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

Rheumatoid Arthritis Clinical Trial

— STAR 2 PAS  

Official title:

2-Year Post-Approval Study to Investigate the STAR Ankle Under Actual Conditions of Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284283
• Other study ID #: STAR 2 Year
• Status: Completed
• Phase: N/A
• Start date: November 2009
• Est. completion date: March 2021

Study information

• Verified date: July 2022
• Source: Encore Medical, L.P.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Joint Diseases
• Osteoarthritis
• Post Traumatic Arthritis
• Primary Arthrosis
• Rheumatoid Arthritis

Intervention

Device:
• Scandinavian Total Ankle Replacement System (STAR Ankle)
For total ankle replacement

Locations

Country	Name	City	State
United States	Center for Foot and Ankle Restoration	Dallas	Texas
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Kenneth Mroczek, MD-NYU	New York	New York
United States	Palo Alto Medical Research Foundation (Sutter Health)	Palo Alto	California
United States	University of Pennsylvania Health Systems-PA Foot and Ankle Surgeons	Philadelphia	Pennsylvania
United States	The CORE Institute	Phoenix	Arizona
United States	Reno Orthopaedic Center	Reno	Nevada
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Kaiser Permanente	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Encore Medical, L.P.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Endpoint	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: = 40 point improvement in total Buechel-Pappas Scale score; No device failures; Radiographic success (no clinically significant radiographic evidence of loosening, tilting or migration > 4mm); No major complications	2 years
Secondary	Secondary Endpoints	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	2 years