ankle disease and enrolled in the pivotal study but have subsequently developed ankle disease in the contralateral ankle and require surgical intervention
- Willing and able to give informed consent
Key exclusion criteria (10 listed)
- Patients who have not reached skeletal maturity
- Active or prior deep infection in the ankle joint or adjacent bones
- Prior arthrodesis at the involved site
- History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol
- Obesity (weight greater than 250 lbs)
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 |
|---|---|---|
| Scandinavian Total Ankle Replacement (STAR)The device has three parts: two metal bearing surfaces (cobalt-chromium alloy) plates with bars that fit into the bone and one plastic (polyethylene) spacer that moves between the metal plates like a ball bearing. The materials in the S.T.A.R. device are the same materials used in total hip and knee implants. | Device | 3 |
Primary outcome
Safety endpoints to be measured are: • Device failure or device removal/revision • Radiographically confirmed loosening and migration • Complications
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2008.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
Roger A Mann, MD principal investigator
Roger A Mann, Inc
Michael J Coughlin, MD principal investigator
Foot and Ankle
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Scandinavian Total Ankle Replacement (STAR) in people with Osteoarthritis and Post-Traumatic Arthritis, run by Link America, Inc. at 5 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 4 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety endpoints to be measured are: • Device failure or device removal/revision • Radiographically confirmed loosening and migration • Complications (time frame: 12 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 4 Jan 2008.