NCT02574312

Brief Summary

This post-marketing investigation will evaluate the mechanical axis alignment achieved with the ATTUNE Single-Use Instrumentation (SUI) as compared to the mechanical axis alignment achieved with the ATTUNE Reusable Instrumentation (RUI) in primary cemented Total Knee Arthroplasty.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
completed

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

September 30, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 12, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

April 9, 2020

Completed
Last Updated

April 9, 2020

Status Verified

March 1, 2020

Enrollment Period

3.5 years

First QC Date

September 30, 2015

Results QC Date

March 27, 2020

Last Update Submit

March 27, 2020

Conditions

OsteoarthritisPost-traumatic Arthritis

Keywords

Mechanical Axis AlignmentKnee Arthroplasty, Total

Outcome Measures

Primary Outcomes (1)

  • Difference in Absolute Mechanical Axis Alignment Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation

    3 Months Post Surgery

Secondary Outcomes (5)

  • Femoral Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation

    3 Months Post Surgery

  • Tibial Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation

    3 Months Post Surgery

  • Femoral Component Flexion Angle Between Subjects Operated on With RUI and SUI Instrumentation

    3 Months Post Surgery

  • Posterior Tibial Slope Between Subjects Operated on With RUI and SUI Instrumentation

    3 Months Post Surgery

  • Number of Participants With Treatment-related Adverse Events

    3 Months Post Surgery

Study Arms (2)

TKA with RUI

ACTIVE COMPARATOR

44 Subjects will receive TKA with RUI per their study doctor's standard of care. These 44 subjects will receive the TKA using Reusable instruments (RUI).

Device: ATTUNE TKA with ATTUNE RUI

TKA with SUI

EXPERIMENTAL

44 Subjects will receive TKA with SUI per their study doctor's standard of care. These 44 subjects will receive the TKA using Single Use Instruments (SUI).

Device: ATTUNE TKA with ATTUNE SUI

Interventions

ATTUNE TKA with ATTUNE RUIDEVICE

ATTUNE TKA with ATTUNE RUI

Also known as: ATTUNE Intuition
TKA with RUI
ATTUNE TKA with ATTUNE SUIDEVICE

ATTUNE TKA with ATTUNE SUI

Also known as: ATTUNE SOLO
TKA with SUI

Eligibility Criteria

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

You may qualify if:

  • Subjects with severely painful and/or severely disabling Non-inflammatory Degenerative Joint Disease (NIDJD) resulting from osteoarthritis (OA) or post-traumatic arthritis.
  • Subject is male or female and between the ages of 22 and 80 years old, inclusive.
  • Subject requires a primary total knee replacement and is considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol.
  • Subject, who, in the opinion of the Investigator, is suitable for implantation using either RUI or SUI instrumentation.
  • Subject is able to speak and read English to facilitate comprehension of the Informed Consent Document.
  • Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy Synthes Joint Reconstruction.
  • 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.

You may not qualify if:

  • The Subject has, in the opinion of the Investigator, a severe deformity that will hinder achieving a mechanical axis alignment target of 0° ± 3°.
  • The Subject has, in the opinion of the Investigator, an existing condition that would compromise their participation and follow-up in this study.
  • The Subject has, in the opinion of the Investigator, a flexion deformity that will not allow for 0° extension postoperatively.
  • The Subject is a woman who is pregnant or lactating.
  • The 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 follow-up care or treatment outcomes.
  • The Subject has participated in a clinical investigation with an investigational product in the last 3 months.
  • The Subject is currently involved in any personal injury litigation, medical-legal or worker's compensations claims.
  • The Subject has previous prosthetic knee replacement (any type including unicompartmental, total knee arthroplasty, patellofemoral arthroplasty or ipsilateral UTO/HTO) of the affected knee or a previous patellectomy.
  • The Subject presents with ankylosis of the hip joint on the side to be treated.
  • The Subject had a contralateral TKA and that knee was previously entered into the study.
  • The Subject requires simultaneous bilateral total knee replacements.
  • Any case in which Computer-Assisted Surgery (CAS) or TruMatch (or any other type of Custom Patient Instruments) is to be used, or any additional instrumentation are to be used for bone resections that are not provided as part of the ATTUNE RUI or SUI Instrument kits.
  • The Subject requires a device not specified in the protocol or the surgeon determines that the ATTUNE Knee System is not a suitable treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Scripps Clinic Torrey Pines

La Jolla, California, 92037, United States

Location

Geisinger Wyoming Valley

Wilkes-Barre, Pennsylvania, 18702, United States

Location

Spire Liverpool Hospital

Liverpool, L18 1HQ, United Kingdom

Location

Clifton Park Hospital

York, YO30 5RA, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Kirstin Cosgrove
Organization
DePuy Ortho Joint US
kcosgro1@its.jnj.com
800-827-7003

Study Officials

  • Verdonna Huey, MS,BSN,CCRP

    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
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 12, 2015

Study Start

October 1, 2015

Primary Completion

March 28, 2019

Study Completion

March 28, 2019

Last Updated

April 9, 2020

Results First Posted

April 9, 2020

Record last verified: 2020-03

Locations

US(2)GB(2)