2-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System (STAR) Ankle Under Actual Conditions of Use (STAR 2 PAS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01284283 |
Recruitment Status :
Active, not recruiting
First Posted : January 26, 2011
Last Update Posted : November 6, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Primary Arthrosis Post Traumatic Arthritis Rheumatoid Arthritis Osteoarthritis | Device: Scandinavian Total Ankle Replacement System (STAR Ankle) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 102 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 2-Year Post-Approval Study to Investigate the STAR Ankle Under Actual Conditions of Use |
Study Start Date : | November 2009 |
Estimated Primary Completion Date : | March 2021 |
Estimated Study Completion Date : | March 2021 |

Arm | Intervention/treatment |
---|---|
Single
Device: Scandinavian Total Ankle Replacement System (STAR Ankle)
|
Device: Scandinavian Total Ankle Replacement System (STAR Ankle)
For total ankle replacement
Other Name: STAR |
- 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 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

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, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284283
United States, Arizona | |
The CORE Institute | |
Phoenix, Arizona, United States, 85023 | |
United States, California | |
Cedars Sinai Medical Center | |
Los Angeles, California, United States, 90048 | |
Palo Alto Medical Research Foundation (Sutter Health) | |
Palo Alto, California, United States, 94301 | |
Kaiser Permanente | |
San Francisco, California, United States, 94118 | |
United States, Michigan | |
William Beaumont Hospital | |
Royal Oak, Michigan, United States, 48085 | |
United States, Nevada | |
Reno Orthopaedic Center | |
Reno, Nevada, United States, 89503 | |
United States, New York | |
Kenneth Mroczek, MD-NYU | |
New York, New York, United States, 10003 | |
United States, Pennsylvania | |
University of Pennsylvania Health Systems-PA Foot and Ankle Surgeons | |
Philadelphia, Pennsylvania, United States, 19106 | |
United States, Texas | |
Center for Foot and Ankle Restoration | |
Dallas, Texas, United States, 75231 |
Study Director: | Stefan Maartense, MD | Stryker Nordic |
Responsible Party: | Stryker Trauma GmbH |
ClinicalTrials.gov Identifier: | NCT01284283 |
Other Study ID Numbers: |
STAR 2 Year |
First Posted: | January 26, 2011 Key Record Dates |
Last Update Posted: | November 6, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Arthrosis Rheumatoid Arthrosis Arthritic Joint |
Rheumatoid Arthritis Osteoarthritis Total Ankle Replacement |
Arthritis Osteoarthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |