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

Purpose

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

Condition	Intervention
Primary Arthrosis Post Traumatic Arthritis Rheumatoid Arthritis Osteoarthritis	Device: Scandinavian Total Ankle Replacement System (STAR Ankle)


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment
Official Title:	2-Year Post-Approval Study to Investigate the STAR Ankle Under Actual Conditions of Use

Resource links provided by NLM:

Genetics Home Reference related topics: rheumatoid arthritis

U.S. FDA Resources

Further study details as provided by Stryker Trauma GmbH:

Primary Outcome Measures:

Primary Endpoint [ Time Frame: 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:

Secondary Endpoints [ Time Frame: 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


Estimated Enrollment:	98
Study Start Date:	November 2009
Estimated Study Completion Date:	December 2020
Estimated Primary Completion Date:	March 2020 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single Device: Scandinavian Total Ankle Replacement System (STAR Ankle)	Device: Scandinavian Total Ankle Replacement System (STAR Ankle) For total ankle replacement Other Name: STAR

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


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284283

Contacts


Contact: Rebecca Gibson		rebecca.gibson@stryker.com

Locations


United States, California
Palo Alto Medical Research Foundation (Sutter Health)	Recruiting
Palo Alto, California, United States
Contact: Shannon Rush, DPM
Principal Investigator: Shannon Rush, DPM
Kaiser Permanente	Active, not recruiting
San Francisco, California, United States, 94118
United States, Michigan
William Beaumont Hospital	Recruiting
Royal Oak, Michigan, United States, 48085
Contact: Kristy McCandlish kmccandlish@beaumont.edu
Principal Investigator: Allen Grant, MD
United States, Nevada
Reno Orthopaedic Center	Recruiting
Reno, Nevada, United States
Contact: Sara DePaoli sdepaoli@Renoortho.com
Principal Investigator: Gregg Lundeen, MD
Sub-Investigator: Scott Whitlow, MD
United States, New York
Kenneth Mroczek, MD-NYU	Recruiting
New York, New York, United States, 10003
Contact: Ariel Aponte Ariel.Aponte@nyumc.org
Principal Investigator: Kenneth Mroczek, MD
Sub-Investigator: Cary Chapman, MD
Sub-Investigator: Steven Sheskier, MD
United States, Pennsylvania
University of Pennsylvania Health Systems-PA Foot and Ankle Surgeons	Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Aliaksei Basatski Aliaksei.Basatski@uphs.upenn.edu
Principal Investigator: Keith L Wapner, MD
Sub-Investigator: David Farber, MD
Sub-Investigator: Wen Chao, MD
United States, Texas
Center for Foot and Ankle Restoration	Completed
Dallas, Texas, United States, 75231

Sponsors and Collaborators

Stryker Trauma GmbH

Investigators


Study Director:	Richard Jay, DPM	Stryker Nordic

More Information


Responsible Party:	Stryker Trauma GmbH
ClinicalTrials.gov Identifier:	NCT01284283 History of Changes
Other Study ID Numbers:	STAR 2 Year
Study First Received:	November 2, 2010
Last Updated:	July 25, 2017

Keywords provided by Stryker Trauma GmbH:


Arthrosis Rheumatoid Arthrosis Arthritic joint Rheumatoid Arthritis Osteoarthritis

Additional relevant MeSH terms:


Arthritis Osteoarthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases	Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases

ClinicalTrials.gov processed this record on August 16, 2017

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