ATTUNE Cementless FB Tibial Base Clinical Study

Study Purpose

This is a prospective, multi-center, non-randomized, single arm observational study. The primary objective of this clinical investigation is to evaluate functional responder rates with an objective performance criteria (OPC) of 85% as measured by the KOOS questionnaire for the first 225 tibia (CR FB and PS FB combined) implanted with the ATTUNE Cementless FB tray (primary and revision procedures) and will be analyzed when these patients have passed the 1 year preferred post-op window.

Recruitment Criteria

Accepts Healthy Volunteers

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

No
Study Type

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.

Interventional
Eligible Ages 22 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive. 2. Subject has a severely painful knee and/or impaired knee function resulting from osteoarthritis, post-traumatic arthritis, or a failed previous implant provided that adequate bone is present. 3. 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. 4. Subject is currently not bedridden. 5. 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. 6. 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.

Exclusion Criteria:

  • - a) The Subject is a woman who is pregnant or lactating.
b) Contralateral knee has already been enrolled in this study . c) Revision knee that was previously enrolled in the study as a primary knee (ipsilateral). d) Subject has participated in a clinical study with an investigational product (drug or device) in the last two
  • (2) years.
e) Subject has had surgery on their contralateral knee within six
  • (6) months of study enrolment or has surgery planned on their contralateral knee less than six (6) months of the study surgery.
f) Subject is suffering from inflammatory arthritis in any joint (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.). g) Active local or systemic infection. h) Loss of bone or musculature, inadequate bone quality (e.g. severe osteoporosis), neuromuscular compromise or vascular deficiency at the bone site in the affected limb in sufficient degree to render the procedure unjustifiable (e.g. absence of musculoligamentous supporting structures that could lead to implant instability, joint neuropathy). i) Severe instability secondary to advanced loss of osteochondral structure or the absence of collateral ligament integrity. j) The inability to make bone cuts (e.g. inadequate bone stock) so as to assure correct component position, a firm press fit, and intimate apposition of the cut bone and prosthetic surfaces. k) Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims. l) Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last five 5 years) or has a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.

Trial Details

Trial ID:

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.

NCT04630262
Phase

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.

N/A
Lead Sponsor

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

DePuy Orthopaedics
Principal Investigator

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

Allyson Morris
Principal Investigator Affiliation DePuy Synthes
Agency Class

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

Industry
Overall Status Recruiting
Countries United States
Conditions

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

Osteoarthritis of the Knee
Additional Details

The primary objective of this clinical investigation is to evaluate functional responder rates with an objective performance criteria (OPC) of 85% as measured by the KOOS questionnaire for the first 225 tibia (CR FB and PS FB combined) implanted with the ATTUNE Cementless FB tray (primary and revision procedures) and will be analyzed when these patients have passed the 1 year preferred post-op window. Study success will be determined using the primary TKA (CR FB and PS FB combined) analysis group. The secondary objectives of this study are to establish the surgical effectiveness of the ATTUNE Cementless Tibial Base by evaluating type and frequency of Adverse Events and Device Deficiencies, functional responder rates with an objective performance criteria (OPC) of 85% as measured by the KOOS questionnaire for all subjects (CR FB and PS FB combined) at the 1-year timepoint, the change from preoperative baseline to the 6-week, 6-month, 1-year, 2-year and 5-year timepoints in functional outcomes and quality of life assessments, as measured using additional patient reported outcomes measures (PROMS), implant survivorship of the ATTUNE Cementless FB Tibial base using Kaplan-Meier survival analysis at 1, 2 and 5-year timepoints, and investigator-conducted radiographic analysis of the tibial and patellar components at 6 weeks/6 months 1, 2 and 5 years after surgery.

Arms & Interventions

Arms

Active Comparator: ATTUNE Cementless CR Fixed Bearing

Subjects enrolled who undergo TKA with the ATTUNE Cementless Fixed Bearing Cruciate Retaining Configuration.

Active Comparator: ATTUNE Cementless PS Fixed Bearing

Subjects enrolled who undergo TKA with the ATTUNE Cementless Fixed Bearing Posterior Stabilizing Configuration.

Interventions

Device: - ATTUNE Cementless CR Fixed Bearing

Subjects Implanted with the ATTUNE Cementless Femoral, Cementless Tibia, and CR or (Medial Stabilized) MS Tibial Insert.

Device: - ATTUNE Cementless PS Fixed Bearing

Subjects Implanted with the ATTUNE Cementless Femoral, Cementless Tibia, and PS Tibial Insert.

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.

Orthopaedic Specialty Institute, Irvine, California

Status

Recruiting

Address

Orthopaedic Specialty Institute

Irvine, California, 92618

Site Contact

Teddy Quilligan

[email protected]

714-937-2144

Fort Collins, Colorado

Status

Withdrawn

Address

Orthopaedic and Spine Center of the Rockies

Fort Collins, Colorado, 80525

Coastal Orthopedics, Bradenton, Florida

Status

Not yet recruiting

Address

Coastal Orthopedics

Bradenton, Florida, 34209

Site Contact

Christina Scheuerman

[email protected]

513-520-1459

Florida Orthopaedic Associates, DeLand, Florida

Status

Recruiting

Address

Florida Orthopaedic Associates

DeLand, Florida, 32720

Site Contact

Diane Martin, RN

[email protected]

386-734-3710

University of Florida, Gainesville, Florida

Status

Recruiting

Address

University of Florida

Gainesville, Florida, 32611

Site Contact

Emilie Miley

[email protected]

352-273-7361

Chicago, Illinois

Status

Recruiting

Address

American Hip Institute & Orthopedic Specialists

Chicago, Illinois, 60018

Site Contact

Dina Vavarutsos

[email protected]

574-241-6581

Loyola University Medical Center, Maywood, Illinois

Status

Recruiting

Address

Loyola University Medical Center

Maywood, Illinois, 60153

Site Contact

Maria Chavez, MSN, RN, CNL

[email protected]

574-241-6581

Franciscan Alliance, Inc., Carmel, Indiana

Status

Withdrawn

Address

Franciscan Alliance, Inc.

Carmel, Indiana, 02767

Johns Hopkins Orthpaedic Surgery, Baltimore, Maryland

Status

Recruiting

Address

Johns Hopkins Orthpaedic Surgery

Baltimore, Maryland, 21044

Site Contact

Amil Agarwal

[email protected]

574-241-6581

Towson Orthopaedic Associates, Baltimore, Maryland

Status

Recruiting

Address

Towson Orthopaedic Associates

Baltimore, Maryland, 21204

Site Contact

Danielle Chapman

[email protected]

410-490-6623

Rubin Institute for Advanced Orthopedics, Baltimore, Maryland

Status

Recruiting

Address

Rubin Institute for Advanced Orthopedics

Baltimore, Maryland, 21215

Site Contact

Taj-Jamal Andrews, MD, MBA

[email protected]

410-601-9592

Orthopaedic Associates of Michigan, Grand Rapids, Michigan

Status

Recruiting

Address

Orthopaedic Associates of Michigan

Grand Rapids, Michigan, 49525

Site Contact

Daisy Gomez-de Leon

[email protected]

616-459-7101 #2021

University of Missouri, Columbia, Missouri

Status

Recruiting

Address

University of Missouri

Columbia, Missouri, 65212

Site Contact

Bryce Fletcher

[email protected]

573-884-1248

Mercy Clinic Springfield, Ozark, Missouri

Status

Not yet recruiting

Address

Mercy Clinic Springfield

Ozark, Missouri, 65721

Site Contact

Diana Connelly, BHS, RRT, CCRC

[email protected]

417-820-7493

University Orthopaedic Associates, LLC, Somerset, New Jersey

Status

Recruiting

Address

University Orthopaedic Associates, LLC

Somerset, New Jersey, 08873

Site Contact

Patricia Seuffert, MS, APN

[email protected]

908-239-0301

Orlin & Cohen Orthopedics, Garden City, New York

Status

Recruiting

Address

Orlin & Cohen Orthopedics

Garden City, New York, 11530

Site Contact

Nadia Baichoo, CRC

[email protected]

646-641-8713

Providence Orthpaedic Research, Portland, Oregon

Status

Withdrawn

Address

Providence Orthpaedic Research

Portland, Oregon, 97225

Anderson Clinic, Alexandria, Virginia

Status

Recruiting

Address

Anderson Clinic

Alexandria, Virginia, 22306

Site Contact

Nancy Parks

[email protected]

574-241-6581