Clinical trial NCT00503438: Ankle Joint Replacement Outcomes Study
Official title: Salto Talaris Anatomic Ankle Arthroplasty Outcomes Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Rheumatoid Arthritis
Post-Traumatic Arthritis
Septic Arthritis
Prior Ankle Fusion
Keywords: Arthritis
Osteoarthritis
Arthroplasty
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2007-07-18
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Survivorship of Salto Talaris Ankle Implant
timeFrame: 10 years
Secondary outcomes:
measure: The American Orthopaedic Foot and Ankle Society (AOFAS) Score
timeFrame: Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
Other outcomes:
measure: The Foot Function Index (FFI)
timeFrame: Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
measure: The Foot and Ankle Ability Measure (FAAM)
timeFrame: Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years
Locations:
city: San Antonio
country: United States
facility: Foot and Ankle Center of South Texas
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Richard Marks
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.