OsteoarthritisNCT00503438
Ankle Joint Replacement Outcomes Study
An observational study of Osteoarthritis and Rheumatoid Arthritis, run by Smith & Nephew, Inc. at 2 sites in United States.
Trial summary
This post market outcome study will look at the therapeutic results of the Salto Talaris Anatomic ankle prosthesis. The study population will consist of patients who will undergo an ankle arthroplasty procedure with a Salto Talaris ankle implant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Post-Traumatic Arthritis
- What is being tested?
- Salto Talaris Ankle
- Type of treatment
- Medical device
- How many people
- 76 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Oct 2007to 21 Apr 2023
- 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: Candidates will be considered regardless of gender, race or ethnicity. The racial, gender and ethnic characteristics of the proposed patient population will reflect the demographics of the surrounding area.
Who may be able to join
- Subjects that need an ankle joint replacement due to arthritis or failed prior fusion.
- Subjects who have failed standard conservative management of their ankle condition
Who cannot join
- Class IV or higher anesthetic risk
- Subjects who are not able to comply with the study procedures
- Known contraindications to joint replacement such as active infection, complete talar necrosis, insufficient quality of bone stock, ligament laxity, severe osteopenia, Charcot's arthropathy
- Unwilling to be followed for 5 years
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Foot and Ankle Center of South Texas
San Antonio, Texas, 78205
About this study
Official title: Salto Talaris Anatomic Ankle Arthroplasty Outcomes Study
This post market outcome study will look at the therapeutic results of the Salto Talaris Anatomic ankle prosthesis. The study population will consist of patients who will undergo an ankle arthroplasty procedure with a Salto Talaris ankle implant. An analysis will be conducted of the results, complications and revisions of this prosthesis based on the etiology for which the ankle arthroplasty was performed.
Read the detailed description
This is a prospective, multi-center study that will capture the therapeutic results of the Salto Talaris Anatomic ankle prosthesis in the treatment of various ankle afflictions.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Post-Traumatic Arthritis, Septic Arthritis, Prior Ankle Fusion
- Being tested
- Salto Talaris Ankle
- Keywords
- Arthritis, Osteoarthritis, Arthroplasty
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Arthritis, Infectious, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salto Talaris AnkleDevice
Also called Salto Talaris
Salto Talaris Anatomic Ankle total joint prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Salto Talaris Ankle | This is an Implant Registry of the approved Salto Talaris Ankle replacement device Receives: Device: Salto Talaris Ankle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship of Salto Talaris Ankle Implant
Count of participants without a failed ankle arthroplasty. Ankle arthroplasty will be considered as failed if the implant is revised or removed and the ankle fused.
Measured: 10 years
Secondary outcomes (1)
The American Orthopaedic Foot and Ankle Society (AOFAS) Score
AOFAS ankle evaluation form is a commonly used standardized assessment of foot and ankle function divided into three anatomic regions. The scale used for this study will be the Ankle-Hindfoot Scale that ranges from 0 to 100. A score of 100 points is the maximum for a patient presenting in excellent condition. The score decreases as pain, limited range of motion, daily activities, joint instability, and alignment are assessed.
Measured: Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study start31 Oct 2007
- Primary completion21 Apr 2023
- Study completion21 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Marks, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503438
- Sponsor's protocol ID
- T-STAS-001
- Status last verified
- Jan 2024
- First submitted
- 17 Jul 2007
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Bonnin M, Judet T, Colombier JA, Buscayret F, Graveleau N, Piriou P. Midterm results of the Salto Total Ankle Prosthesis. Clin Orthop Relat Res. 2004 Jul;(424):6-18. doi: 10.1097/01.blo.0000132407.75881.a0.
PubMed 15241138Pyevich MT, Saltzman CL, Callaghan JJ, Alvine FG. Total ankle arthroplasty: a unique design. Two to twelve-year follow-up. J Bone Joint Surg Am. 1998 Oct;80(10):1410-20.
PubMed 9801209Wood PL, Deakin S. Total ankle replacement. The results in 200 ankles. J Bone Joint Surg Br. 2003 Apr;85(3):334-41. doi: 10.1302/0301-620x.85b3.13849.
PubMed 12729104
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salto Talaris Anatomic Ankle Arthroplasty Outcomes Study
- ClinicalTrials.gov ID
- NCT00503438
- Acronym / sponsor ID
- T-STAS-001
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Post-Traumatic Arthritis, Septic Arthritis, Prior Ankle Fusion
- Keywords
- Arthritis, Osteoarthritis, Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2007 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 18 Jul 2007 (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 market outcome study will look at the therapeutic results of the Salto Talaris Anatomic ankle prosthesis. The study population will consist of patients who will undergo an ankle arthroplasty procedure with a Salto Talaris ankle implant. An analysis will be conducted of the results, complications and revisions of this prosthesis based on the etiology for which the ankle arthroplasty was performed.
Detailed description
This is a prospective, multi-center study that will capture the therapeutic results of the Salto Talaris Anatomic ankle prosthesis in the treatment of various ankle afflictions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Salto Talaris Ankle | – | Device: Salto Talaris AnkleThis is an Implant Registry of the approved Salto Talaris Ankle replacement device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Candidates will be considered regardless of gender, race or ethnicity. The racial, gender and ethnic characteristics of the proposed patient population will reflect the demographics of the surrounding area.
Key inclusion criteria (2 listed)
- Subjects that need an ankle joint replacement due to arthritis or failed prior fusion.
- Subjects who have failed standard conservative management of their ankle condition
Key exclusion criteria (4 listed)
- Class IV or higher anesthetic risk
- Subjects who are not able to comply with the study procedures
- Known contraindications to joint replacement such as active infection, complete talar necrosis, insufficient quality of bone stock, ligament laxity, severe osteopenia, Charcot's arthropathy
- Unwilling to be followed for 5 years
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 |
|---|---|---|
| Salto Talaris AnkleAlso: Salto TalarisSalto Talaris Anatomic Ankle total joint prosthesis | Device | Salto Talaris Ankle |
Primary outcome
Survivorship of Salto Talaris Ankle Implant
Time frame: 10 years
Count of participants without a failed ankle arthroplasty. Ankle arthroplasty will be considered as failed if the implant is revised or removed and the ankle fused.
1 secondary outcome
The American Orthopaedic Foot and Ankle Society (AOFAS) Score
Time frame: Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 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 24 Jan 2024.
- Background: PubMed 15241138Bonnin M, Judet T, Colombier JA, Buscayret F, Graveleau N, Piriou P. Midterm results of the Salto Total Ankle Prosthesis. Clin Orthop Relat Res. 2004 Jul;(424):6-18. doi: 10.1097/01.blo.0000132407.75881.a0.
- Background: PubMed 9801209Pyevich MT, Saltzman CL, Callaghan JJ, Alvine FG. Total ankle arthroplasty: a unique design. Two to twelve-year follow-up. J Bone Joint Surg Am. 1998 Oct;80(10):1410-20.
- Background: PubMed 12729104Wood PL, Deakin S. Total ankle replacement. The results in 200 ankles. J Bone Joint Surg Br. 2003 Apr;85(3):334-41. doi: 10.1302/0301-620x.85b3.13849.
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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.
Richard Marks principal investigator
Medical College of Wisconsin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Rheumatoid Arthritis, run by Smith & Nephew, Inc. at 2 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 2 inclusion and 4 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 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Survivorship of Salto Talaris Ankle Implant (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00503438, which also lists 3 linked publications.
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 24 Jan 2024.