ArthrodesisNCT01366989
INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation
An observational study of Arthrodesis and Degenerative Arthritis, run by Stryker Trauma and Extremities at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the radiographic outcomes of Total Ankle Arthroplasty in patients having a calcaneal stem. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthrodesis, Degenerative Arthritis, Rheumatoid Arthritis
- What is being tested?
- Radiographic evaluation of previously implanted patients
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to 4 Jun 2013
- 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: Patients who will be recruited for participation in this study received the TAA with calcaneal stem between December 6, 2005 and November 13, 2007 at approximately 28 sites.
Who may be able to join
- Patients who will be recruited for participation in this study received the TAA with calcaneal stem between December 6, 2005 and November 13, 2007 at approximately 28 sites.
Who cannot join
- Patients who will be recruited for participation in this study received the TAA with calcaneal stem between December 6, 2005 and November 13, 2007 at approximately 28 sites.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to evaluate the radiographic outcomes of Total Ankle Arthroplasty in patients having a calcaneal stem.
Read the detailed description
The primary objective of this study is to determine the radiographic outcomes of patients who have received TAA with the calcaneal stem. Due to the fixation of the stem in the calcaneus, talar component position, osteolysis and bone quality are of interest to the FDA. Specifically, subsidence and/or migration of the talar component, osteolysis as a measure of wear, and bone quality of the talus, cuboid and navicular are to be evaluated in this study. Therefore, the radiographic outcomes of this study aim to assess these parameters
- Conditions
- Arthrodesis, Degenerative Arthritis, Rheumatoid Arthritis, Complications; Arthroplasty, Mechanical
- Being tested
- Radiographic evaluation of previously implanted patients
- Keywords
- Total Ankle Arthroplasty
- Medical subject headings
- Ankylosis, Osteoarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiographic evaluation of previously implanted patientsDevice
Also called Radiographs of previously implanted patients
Radiographs of the ankle
| Study group | Role | What they receive |
|---|---|---|
| Total Ankle Arthroplasty with calcaneal stem | Patients received the TAA with calcaneal stem between 12/6/05 \& 11/13/07 at approximately 28 sites. Receives: Device: Radiographic evaluation of previously implanted patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Evaluation
Bone quality of the talus, navicular, and cuboid will be assessed on both the lateral and mortise views of the latest follow-up radiographs
Measured: Post operarative 1.2 -3.1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startOct 2010
- Primary completion4 Jun 2013
- Study completion4 Jun 2013
Why it stopped: The retrospective data review did not provide adequate information to continue the investigation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthrodesisStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Michael Bolognesi, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366989
- Sponsor's protocol ID
- 08-SJA-001
- Status last verified
- Feb 2017
- First submitted
- 2 Jun 2011
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation
- ClinicalTrials.gov ID
- NCT01366989
- Acronym / sponsor ID
- 08-SJA-001
- Conditions
- Arthrodesis, Degenerative Arthritis, Rheumatoid Arthritis, Complications; Arthroplasty, Mechanical
- Keywords
- Total Ankle Arthroplasty
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The retrospective data review did not provide adequate information to continue the investigation.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Collaborators
- Duke University
- Study start
- Oct 2010 (actual)
- Primary completion
- 4 Jun 2013 (actual)
- Study completion
- 4 Jun 2013 (actual)
- First posted
- 6 Jun 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 primary objective of this study is to evaluate the radiographic outcomes of Total Ankle Arthroplasty in patients having a calcaneal stem.
Detailed description
The primary objective of this study is to determine the radiographic outcomes of patients who have received TAA with the calcaneal stem. Due to the fixation of the stem in the calcaneus, talar component position, osteolysis and bone quality are of interest to the FDA. Specifically, subsidence and/or migration of the talar component, osteolysis as a measure of wear, and bone quality of the talus, cuboid and navicular are to be evaluated in this study. Therefore, the radiographic outcomes of this study aim to assess these parameters
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Ankle Arthroplasty with calcaneal stem | – | Device: Radiographic evaluation of previously implanted patientsPatients received the TAA with calcaneal stem between 12/6/05 \& 11/13/07 at approximately 28 sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will be recruited for participation in this study received the TAA with calcaneal stem between December 6, 2005 and November 13, 2007 at approximately 28 sites.
Key inclusion criteria (1 listed)
- Patients who will be recruited for participation in this study received the TAA with calcaneal stem between December 6, 2005 and November 13, 2007 at approximately 28 sites.
Key exclusion criteria (1 listed)
- Patients who will be recruited for participation in this study received the TAA with calcaneal stem between December 6, 2005 and November 13, 2007 at approximately 28 sites.
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 |
|---|---|---|
| Radiographic evaluation of previously implanted patientsAlso: Radiographs of previously implanted patientsRadiographs of the ankle | Device | Total Ankle Arthroplasty with calcaneal stem |
Primary outcome
Radiographic Evaluation
Time frame: Post operarative 1.2 -3.1 years
Bone quality of the talus, navicular, and cuboid will be assessed on both the lateral and mortise views of the latest follow-up radiographs
Results and safety
The study was stopped early (reason given: The retrospective data review did not provide adequate information to continue the investigation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 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.
Michael Bolognesi, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthrodesis and Degenerative Arthritis, run by Stryker Trauma and Extremities 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 1 inclusion and 1 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 Feb 2017. 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. 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 was stopped early (reason given: The retrospective data review did not provide adequate information to continue the investigation.). Results are not available in the source record.
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?
Radiographic Evaluation (time frame: Post operarative 1.2 -3.1 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 17 Feb 2017.