Clinical trial NCT01284283: 2-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System (STAR) Ankle Under Actual Conditions of Use
Official title: 2-Year Post-Approval Study to Investigate the STAR Ankle Under Actual Conditions of Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Arthrosis
Post Traumatic Arthritis
Rheumatoid Arthritis
Osteoarthritis
Keywords: Arthrosis
Rheumatoid Arthrosis
Arthritic Joint
Rheumatoid Arthritis
Osteoarthritis
Total Ankle Replacement
Lead sponsor: Encore Medical, L.P.
Sponsor class: INDUSTRY
First posted: 2011-01-26
Enrollment: 102
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This post-approval study is being conducted to examine the performance of the STAR Ankle under actual conditions of use.

Detailed description: This investigation is a prospective, multi-center, single-arm study. 98 subjects are to be enrolled in this clinical investigation. Enrolled subjects will be assessed at Pre-Operative, Operative/Discharge, and at 6 Weeks, 6, 12, and 24 Months after the index procedure. Safety, efficacy, and effectiveness analyses will be performed for all follow-up points during the study.

Eligibility criteria: Inclusion Criteria:

* Moderate or severe pain, loss of mobility and function of the ankle (Buechel-Pappas Scale)
* Primary arthrosis, post traumatic arthrosis or rheumatoid arthrosis
* At least six months of conservative treatment for severe ankle conditions, confirmed by the patient medical history, radiograph studies and medication record
* Willing and able to give informed consent

Exclusion Criteria:

* Patients who have not reached skeletal maturity
* Active or prior deep infection inthe ankle joint or adjacent bones
* Prior arthrodesis at the involved site
* History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol
* Obesity (weight greater than 250 lbs)
* History of current prior drug abuse or alcoholism
* Any physical condition precluding major surgery
* Hindfoot malpositioned by more than 35 degrees or forefoot malalignment which would preclude a plantigrade foot
* Lower extremity vascular insufficiency demonstrated by Doppler arterial pressure
* Avascular necrosis of the talus
* Inadequate skin coverage above the ankle joint
* Patients under the age of 35 who are unwilling or unable to accept the physical limitations imposed by ankle arthroplasty, including limitations on certain vigorous physical activities (e.g. basketball, football) and on manual labor
* Juvenile onset Type I diabetes
* Adult onset Type II diabetes when accompanied by neuropathic changes or a history of foot infection in either foot
* Pregnancy
* Avascular necrosis of the tibia
* Significant bone tumor of the foot or ankle
* Severe deformity that would not normally be eligible for ankle surgery
* Prior surgery and/or injury that has adversely affected the ankle bone stock
* Severe osteoporotic or osteopenic condition or other conditions that may lead to inadequate implant fixation in the bone
* Insufficient ligament support
* Motor dysfunction due to neuromuscular impairment

Primary outcomes:
measure: Primary Endpoint
timeFrame: 2 years
Secondary outcomes:
measure: Secondary Endpoints
timeFrame: 2 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: The CORE Institute
state: Arizona
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Palo Alto
country: United States
facility: Palo Alto Medical Research Foundation (Sutter Health)
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente
state: California
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Reno
country: United States
facility: Reno Orthopaedic Center
state: Nevada
city: New York
country: United States
facility: Kenneth Mroczek, MD-NYU
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania Health Systems-PA Foot and Ankle Surgeons
state: Pennsylvania
city: Dallas
country: United States
facility: Center for Foot and Ankle Restoration
state: Texas
Study officials:
affiliation: Stryker Nordic
name: Stefan Maartense, MD
role: STUDY_DIRECTOR
References: