Arthritis Trial Finder

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

Study Purpose

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

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT01284283

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Stryker Trauma GmbH

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Richard Jay, DPM
Principal Investigator Affiliation Stryker Nordic

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Primary Arthrosis, Post Traumatic Arthritis, Rheumatoid Arthritis, Osteoarthritis
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Center for Foot and Ankle Restoration, Dallas, Texas

Status

Completed

Address

Center for Foot and Ankle Restoration

Dallas, Texas, 75231

Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania Health Systems-PA Foot and Ankle Surgeons

Philadelphia, Pennsylvania, 19106

Site Contact

Aliaksei Basatski

Aliaksei.Basatski@uphs.upenn.edu

Kenneth Mroczek, MD-NYU, New York, New York

Status

Recruiting

Address

Kenneth Mroczek, MD-NYU

New York, New York, 10003

Site Contact

Ariel Aponte

Ariel.Aponte@nyumc.org

Reno Orthopaedic Center, Reno, Nevada

Status

Recruiting

Address

Reno Orthopaedic Center

Reno, Nevada,

Site Contact

Sara DePaoli

sdepaoli@Renoortho.com

William Beaumont Hospital, Royal Oak, Michigan

Status

Recruiting

Address

William Beaumont Hospital

Royal Oak, Michigan, 48085

Site Contact

Kristy McCandlish

kmccandlish@beaumont.edu

Kaiser Permanente, San Francisco, California

Status

Completed

Address

Kaiser Permanente

San Francisco, California, 94118

Palo Alto, California

Status

Recruiting

Address

Palo Alto Medical Research Foundation (Sutter Health)

Palo Alto, California,

Site Contact

Shannon Rush, DPM

Cedars Sinai Medical Center, Los Angeles, California

Status

Recruiting

Address

Cedars Sinai Medical Center

Los Angeles, California, 90048

Site Contact

David Thordarson

The CORE Institute, Phoenix, Arizona

Status

Recruiting

Address

The CORE Institute

Phoenix, Arizona, 85023

Site Contact

Susan Mauro, RN

susan.mauro@thecoreinstitute.com

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