ATTUNE Cementless FB Tibial Base Clinical Study

NCT ID: NCT04630262

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-09
• Study Completion Date: 2023-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Osteoarthritis of the Knee

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ATTUNE Cementless CR Fixed Bearing

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

Group Type: ACTIVE_COMPARATOR

ATTUNE Cementless CR Fixed Bearing

Intervention Type: DEVICE

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

ATTUNE Cementless PS Fixed Bearing

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

Group Type: ACTIVE_COMPARATOR

ATTUNE Cementless PS Fixed Bearing

Intervention Type: DEVICE

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

Interventions

ATTUNE Cementless CR Fixed Bearing

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

Intervention Type: DEVICE

ATTUNE Cementless PS Fixed Bearing

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allyson Morris

Role: STUDY_DIRECTOR

DePuy Synthes

Locations

Orthopaedic Specialty Institute

Irvine, California, United States

Coastal Orthopedics

Bradenton, Florida, United States

Florida Orthopaedic Associates

DeLand, Florida, United States

University of Florida

Gainesville, Florida, United States

American Hip Institute & Orthopedic Specialists

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Johns Hopkins Orthpaedic Surgery

Baltimore, Maryland, United States

Towson Orthopaedic Associates

Baltimore, Maryland, United States

Rubin Institute for Advanced Orthopedics

Baltimore, Maryland, United States

Orthopaedic Associates of Michigan

Grand Rapids, Michigan, United States

University of Missouri

Columbia, Missouri, United States

Mercy Clinic Springfield

Ozark, Missouri, United States

University Orthopaedic Associates, LLC

Somerset, New Jersey, United States

Orlin & Cohen Orthopedics

Garden City, New York, United States

Anderson Clinic

Alexandria, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

DSJ_2019_05

Identifier Type: -

Identifier Source: org_study_id