Back to results2-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System (STAR) Ankle Under Actual Conditions of Use (STAR 2 PAS)
Primary Purpose
Primary Arthrosis, Post Traumatic Arthritis, Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Scandinavian Total Ankle Replacement System (STAR Ankle)
Sponsored by
About this trial
This is an interventional treatment trial for Primary Arthrosis focused on measuring Arthrosis, Rheumatoid Arthrosis, Arthritic Joint, Rheumatoid Arthritis, Osteoarthritis, Total Ankle Replacement
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
Sites / Locations
- The CORE Institute
- Cedars Sinai Medical Center
- Palo Alto Medical Research Foundation (Sutter Health)
- Kaiser Permanente
- William Beaumont Hospital
- Reno Orthopaedic Center
- Kenneth Mroczek, MD-NYU
- University of Pennsylvania Health Systems-PA Foot and Ankle Surgeons
- Center for Foot and Ankle Restoration
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single
Arm Description
Device: Scandinavian Total Ankle Replacement System (STAR Ankle)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01284283
Brief Title
2-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System (STAR) Ankle Under Actual Conditions of Use
Acronym
STAR 2 PAS
Official Title
2-Year Post-Approval Study to Investigate the STAR Ankle Under Actual Conditions of Use
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2021 (Actual)
Study Completion Date
March 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Encore Medical, L.P.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Arthrosis, Post Traumatic Arthritis, Rheumatoid Arthritis, Osteoarthritis
Keywords
Arthrosis, Rheumatoid Arthrosis, Arthritic Joint, Rheumatoid Arthritis, Osteoarthritis, Total Ankle Replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single
Arm Type
Other
Arm Description
Device: Scandinavian Total Ankle Replacement System (STAR Ankle)
Intervention Type
Device
Intervention Name(s)
Scandinavian Total Ankle Replacement System (STAR Ankle)
Other Intervention Name(s)
STAR
Intervention Description
For total ankle replacement
Primary Outcome Measure Information:
Title
Primary Endpoint
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Secondary Endpoints
Description
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
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Maartense, MD
Organizational Affiliation
Stryker Nordic
Official's Role
Study Director
Facility Information:
Facility Name
The CORE Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Palo Alto Medical Research Foundation (Sutter Health)
City
Palo Alto
State/Province
California
ZIP/Postal Code
94301
Country
United States
Facility Name
Kaiser Permanente
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Reno Orthopaedic Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89503
Country
United States
Facility Name
Kenneth Mroczek, MD-NYU
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
University of Pennsylvania Health Systems-PA Foot and Ankle Surgeons
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Center for Foot and Ankle Restoration
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
2-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System (STAR) Ankle Under Actual Conditions of Use
We'll reach out to this number within 24 hrs