NCT00503438

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2007

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

October 31, 2007

Completed
15.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2023

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

15.5 years

First QC Date

July 17, 2007

Last Update Submit

January 23, 2024

Conditions

OsteoarthritisRheumatoid ArthritisPost-Traumatic ArthritisSeptic ArthritisPrior Ankle Fusion

Keywords

ArthritisOsteoarthritisArthroplasty

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 years

Secondary Outcomes (1)

  • The American Orthopaedic Foot and Ankle Society (AOFAS) Score

    Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years

Other Outcomes (2)

  • The Foot Function Index (FFI)

    Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years

  • The Foot and Ankle Ability Measure (FAAM)

    Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years

Study Arms (1)

Salto Talaris Ankle

This is an Implant Registry of the approved Salto Talaris Ankle replacement device

Device: Salto Talaris Ankle

Interventions

Salto Talaris AnkleDEVICE

Salto Talaris Anatomic Ankle total joint prosthesis

Also known as: Salto Talaris
Salto Talaris Ankle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Foot and Ankle Center of South Texas

San Antonio, Texas, 78205, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

  • 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.

    PMID: 15241138BACKGROUND

  • Pyevich 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.

    PMID: 9801209BACKGROUND

  • Wood 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.

    PMID: 12729104BACKGROUND

MeSH Terms

Conditions

OsteoarthritisArthritis, RheumatoidArthritis, InfectiousArthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesInfections

Study Officials

  • Richard Marks

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2007

First Posted

July 18, 2007

Study Start

October 31, 2007

Primary Completion

April 21, 2023

Study Completion

April 21, 2023

Last Updated

January 24, 2024

Record last verified: 2024-01

Locations

US(2)