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2-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System (STAR) Ankle Under Actual Conditions of Use (STAR)
This study is currently recruiting participants.
Verified June 2017 by Stryker Trauma GmbH
Sponsor:
Stryker Trauma GmbH
Information provided by (Responsible Party):
Stryker Trauma GmbH
ClinicalTrials.gov Identifier:
NCT01284283
First received: November 2, 2010
Last updated: June 14, 2017
Last verified: June 2017
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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:
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:
- ≥ 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 [ 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
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) | Not yet recruiting |
| Palo Alto, California, United States | |
| Contact: Shannon Rush, DPM | |
| Principal Investigator: Shannon Rush, DPM | |
| Kaiser Permanente | Recruiting |
| San Francisco, California, United States, 94118 | |
| Contact: Eva Greenstein Eva.R.Greenstein@kp.org | |
| Contact: Alfonso Gutierrez alfonso.r.ramirez-gutierrez@kp.org | |
| Principal Investigator: John M Schuberth, DPM | |
| Sub-Investigator: Christy King, DPM | |
| 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: Brandon Eilberg Brandon.Eilberg@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 | Active, not recruiting |
| Dallas, Texas, United States, 75231 | |
Sponsors and Collaborators
Stryker Trauma GmbH
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: | June 14, 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 June 22, 2017