RSA RCT: Attune RP TKA Versus LCS RP TKA

NCT03101007 | Completed FDA Device

• 1 other identifier: 2017.0027
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

Brief Summary

The LCS Complete Cementless Knee by DePuy Synthes is a rotating platform knee replacement with a good clinical track record and good survival rates. The cementless ATTUNE Cruciate Sacrificing (CS) Rotating Platform Knee by DePuy Synthes has been designed to provide better range of motion and address the unstable feeling some patients experience during everyday activities, such as stair descent and bending. It is expected that the cementless ATTUNE Rotating Platform Knee will have regulatory approval early 2016. Patient inclusion will start after regular approval has been obtained. The objective of this study is to accurately assess and compare migration, clinical and radiological outcome and patient reported outcomes (PROMS) of two TKR prostheses: the Cementless ATTUNE Rotating Platform Cruciate Sacrificing Knee System and the LCS Complete Cementless Cruciate Sacrificing Knee System (rotating platform design), both by DePuy Synthes, Warsaw, Indiana, USA. In this single-blind, randomized non-inferiority trial, 32 patients with the ATTUNE Knee System and 32 patients with LCS Knee System will be included. The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for TKR surgery at the Department of Orthopaedics, Spaarne Gasthuis, Hoofddorp, The Netherlands. Annually 300 TKA procedures are performed in this department, of which about 95% is Osteo Arthritis (OA). The investigator anticipates that inclusion can be accomplished within a 1 year period and that the total study duration is 3 years. Main study parameters/endpoints are:

• Migration, measured by means of RSA.
• Patient Reported Outcome Measures by means of questionnaires.

Conditions

Osteoarthritis Arthritis; Joint Disease; Musculoskeletal Disease

Keywords

Comparative study; Knee Prosthesis; Prosthesis Design; Treatment Outcome; Follow-up studies; Arthroplast, Replacement, Knee/methods

Outcome Measures

Primary Outcomes (1)

• Migration, measured by means of RSA

  Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA).

  2 Years

Secondary Outcomes (4)

• EQ-5D

  2 Years

• KOOS

  2 Years

• VAS pain

  2 Years

• 2 Anchor questions

  2 Years

Study Arms (2)

ATTUNE

EXPERIMENTAL

Total Knee Replacement Surgery with cementless ATTUNE Rotating Platform Knee Prosthesis by DePuy

Device: ATTUNE Knee Prosthesis by DePuy; Device: LCS Knee Prosthesis by DePuy

LCS

ACTIVE COMPARATOR

Total Knee Replacement Surgery with cementless LCS Rotating Platform Knee Prosthesis by DePuy

Device: ATTUNE Knee Prosthesis by DePuy; Device: LCS Knee Prosthesis by DePuy

Interventions

ATTUNE Knee Prosthesis by DePuy DEVICE

Total Knee Replacement (TKR) Surgery with cementless ATTUNE rotating platform Knee Prosthesis by DePuy

ATTUNE; LCS

LCS Knee Prosthesis by DePuy DEVICE

Total Knee Replacement Surgery with cementless LCS rotating platform Knee Prosthesis by DePuy

ATTUNE; LCS

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is diagnosed with osteoarthritis and requiring primary knee arthroplasty
• All consecutive patients ("usual care") are included to prevent selection bias in the migration analysis.
• Patient is capable of giving informed consent and expressing a willingness to comply with this study

You may not qualify if:

• The patient has an a-priori risk for a posterior-stabilized total knee arthroplasty.
• Status after patellectomy
• In case flexion is less than 90 degrees
• The patient is unable or unwilling to sign the Informed Consent specific to this study
• The patient does not understand the Dutch or English language good enough to participate
• Patients indicated for revision arthroplasty
• Patient is diagnosed with rheumatoid arthritis

Sponsors & Collaborators

• Spaarne Gasthuis: lead
• Leiden University Medical Center: collaborator

Study Sites (2)

Spaarne Gasthuis

Hoofddorp, 2130AT, Netherlands

Location

Leiden University Medical Center

Leiden, 2300RC, Netherlands

Location

MeSH Terms

Conditions

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Rob G Nelissen, Prof PhD MD

  Dep. Orthopaedics, Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

• Peter A Nolte, PhD MD

  Dep. Orthopaedics, Spaarne Gasthuis

  PRINCIPAL INVESTIGATOR

• Edward R Valstar, Prof PhD Msc

  Dep. Orthopaedics, Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 4, 2017
• Study Start: July 25, 2017
• Primary Completion: June 5, 2021
• Study Completion: June 5, 2021
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)