Ankle OsteoarthritisTAR1600NCT01986244
Total Ankle Replacement for Ankle Arthritis
An observational study of Ankle Osteoarthritis, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to prospectively evaluate the functional outcome and patient satisfaction of total ankle replacement for tibio-talar osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Osteoarthritis
- How many people
- 1,043 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2007to 5 Nov 2019
- 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: Adult patients who will benefit from a total ankle replacement.
Who may be able to join
- Adult patients (age > 18 years) who will benefit from a total ankle replacement, as determined by Drs. Nunley, DeOrio, Easley, or Adams, with the aid of the physical exam and routine radiography
- Treated at Duke University Medical Center
- Patients who have no medical conditions that would represent contraindications to surgery or anesthesia
Who cannot join
- Patients who do not meet the minimum age of 18 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Medical Plaza Page Road
Durham, North Carolina, 27703
About this study
The purpose of this study is to prospectively evaluate the functional outcome and patient satisfaction of total ankle replacement for tibio-talar osteoarthritis.
Read the detailed description
If a patient chooses to participate, they will be asked to sign the consent form and will be asked to complete the following patient outcome questionnaires: Visual Analog Pain Scale, Short-form 36, AOFAS hind foot score, and the Short Musculoskeletal Function Assessment questionnaire. The patient will then undergo surgery at a later date. Following surgery, the patient will present for routine follow-up appointments. At six month, one year, and yearly visits, the patients participating in the study will be asked to complete the previously mentioned outcome questionnaires. These are all normal follow-up visit time points; the patients will not be asked to return to clinic for any additional visits that would not be routine. At each visit, the patient will also receive plain x-rays. Plain x-rays are part of routine follow-up and not additional tests for this study. In addition, each patient will be tested pre-operatively as well as one year and two years post-operatively in order to gain a better understanding of the effect of total ankle replacements on lower extremity kinematics and kinetics. In order to understand the effect of the ankle replacement on lower extremity kinematics and kinetics, each subject will be asked to complete a series of functional tasks. First patients will be asked to complete a series of clinical tests to assess the patients ability to complete different balance tasks and walking trials. Patients will first be asked to stand with their legs approximately shoulder width apart on top of the one of the four force plates that are embedded in the ground in the lab. Patients will be asked to stand for at least 10 seconds. The time that they are able to remain balanced will be monitored as well as the movement of the center of pressure (COP) beneath the patient's feet. Each patient will then be asked to complete 3 other standing tasks on the force plate. These standing tasks will be a semi-tandem stance, tandem stance and single limb stance. The semi-tandem stance will require the patient to place one foot slightly in front of the other, but still side by side. The tandem stance will require the patients to place one foot in front of the other. Each of these tasks will be completed for 10 seconds or as long as possible while the COP is recorded. The second functional task to be completed is a four square step test. This test will consist of patients stepping forward, backward, and from side to side in order to assess their movement. This test will be timed from start to finish to see how long it takes for each patient to complete the task pre-operatively as well as post-operatively. Following the functional testing, each subject will have a series of reflective markers attached to different anatomical landmarks in order to monitor joint position and to be able to calculate joint moments during 3 different movement tasks. Once the markers have been placed patients will be asked to walk along a 10 meter walkway at a self selected speed which will be monitored using a timing system. In addition to a self-selected speed, each patient will be asked to walk at a standard speed of 1.3 m/s. Finally the patients will be asked to stand on both limbs and squat as far as possible as if sitting in a chair. Each of these tasks will be completed approximately seven times while lower extremity kinematics and kinetics will be recorded using an eight camera motion capture system and four force plates that are embedded within the 10 meter walkway. The only tests performed exclusively for research purposes will be the administered questionnaires and the gait analysis study. (The gait portion of this study is no longer being conducted.)
. The study will proceed until a minimum of 10-year follow-up is achieved for all patients. Questionnaires will be mailed out to the subjects at appropriate time points if they are unable to return to Duke.
- Conditions
- Ankle Osteoarthritis
- Keywords
- Osteoarthritis, Arthritis, Joint Diseases
- Medical subject headings
- Osteoarthritis, Arthritis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| STAR Total Ankle Replacement | Procedure: Total Ankle Replacement Surgery using the STAR | |
| Salto Talaris Total Ankle Replacement | Procedure: Total Ankle Replacement Surgery using the Salto Talaris | |
| In-Bone Total Ankle Replacement | Procedure: Total Ankle Replacement Surgery using the In-Bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Pain Scale (VAS)
To assess changes in pain across time following total ankle replacement across multiple time points. A visual analog scale of pain is an instrument used to measure the amount of pain a patient feels.
Measured: Preoperatively, 1yr, 2yr, 5yr, and 10yr
Change in Short Form Health Survey
To assess functional health and well being across time following total ankle replacement and to determine if there are significant differences.
Measured: Preoperatively, 1yr, 2yr, 5yr, and 10yr
Change in Short Musculoskeletal Function Assessment (SMFA)
SMFA is an outcome measure to provide a standardized measure of the actual physical limitations of the patient.
Measured: Preoperatively, 1yr, 2yr, 5yr, and 10yr
Change in AOFAS Hindfoot Scale questionnaire
The AOFAS combines subjective scores of pain and function provided by the patient with objective scores based on the surgeon's physical examination of the patient.
Measured: Preoperatively, 1yr, 2yr, 5yr, and 10yr
Change in Foot and Ankle Disability Index (FADI)
Patient reported function outcomes during activities of daily living.
Measured: Preoperatively, 1yr, 2yr, 5yr, and 10yr
Secondary outcomes (1)
Changes in Three dimensional kinematic and kinetic assessments during level walking
In order to understand the effect of the ankle replacement on lower extremity kinematics and kinetics, each subject will be asked to complete a series of functional tasks and level walking trials at each of the study timepoints
Measured: preoperatively, 1yr, 2yr, 5yr, and 10yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study start13 Jun 2007
- Primary completion5 Nov 2019
- Study completion5 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,043 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James A Nunley, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986244
- Sponsor's protocol ID
- Pro00001600
- Acronym
- TAR1600
- Status last verified
- May 2020
- First submitted
- 11 Nov 2013
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Ankle Replacement for Ankle Arthritis
- ClinicalTrials.gov ID
- NCT01986244
- Acronym / sponsor ID
- TAR1600 / Pro00001600
- Conditions
- Ankle Osteoarthritis
- Keywords
- Osteoarthritis, Arthritis, Joint Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,043 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 13 Jun 2007 (actual)
- Primary completion
- 5 Nov 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 18 Nov 2013 (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 prospectively evaluate the functional outcome and patient satisfaction of total ankle replacement for tibio-talar osteoarthritis.
Detailed description
If a patient chooses to participate, they will be asked to sign the consent form and will be asked to complete the following patient outcome questionnaires: Visual Analog Pain Scale, Short-form 36, AOFAS hind foot score, and the Short Musculoskeletal Function Assessment questionnaire. The patient will then undergo surgery at a later date. Following surgery, the patient will present for routine follow-up appointments. At six month, one year, and yearly visits, the patients participating in the study will be asked to complete the previously mentioned outcome questionnaires. These are all normal follow-up visit time points; the patients will not be asked to return to clinic for any additional visits that would not be routine. At each visit, the patient will also receive plain x-rays. Plain x-rays are part of routine follow-up and not additional tests for this study. In addition, each patient will be tested pre-operatively as well as one year and two years post-operatively in order to gain a better understanding of the effect of total ankle replacements on lower extremity kinematics and kinetics. In order to understand the effect of the ankle replacement on lower extremity kinematics and kinetics, each subject will be asked to complete a series of functional tasks. First patients will be asked to complete a series of clinical tests to assess the patients ability to complete different balance tasks and walking trials. Patients will first be asked to stand with their legs approximately shoulder width apart on top of the one of the four force plates that are embedded in the ground in the lab. Patients will be asked to stand for at least 10 seconds. The time that they are able to remain balanced will be monitored as well as the movement of the center of pressure (COP) beneath the patient's feet. Each patient will then be asked to complete 3 other standing tasks on the force plate. These standing tasks will be a semi-tandem stance, tandem stance and single limb stance. The semi-tandem stance will require the patient to place one foot slightly in front of the other, but still side by side. The tandem stance will require the patients to place one foot in front of the other. Each of these tasks will be completed for 10 seconds or as long as possible while the COP is recorded. The second functional task to be completed is a four square step test. This test will consist of patients stepping forward, backward, and from side to side in order to assess their movement. This test will be timed from start to finish to see how long it takes for each patient to complete the task pre-operatively as well as post-operatively. Following the functional testing, each subject will have a series of reflective markers attached to different anatomical landmarks in order to monitor joint position and to be able to calculate joint moments during 3 different movement tasks. Once the markers have been placed patients will be asked to walk along a 10 meter walkway at a self selected speed which will be monitored using a timing system. In addition to a self-selected speed, each patient will be asked to walk at a standard speed of 1.3 m/s. Finally the patients will be asked to stand on both limbs and squat as far as possible as if sitting in a chair. Each of these tasks will be completed approximately seven times while lower extremity kinematics and kinetics will be recorded using an eight camera motion capture system and four force plates that are embedded within the 10 meter walkway. The only tests performed exclusively for research purposes will be the administered questionnaires and the gait analysis study. (The gait portion of this study is no longer being conducted.)
. The study will proceed until a minimum of 10-year follow-up is achieved for all patients. Questionnaires will be mailed out to the subjects at appropriate time points if they are unable to return to Duke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STAR Total Ankle Replacement | – | –Procedure: Total Ankle Replacement Surgery using the STAR |
| Salto Talaris Total Ankle Replacement | – | –Procedure: Total Ankle Replacement Surgery using the Salto Talaris |
| In-Bone Total Ankle Replacement | – | –Procedure: Total Ankle Replacement Surgery using the In-Bone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who will benefit from a total ankle replacement.
Key inclusion criteria (3 listed)
- Adult patients (age > 18 years) who will benefit from a total ankle replacement, as determined by Drs. Nunley, DeOrio, Easley, or Adams, with the aid of the physical exam and routine radiography
- Treated at Duke University Medical Center
- Patients who have no medical conditions that would represent contraindications to surgery or anesthesia
Key exclusion criteria (1 listed)
- Patients who do not meet the minimum age of 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Visual Analog Pain Scale (VAS)
Time frame: Preoperatively, 1yr, 2yr, 5yr, and 10yr
To assess changes in pain across time following total ankle replacement across multiple time points. A visual analog scale of pain is an instrument used to measure the amount of pain a patient feels.
Change in Short Form Health Survey
Time frame: Preoperatively, 1yr, 2yr, 5yr, and 10yr
To assess functional health and well being across time following total ankle replacement and to determine if there are significant differences.
Change in Short Musculoskeletal Function Assessment (SMFA)
Time frame: Preoperatively, 1yr, 2yr, 5yr, and 10yr
SMFA is an outcome measure to provide a standardized measure of the actual physical limitations of the patient.
Change in AOFAS Hindfoot Scale questionnaire
Time frame: Preoperatively, 1yr, 2yr, 5yr, and 10yr
The AOFAS combines subjective scores of pain and function provided by the patient with objective scores based on the surgeon's physical examination of the patient.
Change in Foot and Ankle Disability Index (FADI)
Time frame: Preoperatively, 1yr, 2yr, 5yr, and 10yr
Patient reported function outcomes during activities of daily living.
1 secondary outcome
Changes in Three dimensional kinematic and kinetic assessments during level walking
Time frame: preoperatively, 1yr, 2yr, 5yr, and 10yr
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 6 May 2020.
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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.
James A Nunley, 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 Ankle Osteoarthritis, run by Duke University 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 3 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: finished, as of the sponsor's last update on 6 May 2020. 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 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?
Change in Visual Analog Pain Scale (VAS) (time frame: Preoperatively, 1yr, 2yr, 5yr, and 10yr). The study lists 5 primary outcomes in all. 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 6 May 2020.