ATTUNE Single-Use Instrumentation vs. ATTUNE Reusable Instrumentation in Primary Total Knee Arthroplasty

NCT ID: NCT02574312

Last Updated: 2020-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-01
• Study Completion Date: 2019-03-28

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.

Detailed Description

This study is designed as comparative, sequential, non-randomized, multi-center investigation.

Up to four sites will recruit approximately 88 subjects. Each site is expected to implant the ATTUNE primary cemented total knee in approximately 22 subjects. The sequential design requires all ATTUNE TKA with reusable instruments be completed before doing any ATTUNE TKA with single use instruments.

The mechanical axis alignment will be assessed at the 3 month follow-up by independent radiographic review.

Conditions

Osteoarthritis; Post-traumatic Arthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TKA with RUI

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).

Group Type: ACTIVE_COMPARATOR

ATTUNE TKA with ATTUNE RUI

Intervention Type: DEVICE

ATTUNE TKA with ATTUNE RUI

TKA with SUI

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).

Group Type: EXPERIMENTAL

ATTUNE TKA with ATTUNE SUI

Intervention Type: DEVICE

ATTUNE TKA with ATTUNE SUI

Interventions

ATTUNE TKA with ATTUNE RUI

ATTUNE TKA with ATTUNE RUI

Intervention Type: DEVICE

ATTUNE TKA with ATTUNE SUI

ATTUNE TKA with ATTUNE SUI

Intervention Type: DEVICE

Other Intervention Names

ATTUNE Intuition; ATTUNE SOLO

Eligibility Criteria

Inclusion Criteria

1. Subjects with severely painful and/or severely disabling Non-inflammatory Degenerative Joint Disease (NIDJD) resulting from osteoarthritis (OA) or post-traumatic arthritis.

2. Subject is male or female and between the ages of 22 and 80 years old, inclusive.

3. 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.

4. Subject, who, in the opinion of the Investigator, is suitable for implantation using either RUI or SUI instrumentation.

5. Subject is able to speak and read English to facilitate comprehension of the Informed Consent Document.

6. 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.

7. 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.

Exclusion Criteria

1. The Subject has, in the opinion of the Investigator, a severe deformity that will hinder achieving a mechanical axis alignment target of 0° ± 3°.

2. The Subject has, in the opinion of the Investigator, an existing condition that would compromise their participation and follow-up in this study.

3. The Subject has, in the opinion of the Investigator, a flexion deformity that will not allow for 0° extension postoperatively.

4. The Subject is a woman who is pregnant or lactating.

5. 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.

6. The Subject has participated in a clinical investigation with an investigational product in the last 3 months.

7. The Subject is currently involved in any personal injury litigation, medical-legal or worker's compensations claims.

8. 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.

9. The Subject presents with ankylosis of the hip joint on the side to be treated.

10. The Subject had a contralateral TKA and that knee was previously entered into the study.

11. The Subject requires simultaneous bilateral total knee replacements.

12. 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.

13. The Subject requires a device not specified in the protocol or the surgeon determines that the ATTUNE Knee System is not a suitable treatment.

• 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

Verdonna Huey, MS,BSN,CCRP

Role: STUDY_DIRECTOR

DePuy Synthes

Locations

Scripps Clinic Torrey Pines

La Jolla, California, United States

Geisinger Wyoming Valley

Wilkes-Barre, Pennsylvania, United States

Spire Liverpool Hospital

Liverpool, , United Kingdom

Clifton Park Hospital

York, , United Kingdom

Countries

United States; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

10002

Identifier Type: -

Identifier Source: org_study_id