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

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis; Osteoarthritis; Primary Arthrosis; Post Traumatic Arthritis
• Interventions: Device: Scandinavian Total Ankle Replacement System (STAR Ankle)

• Registration Number: NCT01284283
• Lead Sponsor: Encore Medical, L.P.

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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-11-02
• Study First Submitted QC: 2011-01-25
• Study First Posted: 2011-01-26
• Primary Completion: 2021-03
• Study Completion: 2021-03
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single	Scandinavian Total Ankle Replacement System (STAR Ankle)	Device: Scandinavian Total Ankle Replacement System (STAR Ankle)

Primary Outcome Measures

Name	Time	Method
Primary Endpoint	2 years	The primary objective of this study is to examine the performance of the STAR™ Ankle under actual conditions of use, employing the approved instructions for use, labeling, and instrumentation. The principal endpoint consists of evaluating the safety and effectiveness of the STAR™ Ankle. Overall patient success is defined as: 1. ≥ 40 point improvement in total Buechel-Pappas Scale score; 2. No device failures; 3. Radiographic success (no clinically significant radiographic evidence of loosening, tilting or migration \> 4mm); 4. No major complications

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoints	2 years	In addition to the principal endpoint, information on the following efficacy outcomes will be assessed: * Total Buechel-Pappas Scale score; * Pain Visual Analog Scale; * Quality of Life; * American Orthopaedic Foot \& Ankle Society (AOFAS) Ankle Hindfoot Scale; The following radiographic endpoints will be assessed by anterior/posterior and lateral radiographs by the treating surgeon and an independent radiographic reviewer: * Radiolucency; * Migration

Trial Locations

Locations (9)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

Center for Foot and Ankle Restoration; 🇺🇸 Dallas, Texas, United States

Kaiser Permanente; 🇺🇸 San Francisco, California, United States

Palo Alto Medical Research Foundation (Sutter Health); 🇺🇸 Palo Alto, California, United States

Kenneth Mroczek, MD-NYU; 🇺🇸 New York, New York, United States

The CORE Institute; 🇺🇸 Phoenix, Arizona, United States

University of Pennsylvania Health Systems-PA Foot and Ankle Surgeons; 🇺🇸 Philadelphia, Pennsylvania, United States

Reno Orthopaedic Center; 🇺🇸 Reno, Nevada, United States