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Completed

NCT Number: NCT03101007

RSA RCT: Attune RP TKA Versus LCS RP TKA

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Disease Joint Diseases Musculoskeletal Disease Musculoskeletal Diseases

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaarne Gasthuis, Hoofddorp, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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
  • When there are not enough markers visible in the baseline RSA photograph and it will not improve by placing the patient in another position, the patient will be excluded from the study (secondary exclusion criteria).

Treatment and study plan

ATTUNE Knee Prosthesis by DePuy

Device

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

LCS Knee Prosthesis by DePuy

Device

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

Primary outcomes

  1. Migration, measured by means of RSA

    Time frame: 2 Years

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

Secondary outcomes

  1. EQ-5D

    Time frame: 2 Years

    General Health: EuroQol 5 Dimensional (EQ-5D) Health Questionnaire measured using patient questionnaire

  2. KOOS

    Time frame: 2 Years

    Knee Function: Knee injury and Osteoarthritis Outcome Score (KOOS) measured using patient questionnaire

  3. VAS pain

    Time frame: 2 Years

    Pain score after activity and during rest; (Likert scale 0-10)

  4. 2 Anchor questions

    Time frame: 2 Years

    Two anchor questions (Likert scale 1-7) about change in functioning and pain since surgery.

Sponsors and collaborators

Lead sponsor

Spaarne Gasthuis

Other

Collaborators

  • Leiden University Medical Center

Registry information

Official study title

A CLINICAL RANDOMIZED CONTROLLED RSA TRIAL COMPARING THE CEMENTLESS ATTUNE ROTATING PLATFORM KNEE SYSTEM TO THE CEMENTLESS LCS ROTATING PLATFORM KNEE SYSTEM

Acronym: ALKNEE

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 4, 2017
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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