Primary ArthrosisSTAR 2 PASNCT01284283
2-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System (STAR) Ankle Under Actual Conditions of Use
A study testing Scandinavian Total Ankle Replacement System (STAR Ankle) in people with Primary Arthrosis and Post Traumatic Arthritis, run by Encore Medical, L.P. at 9 sites in United States.
Trial summary
This post-approval study is being conducted to examine the performance of the STAR Ankle under actual conditions of use. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Arthrosis, Post Traumatic Arthritis, Rheumatoid Arthritis
- What is being tested?
- Scandinavian Total Ankle Replacement System (STAR Ankle)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 9 sitesUnited States
- Study dates
- Nov 2009to Mar 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Moderate or severe pain, loss of mobility and function of the ankle (Buechel-Pappas Scale)
- Primary arthrosis, post traumatic arthrosis or rheumatoid arthrosis
- At least six months of conservative treatment for severe ankle conditions, confirmed by the patient medical history, radiograph studies and medication record
- Willing and able to give informed consent
Who cannot join
- Patients who have not reached skeletal maturity
- Active or prior deep infection inthe 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 prior drug abuse or alcoholism
Show all 22Show fewer
- Any physical condition precluding major surgery
- Hindfoot malpositioned by more than 35 degrees or forefoot malalignment which would preclude a plantigrade foot
- Lower extremity vascular insufficiency demonstrated by Doppler arterial pressure
- Avascular necrosis of the talus
- Inadequate skin coverage above the ankle joint
- Patients under the age of 35 who are unwilling or unable to accept the physical limitations imposed by ankle arthroplasty, including limitations on certain vigorous physical activities (e.g. basketball, football) and on manual labor
- Juvenile onset Type I diabetes
- Adult onset Type II diabetes when accompanied by neuropathic changes or a history of foot infection in either foot
- Pregnancy
- Avascular necrosis of the tibia
- Significant bone tumor of the foot or ankle
- Severe deformity that would not normally be eligible for ankle 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
- Motor dysfunction due to neuromuscular impairment
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Center for Foot and Ankle Restoration
Dallas, Texas, 75231
Cedars Sinai Medical Center
Los Angeles, California, 90048
Kenneth Mroczek, MD-NYU
New York, New York, 10003
Palo Alto Medical Research Foundation (Sutter Health)
Palo Alto, California, 94301
University of Pennsylvania Health Systems-PA Foot and Ankle Surgeons
Philadelphia, Pennsylvania, 19106
The CORE Institute
Phoenix, Arizona, 85023
Reno Orthopaedic Center
Reno, Nevada, 89503
William Beaumont Hospital
Royal Oak, Michigan, 48085
Kaiser Permanente
San Francisco, California, 94118
About this study
Official title: 2-Year Post-Approval Study to Investigate the STAR Ankle Under Actual Conditions of Use
This post-approval study is being conducted to examine the performance of the STAR Ankle under actual conditions of use.
Read the detailed description
This investigation is a prospective, multi-center, single-arm study. 98 subjects are to be enrolled in this clinical investigation. Enrolled subjects will be assessed at Pre-Operative, Operative/Discharge, and at 6 Weeks, 6, 12, and 24 Months after the index procedure. Safety, efficacy, and effectiveness analyses will be performed for all follow-up points during the study.
- Being tested
- Scandinavian Total Ankle Replacement System (STAR Ankle)
- Keywords
- Arthrosis, Rheumatoid Arthrosis, Arthritic Joint, Rheumatoid Arthritis, Osteoarthritis, Total Ankle Replacement
- 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
For total ankle replacement
| Study group | Role | What they receive |
|---|---|---|
| Single | Other | 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.
Primary Endpoint
The primary objective of this study is to examine the performance of the STAR™ Ankle under actual conditions of use, employing the approved instructions for use, labeling, and instrumentation. The principal endpoint consists of evaluating the safety and effectiveness of the STAR™ Ankle. Overall patient success is defined as:
- ≥ 40 point improvement in total Buechel-Pappas Scale score
- No device failures
- Radiographic success (no clinically significant radiographic evidence of loosening, tilting or migration > 4mm)
- No major complications
Measured: 2 years
Secondary outcomes (1)
Secondary Endpoints
In addition to the principal endpoint, information on the following efficacy outcomes will be assessed:
- Total Buechel-Pappas Scale score
- Pain Visual Analog Scale
- Quality of Life
- American Orthopaedic Foot \& Ankle Society (AOFAS) Ankle Hindfoot Scale
The following radiographic endpoints will be assessed by anterior/posterior and lateral radiographs by the treating surgeon and an independent radiographic reviewer:
- Radiolucency
- Migration
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startNov 2009
- Primary completionMar 2021
- Study completionMar 2021
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Encore Medical, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Maartense, MD, Study director, Stryker Nordic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284283
- Sponsor's protocol ID
- STAR 2 Year
- Acronym
- STAR 2 PAS
- Status last verified
- Jul 2022
- First submitted
- 2 Nov 2010
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2-Year Post-Approval Study to Investigate the STAR Ankle Under Actual Conditions of Use
- ClinicalTrials.gov ID
- NCT01284283
- Acronym / sponsor ID
- STAR 2 PAS / STAR 2 Year
- Keywords
- Arthrosis, Rheumatoid Arthrosis, Arthritic Joint, Rheumatoid Arthritis, Osteoarthritis, Total Ankle Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Encore Medical, L.P.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Mar 2021 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 26 Jan 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.
This post-approval study is being conducted to examine the performance of the STAR Ankle under actual conditions of use.
Detailed description
This investigation is a prospective, multi-center, single-arm study. 98 subjects are to be enrolled in this clinical investigation. Enrolled subjects will be assessed at Pre-Operative, Operative/Discharge, and at 6 Weeks, 6, 12, and 24 Months after the index procedure. Safety, efficacy, and effectiveness analyses will be performed for all follow-up points during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Other | Device: Scandinavian Total Ankle Replacement System (STAR Ankle)Device: Scandinavian Total Ankle Replacement System (STAR Ankle) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Moderate or severe pain, loss of mobility and function of the ankle (Buechel-Pappas Scale)
- Primary arthrosis, post traumatic arthrosis or rheumatoid arthrosis
- At least six months of conservative treatment for severe ankle conditions, confirmed by the patient medical history, radiograph studies and medication record
- Willing and able to give informed consent
Key exclusion criteria (22 listed)
- Patients who have not reached skeletal maturity
- Active or prior deep infection inthe 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 System (STAR Ankle)Also: STARFor total ankle replacement | Device | Single |
Primary outcome
Primary Endpoint
Time frame: 2 years
The primary objective of this study is to examine the performance of the STAR™ Ankle under actual conditions of use, employing the approved instructions for use, labeling, and instrumentation. The principal endpoint consists of evaluating the safety and effectiveness of the STAR™ Ankle. Overall patient success is defined as: 1. ≥ 40 point improvement in total Buechel-Pappas Scale score 2. No device failures 3. Radiographic success (no clinically significant radiographic evidence of loosening, tilting or migration > 4mm) 4. No major complications
1 secondary outcome
Secondary Endpoints
Time frame: 2 years
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 29 Jul 2022.
- 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.
Stefan Maartense, MD study director
Stryker Nordic
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scandinavian Total Ankle Replacement System (STAR Ankle) in people with Primary Arthrosis and Post Traumatic Arthritis, run by Encore Medical, L.P. at 9 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 22 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 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Primary Endpoint (time frame: 2 years). 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 29 Jul 2022.