2-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System (STAR) Ankle Under Actual Conditions of Use (STAR 2 PAS)

Encore Medical

Status

Completed

Conditions

Post Traumatic Arthritis

Osteoarthritis

Primary Arthrosis

Rheumatoid Arthritis

Treatments

Device: Scandinavian Total Ankle Replacement System (STAR Ankle)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01284283

STAR 2 Year

Details and patient eligibility

About

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

Full 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.

Enrollment

102 patients

Sex

All

Volunteers

No Healthy Volunteers

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