NCT04630262

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

15 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
1.5 years until next milestone

Study Start

First participant enrolled

May 9, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

February 3, 2025

Completed
Last Updated

March 4, 2025

Status Verified

March 1, 2025

Enrollment Period

11 months

First QC Date

October 28, 2020

Results QC Date

January 25, 2024

Last Update Submit

March 3, 2025

Conditions

Osteoarthritis of the Knee

Keywords

OsteoarthritisPost-traumatic arthritisFailed total kneeKneeTotal knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • One Year Functional Responder Rate of First 225 Subjects

    Functional Responder Rate with an Objective Performance Criteria of 85% as measured by the KOOS questionnaire for the first 225 tibia

    through study completion, up to 10 months

Secondary Outcomes (32)

  • Measure of Knees With Adverse Events

    Through study completion, up to 10 months

  • Mean Number of Adverse Events Per Knee for Knees With Reported AEs

    Through study completion, up to 10 months

  • Measure of Knees With Device Deficiencies

    Through study completion, up to 10 months

  • Mean Number of Device Deficiencies Per Knee

    Through study completion, up to 10 months

  • One Year Functional Responder Rate All Subjects

    Through study completion, up to 10 months.

  • +27 more secondary outcomes

Study Arms (2)

ATTUNE Cementless CR Fixed Bearing

ACTIVE COMPARATOR

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

Device: ATTUNE Cementless CR Fixed Bearing

ATTUNE Cementless PS Fixed Bearing

ACTIVE COMPARATOR

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

Device: ATTUNE Cementless PS Fixed Bearing

Interventions

ATTUNE Cementless CR Fixed BearingDEVICE

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

ATTUNE Cementless CR Fixed Bearing
ATTUNE Cementless PS Fixed BearingDEVICE

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

ATTUNE Cementless PS Fixed Bearing

Eligibility Criteria

Age22 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive.
  • 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.
  • 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.
  • Subject is currently not bedridden.
  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Orthopaedic Specialty Institute

Irvine, California, 92618, United States

Location

Coastal Orthopedics

Bradenton, Florida, 34209, United States

Location

Florida Orthopaedic Associates

DeLand, Florida, 32720, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

American Hip Institute & Orthopedic Specialists

Chicago, Illinois, 60018, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Johns Hopkins Orthpaedic Surgery

Baltimore, Maryland, 21044, United States

Location

Towson Orthopaedic Associates

Baltimore, Maryland, 21204, United States

Location

Rubin Institute for Advanced Orthopedics

Baltimore, Maryland, 21215, United States

Location

Orthopaedic Associates of Michigan

Grand Rapids, Michigan, 49525, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Mercy Clinic Springfield

Ozark, Missouri, 65721, United States

Location

University Orthopaedic Associates, LLC

Somerset, New Jersey, 08873, United States

Location

Orlin & Cohen Orthopedics

Garden City, New York, 11530, United States

Location

Anderson Clinic

Alexandria, Virginia, 22306, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Limitations and Caveats

The primary/secondary endpoint analyses were not conducted due to early termination of the clinical study. Due to early study closure and the limited amount of post-operative clinical evidence collected during this clinical investigation, limited conclusions can be made regarding the overall safety and performance of the ATTUNE AFFIXIUM Tibial Base. Further clinical data collection and analysis are required.

Results Point of Contact

Title
Kelly Francher, Staff Clinical Research Scientist
Organization
DePuy Synthes
kfranche@its.jnj.com
574-241-6581

Study Officials

  • Allyson Morris

    DePuy Synthes

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: ATTUNE Cementless Fixed Bearing
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 16, 2020

Study Start

May 9, 2022

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

March 4, 2025

Results First Posted

February 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Shared Documents
STUDY PROTOCOL
Time Frame
Study Protocol will be immediately available.
Access Criteria
There are no additional qualifying criteria for access to the study protocol.
More information

Locations

US(15)