Ankle Joint Replacement Outcomes Study

NCT ID: NCT00503438

Last Updated: 2024-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2023-04-21

Brief Summary

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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

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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

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Osteoarthritis Rheumatoid Arthritis Post-Traumatic Arthritis Septic Arthritis Prior Ankle Fusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Salto Talaris Ankle

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

Salto Talaris Ankle

Intervention Type DEVICE

Salto Talaris Anatomic Ankle total joint prosthesis

Interventions

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Salto Talaris Ankle

Salto Talaris Anatomic Ankle total joint prosthesis

Intervention Type DEVICE

Other Intervention Names

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Salto Talaris

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Smith & Nephew, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Marks

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

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Foot and Ankle Center of South Texas

San Antonio, Texas, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15241138 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9801209 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12729104 (View on PubMed)

Other Identifiers

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T-STAS-001

Identifier Type: -

Identifier Source: org_study_id

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