Primary ArthrosisSTAR 8NCT01288586
Post-Approval Study to Investigate the Long Term (8 Year) Survivorship of STAR Ankle Among Continued Access Study Patients
An observational study of Primary Arthrosis, run by Stryker Trauma and Extremities at 5 sites in United States.
Trial summary
The purpose of this study is to examine the long term survivorship of the Scandinavian Total Ankle Replacement (STAR). Specifically, this study focuses on the revision and/or removal rate of any component of the STAR ankle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Arthrosis
- What is being tested?
- Scandinavian Total Ankle Replacement System (STAR Ankle)
- Type of treatment
- Medical device
- How many people
- 87 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 Oct 2009to 14 Nov 2016
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of all living subjects who participated in the continued access study.
Who may be able to join
- Only patients that participated in the continued access study make up the patient cohort for this long-term follow-up study.
- Willing and able to give informed consent.
Who cannot join
- Subjects who were withdrawn or withdrew consent to participate in the investigation
- Subjects who do not consent to participate in long-term or provide personal contact information to the sponsor(solely for the purposes of tracking subjects to help ensure follow-up compliance)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
St. Alphonsus Medical Group, Coughlin Foot & Ankle Clinic
Boise, Idaho, 83706
Duke University
Durham, North Carolina, 27703
Kansas University Medical Center
Kansas City, Kansas, 66160
Oakland Bone & Joint Specialists
Oakland, California, 94612
Foundations of Orthopedic Research and Education
Temple Terrace, Florida, 33637
About this study
Official title: Post-Approval Study to Investigate the Long Term (8 Year) Survivorship of Scandinavian Total Ankle Replacement (STAR) Ankle Among Continued Access Study Patients
The purpose of this study is to examine the long term survivorship of the Scandinavian Total Ankle Replacement (STAR). Specifically, this study focuses on the revision and/or removal rate of any component of the STAR ankle.
- Conditions
- Primary Arthrosis
- Being tested
- Scandinavian Total Ankle Replacement System (STAR Ankle)
- Keywords
- Post Traumatic Arthritis, Rheumatoid Arthritis, Osteoarthritis
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scandinavian Total Ankle Replacement System (STAR Ankle)Device
Also called STAR
Total Ankle Replacement
| Study group | Role | What they receive |
|---|---|---|
| Device | Scandinavian Total Ankle Replacement System (STAR Ankle) Receives: Device: Scandinavian Total Ankle Replacement System (STAR Ankle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective for this study is to examine the long-term survivorship of the STAR Ankle
Obtain information on the revision and removal rate for the STAR Ankle over time.
Measured: 8 year
Secondary outcomes (1)
American Orthopaedic Foot and Ankle Society questionnaire will be used to evaluate and monitor the progress of patients following foot and ankle surgery.
Measured: 8 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study start5 Oct 2009
- Primary completion14 Nov 2016
- Study completion14 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary ArthrosisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Jay, DPM, Study director, Stryker Nordic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288586
- Sponsor's protocol ID
- STAR 8 Year
- Acronym
- STAR 8
- Status last verified
- Mar 2017
- First submitted
- 4 Nov 2010
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Approval Study to Investigate the Long Term (8 Year) Survivorship of Scandinavian Total Ankle Replacement (STAR) Ankle Among Continued Access Study Patients
- ClinicalTrials.gov ID
- NCT01288586
- Acronym / sponsor ID
- STAR 8 / STAR 8 Year
- Conditions
- Primary Arthrosis
- Keywords
- Post Traumatic Arthritis, Rheumatoid Arthritis, Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2009 (actual)
- Primary completion
- 14 Nov 2016 (actual)
- Study completion
- 14 Nov 2016 (actual)
- First posted
- 2 Feb 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.
The purpose of this study is to examine the long term survivorship of the Scandinavian Total Ankle Replacement (STAR). Specifically, this study focuses on the revision and/or removal rate of any component of the STAR ankle.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device | – | Device: Scandinavian Total Ankle Replacement System (STAR Ankle)Scandinavian Total Ankle Replacement System (STAR Ankle) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of all living subjects who participated in the continued access study.
Key inclusion criteria (2 listed)
- Only patients that participated in the continued access study make up the patient cohort for this long-term follow-up study.
- Willing and able to give informed consent.
Key exclusion criteria (2 listed)
- Subjects who were withdrawn or withdrew consent to participate in the investigation
- Subjects who do not consent to participate in long-term or provide personal contact information to the sponsor(solely for the purposes of tracking subjects to help ensure follow-up compliance)
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 System (STAR Ankle)Also: STARTotal Ankle Replacement | Device | Device |
Primary outcome
The primary objective for this study is to examine the long-term survivorship of the STAR Ankle
Time frame: 8 year
Obtain information on the revision and removal rate for the STAR Ankle over time.
1 secondary outcome
American Orthopaedic Foot and Ankle Society questionnaire will be used to evaluate and monitor the progress of patients following foot and ankle surgery.
Time frame: 8 year
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 27 Mar 2017.
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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.
Richard Jay, DPM study director
Stryker Nordic
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Arthrosis, run by Stryker Trauma and Extremities 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 2 inclusion and 2 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 27 Mar 2017. 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.
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?
The primary objective for this study is to examine the long-term survivorship of the STAR Ankle (time frame: 8 year). 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 27 Mar 2017.