ALknee Follow-up Study of the Cementless ATTUNE Rotating Platform and the Cementless LCS Rotating Platform Knee System

Comparing the Migration and Inducible Displacement Through RSA of the Cementless ATTUNE Rotating Platform and the Cementless LCS Rotating Platform Knee System; A Clinical Randomized Controlled RSA Follow-up Study

The cementless ATTUNETM Rotating Platform Knee system was compared in a single-blind, randomized RSA trial to its predecessor, the LCS rotating platform Knee System. In this previous study, 61 knees were subjected to RSA examinations at 1-day and 3, 6, 12 and 24 months postoperative. This study found a promising equal migration of both tibial components and a lesser migration of the femoral component of the ATTUNETM knee system after two years, although with a similar migration rate between year 1 and 2. this raises the question of whether the migration of the prostheses relative to each other will increase or remain the same in the long term. To examine this, a mid-and long-term RSA follow-up to measure migration is necessary. In addition, another new RSA measurement parameter has become known in recent years that may provide an indication of the bonding of the prosthesis to the bone at the time of measurement. This new parameter, called the Induced Displacement (ID) of a prosthesis, measures the position and orientation relative to the bone while the prosthesis is under different loading conditions (e.g., patient in supine or standing position). This means that a large measured difference between these different loading condition measurements would indicate that osseointegration of the prosthesis never occurred or is no longer present. To improve the understanding of the tendency of both prostheses to aseptic loosening after a mid- to long-term follow up, migration over time and inducible displacement analyses are necessary.

The primary objective of this study is to accurately compare mid- and long-term migration of two uncemented TKR prostheses. The secondary objectives of this study are to evaluate if inducible displacement can be used as a parameter to detect loose implants, and to compare inducible displacement, clinical and radiological outcome and patient-reported outcomes (PROMS) after a follow-up of 5 and 10 years of two uncemented TKR prostheses.

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Osteoarthritis; Total Knee Arthroplasty; Total Knee Replacement
• Intervention / Treatment: Radiation: Radiographs of the knee for radiostereometric analysis (RSA)

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Hoofddorp, Noord-Holland, Netherlands, 2134TM
      • Spaarne Gasthuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

In this study, all subjects that participated in the initial study (ALknee study - NL58911.058.16) will be asked to participate. All these patients underwent a TKA for symptomatic osteoarthritis of the knee in the period of August 2017 and March 2018 at the Department of Orthopaedics in the Spaarne Gasthuis, Hoofddorp, The Netherlands.

Description

Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

• The Patient participated in the initial study (NL58911.058.16) [1].
• The patient is capable of giving informed consent and expressing a willingness to comply with the study.

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

• The patient underwent a major revision TKR (exchange of the tibial or femoral component).
• The patient is unable or unwilling to sign the informed consent specific to this study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cementless ATTUNE; Cementless ATTUNE Rotating Platform Cruciate Sacrificing Knee System	Radiation: Radiographs of the knee for radiostereometric analysis (RSA); RSA radiographs will be made 5 and 10 years after the total knee arthroplasty.
Cementless LCS; Cementless LCS rotating platform Cruciate Sacrificing Knee System	Radiation: Radiographs of the knee for radiostereometric analysis (RSA); RSA radiographs will be made 5 and 10 years after the total knee arthroplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline migration of the prostheses	Migration is measured and expressed in translations, rotations, and MTPM; MTPM is the point of the prosthesis that has moved most.	5 years post TKA
Ten year change from baseline migration of the prostheses	Migration is measured and expressed in translations, rotations and MTPM; MTPM is the point of the prosthesis that has moved most.	10 years post TKA

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inducible displacement	The inducible displacement is defined as the difference in translation (MTPM) between a measurement without external force (e.g., supine position) and a measurement with external force (e.g., weight bearing) minus the measurement error.	5 years post TKA
Inducible displacement	The inducible displacement is defined as the difference in translation (MTPM) between a measurement without external force (e.g., supine position) and a measurement with external force (e.g., weight bearing) minus the measurement error.	10 years post TKA
EuroQol 5D-5L (EQ-5D-5L)	A patient reported outcome score for assessing mental well-being by using a score from 0 to 1, with 0 = worse and 1 = best.	5 year post TKA
EuroQol 5D-5L (EQ-5D-5L)	A patient reported outcome score for assessing mental well-being by using a score from 0 to 1, with 0 = worse and 1 = best.	10 year post TKA
Knee injury and Osteoarthritis Outcome Scale Physical Function Short-form (KOOS-PS)	A 7-item patient reported outcome score that measures daily physical functioning by using a score of 0 to 100, with 0 = no problems and 100 = extreme problems.	5 year post TKA
Knee injury and Osteoarthritis Outcome Scale Physical Function Short-form (KOOS-PS)	A 7-item patient reported outcome score that measures daily physical functioning by using a score of 0 to 100, with 0 = no problems and 100 = extreme problems.	10 year post TKA
Oxford-12 Knee Score (OKS)	A 12-item patient-reported outcome score to assess function and pain after total knee arthroplasty. The score uses a score of 0 to 48, with 0 = worse and 48 = best.	5 year post TKA
Oxford-12 Knee Score (OKS)	A 12-item patient-reported outcome score to assess function and pain after total knee arthroplasty. The score uses a score of 0 to 48, with 0 = worse and 48 = best.	10 year post TKA
Kujala Anterior Knee Pain Scale (AKPS)	A 13-item patient reported outcome score for assessing daily anterior knee pain, by using a score from 0 to 100, with 0 = having anterior knee pain with disabilities and 100 = no signs of anterior knee pain.	5 year post TKA
Kujala Anterior Knee Pain Scale (AKPS)	A 13-item patient reported outcome score for assessing daily anterior knee pain, by using a score from 0 to 100, with 0 = having anterior knee pain with disabilities and 100 = no signs of anterior knee pain.	10 year post TKA
Numeric Rating Scale (NRS)	A patient reported outcome score for assessing pain by using a likert scale from 0 to 10, with 0 = no pain and 10 = severe pain)	5 year post TKA
Numeric Rating Scale (NRS)	A patient reported outcome score for assessing pain by using a likert scale from 0 to 10, with 0 = no pain and 10 = severe pain)	10 year post TKA
Anchor questions	A patient reported outcome score for assessing change in functioning and pain since surgery. The outcome is evaluated by use of a likert scale from 1 to 7, with 1 = much deteriorated and 7 = much improved).	5 year post TKA
Anchor questions	A patient reported outcome score for assessing change in functioning and pain since surgery. The outcome is evaluated by use of a likert scale from 1 to 7, with 1 = much deteriorated and 7 = much improved).	10 year post TKA

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Complications during follow-up will be reported	5 year post TKA
Complications	Complications during follow-up will be reported	10 year post TKA

Collaborators and Investigators

• Sponsor: Spaarne Gasthuis
• Collaborators: Leiden University Medical Center
• Investigators: Principal Investigator: Peter A. Nolte, Prof. MD, Spaarne Gasthuis

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: NL82000.058.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No