Rheumatoid Arthritis of AnkleNCT01366872
Agility LP Ankle Arthroplasty Outcomes
An observational study of Rheumatoid Arthritis of Ankle and Osteoarthritis of Ankle, run by Orthopaedic Associates of Michigan, PC at 1 site in United States.
Trial summary
This is a research study which is being done to determine the outcomes following Agility LP ankle replacement. This implant was approved by the FDA in 2007 and has been used since then with good early results. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis of Ankle, Osteoarthritis of Ankle, Traumatic Arthritis of Ankle
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Sep 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female and male subjects over the age of 18 at the time of procedure who have undergone ankle joint replacement using the DePuy Agility LP Device.
Who may be able to join
- Over 18 years old
- Can comprehend and sign the informed consent
- Patient must have undergone Agility LP ankle replacement between January 2006 to June 2008
Who cannot join
- Patient has had following procedures on the study limb within two years of TAA
- Revision of TAA
- Ankle arthrodesis
- Amputation
- Agility LP arthroplasty was done as a revision procedure for a failed TAA or as a takedown of ankle fusion.
- Any condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthopaedic Associates of Michigan, PC
Grand Rapids, Michigan, 49525
About this study
Official title: Agility LP Ankle Arthroplasty: Clinical and Radiographic Outcomes
This is a research study which is being done to determine the outcomes following Agility LP ankle replacement. This implant was approved by the FDA in 2007 and has been used since then with good early results. You are being asked to volunteer for this study because you have undergone Total Ankle Arthroplasty with Agility LP prosthesis. The purpose of the study is to compare the range of motion, level of pain and function during daily living prior to and after your ankle surgery.
- Keywords
- ankle, arthritis, total ankle arthroplasty, Agility LP,
- Medical subject headings
- Arthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Functional Outcomes Following Agility LP Ankle Replacement
Range of Motion - Combined total of dorsiflexion and plantarflexion. Full range of motion is described as 30 degrees or more. Partial limitation is described as 29 to 15 degrees. Range of motion that is less than 15 degrees is described as severely limited.
Measured: A Minimum of 2 Years Post Index Procedure
Secondary outcomes (2)
Evaluation of Complication and Reoperation Rates
Number of reported complications/reoperations following the index procedure.
Measured: A Minimum of 2 Years Post Index Procedure
Radiographic Predictors of Implant Failures and Poor Outcomes
Post-Operative radiographic disposition. Subsidence is described as the component sinking into the bone. Ingrowth is described as the implant components to conform into the tibia and talus.
Measured: A Minimum of 2 Years Post Index Procedure
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 startDec 2010
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid Arthritis of AnkleStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopaedic Associates of Michigan, PC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John G. Anderson, MD, Orthopaedic Associates of Michigan, PC
- Investigators
- John G Anderson, MD, Principal investigator, Orthopaedic Associates of Michigan, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366872
- Sponsor's protocol ID
- OAM-LP-2010
- Status last verified
- Nov 2012
- First submitted
- 2 Jun 2011
- Last updated
- 20 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agility LP Ankle Arthroplasty: Clinical and Radiographic Outcomes
- ClinicalTrials.gov ID
- NCT01366872
- Acronym / sponsor ID
- OAM-LP-2010
- Keywords
- ankle, arthritis, total ankle arthroplasty, Agility LP,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Orthopaedic Associates of Michigan, PCUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 6 Jun 2011 (estimated)
- Results
- Posted 20 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study which is being done to determine the outcomes following Agility LP ankle replacement. This implant was approved by the FDA in 2007 and has been used since then with good early results. You are being asked to volunteer for this study because you have undergone Total Ankle Arthroplasty with Agility LP prosthesis. The purpose of the study is to compare the range of motion, level of pain and function during daily living prior to and after your ankle surgery.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female and male subjects over the age of 18 at the time of procedure who have undergone ankle joint replacement using the DePuy Agility LP Device.
Key inclusion criteria (3 listed)
- Over 18 years old
- Can comprehend and sign the informed consent
- Patient must have undergone Agility LP ankle replacement between January 2006 to June 2008
Key exclusion criteria (6 listed)
- Patient has had following procedures on the study limb within two years of TAA
- Revision of TAA
- Ankle arthrodesis
- Amputation
- Agility LP arthroplasty was done as a revision procedure for a failed TAA or as a takedown of ankle fusion.
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
Assessment of Functional Outcomes Following Agility LP Ankle Replacement
Time frame: A Minimum of 2 Years Post Index Procedure
Range of Motion - Combined total of dorsiflexion and plantarflexion. Full range of motion is described as 30 degrees or more. Partial limitation is described as 29 to 15 degrees. Range of motion that is less than 15 degrees is described as severely limited.
2 secondary outcomes
Evaluation of Complication and Reoperation Rates
Time frame: A Minimum of 2 Years Post Index Procedure
Radiographic Predictors of Implant Failures and Poor Outcomes
Time frame: A Minimum of 2 Years Post Index Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John G Anderson, MD principal investigator
Orthopaedic Associates of Michigan, PC
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 Rheumatoid Arthritis of Ankle and Osteoarthritis of Ankle, run by Orthopaedic Associates of Michigan, PC 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 6 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 20 Dec 2012. 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?
Yes. Results are posted in the registry (first posted 20 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Assessment of Functional Outcomes Following Agility LP Ankle Replacement (time frame: A Minimum of 2 Years Post Index Procedure). 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 20 Dec 2012.