ArthritisNCT01641848
INBONE™ Total Ankle Prosthesis With Long Talar Stem
A study testing INBONE™ Total Ankle Prosthesis with Long Talar Stem in people with Arthritis and Infection of Total Ankle Joint Prosthesis, run by Stryker Trauma and Extremities at 1 site in United States.
Trial summary
The primary objective of this study is to collect preoperative, operative and postoperative clinical assessments of patients that qualify for surgical implantation of the INBONE™ Total Ankle Prosthesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Infection of Total Ankle Joint Prosthesis
- What is being tested?
- INBONE™ Total Ankle Prosthesis with Long Talar Stem
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Dec 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has sufficient soft tissue and muscle strength to support stable, anatomic positioning and motion of arthroplasty components as determined by the investigator
- Subject must have sufficient skin for wound coverage.
- Subject demonstrates subtalar joint insufficiency as defined by any of the following:
- (1)range of motion <50 percent of the contralateral, non-diseased side (2)pain during physical examination of the subtalar joint (3)fusion
- AND
- Subject demonstrates tibio-talar joint insufficiency as defined by any of the following:
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- end stage arthritis as determined by the investigator on plain radiographs
- pain during physical examination of the tibio-talar joint
- fusion
- non-union
- failed Total Ankle Replacement 4.Subject has Body Mass Index (BMI) < 40 5.Subject has sufficient calcaneal bone stock as determined by the investigator 6.Subject is able to or capable of providing consent to participate in the clinical investigation and has medical insurance to cover costs associated with their medical care or is willing to assume personal responsibility for costs 7.Subject agrees to comply with this protocol, including participating in required follow-up visits at the investigations site and completing study questionnaires
Who cannot join
- Subject is skeletally immature and under 21 years of age
- Subject has experienced local or systemic infection within the past twelve months
- Subject has symptomatic ankle disease or has been treated operatively on the contralateral side
- Subject has vascular and kidney insufficiencies
- Subject is suspected to have neuropathy of the foot or ankle
- Subject has impaired vascular circulation in the affected limb
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- Subject has skin condition that may impair wound healing
- Subject has known allergy to cobalt, chromium, molybdenum, titanium, aluminum, vanadium, or nickel
- Subjects on long term medications which may compromise bone stock (e.g. long term steroids, NSAIDS, etc., physicians discretion
- Subject is unwilling or unable to comply with a rehabilitation program
- Subject is known to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser
- Subject is currently participating in any investigational study not related to this study's preoperative and postoperative care.
- Subject has rheumatoid arthritis (RA)
- Subject has been diagnosed with osteoporosis as defined as a DXA t-score >-2.5.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthopaedic Foot and Ankle Center
Columbus, Ohio, 43082
About this study
Official title: Limited Enrollment of the INBONE™ Total Ankle Prosthesis With Long Talar Stem
The primary objective of this study is to collect preoperative, operative and postoperative clinical assessments of patients that qualify for surgical implantation of the INBONE™ Total Ankle Prosthesis.
Read the detailed description
The FDA approved the "limited enrollment" registry to provide us with additional clinical data from which to design a pivotal IDE study. FDA has stated that their decision for this was based upon "adequate safety information" which was submitted to them as part of the original IDE submission. Therefore, the purpose of this "limited enrollment" registry study is to gather initial data on the device's performance, when used with a Calcaneal Stem.
- Being tested
- INBONE™ Total Ankle Prosthesis with Long Talar Stem
- Keywords
- Total Ankle Arthroplasty
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INBONE™ Total Ankle Prosthesis with Long Talar StemDevice
INBONE™ Total Ankle Prosthesis with Long Talar Stem when used with a Calcaneal Stem
| Study group | Role | What they receive |
|---|---|---|
| Arthritic and injured ankles | Experimental | InBone TAA Receives: Device: INBONE™ Total Ankle Prosthesis with Long Talar Stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
to measure the subject's pain, disability and activity level restrictions within the last week.
The FFI, Foot Function Index is a validated self-administered scoring system designed to measure the subject's pain, disability and activity levels within the past week. Possible scores range from 0-100 with a lower score representing less pain, greater function and less restricted ambulation.
Measured: to measure change from pre-op (baseline) at specified intervals up to 24 months post-op
Secondary outcomes (1)
Radiographic Evaluation
Standard AP and lateral and oblique x-rays will be obtained at pre-operatively, and at 6 weeks, 3, 6, 12 and 24 months postoperatively. Any standard of care image can be performed 30 days prior to consenting.
Measured: to measure change from pre-op to post-op at intervals up to 24 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startDec 2010
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Lack of patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Orthopedic Foot and Ankle Center, Ohio
- Responsible party
- Sponsor
- Investigators
- Thomas Lee, M.D., Principal investigator, Orthopedic Foot and Ankle Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641848
- Sponsor's protocol ID
- 09-SJA-002
- Status last verified
- Aug 2013
- First submitted
- 3 Jun 2011
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Limited Enrollment of the INBONE™ Total Ankle Prosthesis With Long Talar Stem
- ClinicalTrials.gov ID
- NCT01641848
- Acronym / sponsor ID
- 09-SJA-002
- Keywords
- Total Ankle Arthroplasty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patient enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Collaborators
- Orthopedic Foot and Ankle Center, Ohio
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Jul 2012 (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 collect preoperative, operative and postoperative clinical assessments of patients that qualify for surgical implantation of the INBONE™ Total Ankle Prosthesis.
Detailed description
The FDA approved the "limited enrollment" registry to provide us with additional clinical data from which to design a pivotal IDE study. FDA has stated that their decision for this was based upon "adequate safety information" which was submitted to them as part of the original IDE submission. Therefore, the purpose of this "limited enrollment" registry study is to gather initial data on the device's performance, when used with a Calcaneal Stem.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthritic and injured ankles | Experimental | Device: INBONE™ Total Ankle Prosthesis with Long Talar StemInBone TAA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject has sufficient soft tissue and muscle strength to support stable, anatomic positioning and motion of arthroplasty components as determined by the investigator
- Subject must have sufficient skin for wound coverage.
- Subject demonstrates subtalar joint insufficiency as defined by any of the following:
- (1)range of motion <50 percent of the contralateral, non-diseased side (2)pain during physical examination of the subtalar joint (3)fusion
- AND
Key exclusion criteria (14 listed)
- Subject is skeletally immature and under 21 years of age
- Subject has experienced local or systemic infection within the past twelve months
- Subject has symptomatic ankle disease or has been treated operatively on the contralateral side
- Subject has vascular and kidney insufficiencies
- Subject is suspected to have neuropathy of the foot or ankle
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 |
|---|---|---|
| INBONE™ Total Ankle Prosthesis with Long Talar StemINBONE™ Total Ankle Prosthesis with Long Talar Stem when used with a Calcaneal Stem | Device | Arthritic and injured ankles |
Primary outcome
to measure the subject's pain, disability and activity level restrictions within the last week.
Time frame: to measure change from pre-op (baseline) at specified intervals up to 24 months post-op
The FFI, Foot Function Index is a validated self-administered scoring system designed to measure the subject's pain, disability and activity levels within the past week. Possible scores range from 0-100 with a lower score representing less pain, greater function and less restricted ambulation.
1 secondary outcome
Radiographic Evaluation
Time frame: to measure change from pre-op to post-op at intervals up to 24 months postoperatively.
Results and safety
The study was stopped early (reason given: Lack of patient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
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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.
Thomas Lee, M.D. principal investigator
Orthopedic Foot and Ankle Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INBONE™ Total Ankle Prosthesis with Long Talar Stem in people with Arthritis and Infection of Total Ankle Joint Prosthesis, 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 11 inclusion and 14 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 22 May 2014. 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: Lack of patient enrollment). 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?
to measure the subject's pain, disability and activity level restrictions within the last week. (time frame: to measure change from pre-op (baseline) at specified intervals up to 24 months post-op). 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 22 May 2014.