ACTIVE_NOT_RECRUITING

ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population

Conditions

Primary Knee Arthroplasty complex primary, deformity, ligamentous laxity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component in complex primary total knee arthroplasty.

Official Title

Multi-Center Clinical Evaluation of the ATTUNE Revision System in Complex Primary Total Knee Arthroplasty

Quick Facts

Study Start:2017-09-19

Study Completion:2028-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03153449

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive. 2. The decision to have knee replacement with the study device is regardless of the research. 3. The devices are to be used according to the approved indications. 4. Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor 5. Subject is currently not bedridden. 6. Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures. 7. Subject is able to read, and comprehend the Informed Consent Document as well as complete the required PROMs in either English or one of the available translations. 8. Subject has not been diagnosed with an inflammatory arthritis (including gout, rheumatoid, psoriatic etc.)	1. The Subject is a woman who is pregnant or lactating. 2. Contralateral knee has already been enrolled in this study. If the Investigator plans to treat a potential study subject with either simultaneous (two (2) knees in one (1) surgical setting) or staged bilateral TKA, then this subject may be enrolled; however, only the first knee may be enrolled into this study. 3. Subject had a contralateral amputation. 4. Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement) or primary TKA in affected knee. 5. Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA. 6. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months. 7. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims. 8. Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect his/her ability to complete patient reported questionnaires or be compliant with follow-up requirements. 9. Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia. 10. Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing activities (e.g., muscular dystrophy, multiple sclerosis, Charcot disease). 11. Subject has a medical condition with less than five (5) years life expectancy as determined by the Investigator. 12. Subject has been diagnosed with an inflammatory arthritis (including uncontrolled gout, rheumatoid, psoriatic etc.).

Inclusion Criteria

Exclusion Criteria

1. Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive.
2. The decision to have knee replacement with the study device is regardless of the research.
3. The devices are to be used according to the approved indications.
4. Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor
5. Subject is currently not bedridden.
6. Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures.
7. Subject is able to read, and comprehend the Informed Consent Document as well as complete the required PROMs in either English or one of the available translations.
8. Subject has not been diagnosed with an inflammatory arthritis (including gout, rheumatoid, psoriatic etc.)

1. The Subject is a woman who is pregnant or lactating.
2. Contralateral knee has already been enrolled in this study. If the Investigator plans to treat a potential study subject with either simultaneous (two (2) knees in one (1) surgical setting) or staged bilateral TKA, then this subject may be enrolled; however, only the first knee may be enrolled into this study.
3. Subject had a contralateral amputation.
4. Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement) or primary TKA in affected knee.
5. Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA.
6. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
7. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
8. Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect his/her ability to complete patient reported questionnaires or be compliant with follow-up requirements.
9. Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
10. Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing activities (e.g., muscular dystrophy, multiple sclerosis, Charcot disease).
11. Subject has a medical condition with less than five (5) years life expectancy as determined by the Investigator.
12. Subject has been diagnosed with an inflammatory arthritis (including uncontrolled gout, rheumatoid, psoriatic etc.).

Contacts and Locations

Principal Investigator

Grant Jamgochian

STUDY_DIRECTOR

Sponsor GmbH

Study Locations (Sites)

Scripps Clinic Torrey Pines

San Diego, California, 92037

United States

Colorado Joint Replacement

Denver, Colorado, 80210

United States

Orthopaedic Center of the Rockies

Fort Collins, Colorado, 80525

United States

Orthopedic Partners

Niantic, Connecticut, 06357

United States

Florida Orthopedic Associates

DeLand, Florida, 32720

United States

Arthroplasty Foundation

Louisville, Kentucky, 40215

United States

University of Mississippi Medical Center

Jackson, Mississippi, 39216

United States

Mery Hospital

Ozark, Missouri, 65721

United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756

United States

Rothman Institute

Egg Harbor, New Jersey, 08234

United States

UNC Orthopaedics

Chapel Hill, North Carolina, 27514

United States

OrthoCarolina Hip and Knee Center

Charlotte, North Carolina, 28207

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210

United States

Southern Joint Replacement Institute

Nashville, Tennessee, 37203

United States

Texas Institute for Hip & Knee Surgery

Austin, Texas, 78751

United States

Fondren Orthopedic Group

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: DePuy Orthopaedics

Grant Jamgochian, STUDY_DIRECTOR, Sponsor GmbH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-09-19

Study Completion Date2028-06-30

Study Record Updates

Study Start Date2017-09-19

Study Completion Date2028-06-30

Terms related to this study

Keywords Provided by Researchers

complex primary, deformity, ligamentous laxity

Additional Relevant MeSH Terms

Primary Knee Arthroplasty