Clinical trial NCT05623215: ALknee Follow-up Study of the Cementless ATTUNE Rotating Platform and the Cementless LCS Rotating Platform Knee System
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Total Knee Arthroplasty
Total Knee Replacement
Knee Osteoarthritis
Lead sponsor: Spaarne Gasthuis
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
First posted: 2022-11-21
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline migration of the prostheses
timeFrame: 5 years post TKA
measure: Ten year change from baseline migration of the prostheses
timeFrame: 10 years post TKA
Secondary outcomes:
measure: Inducible displacement
timeFrame: 5 years post TKA
measure: Inducible displacement
timeFrame: 10 years post TKA
measure: EuroQol 5D-5L (EQ-5D-5L)
timeFrame: 5 year post TKA
measure: EuroQol 5D-5L (EQ-5D-5L)
timeFrame: 10 year post TKA
measure: Knee injury and Osteoarthritis Outcome Scale Physical Function Short-form (KOOS-PS)
timeFrame: 5 year post TKA
measure: Knee injury and Osteoarthritis Outcome Scale Physical Function Short-form (KOOS-PS)
timeFrame: 10 year post TKA
measure: Oxford-12 Knee Score (OKS)
timeFrame: 5 year post TKA
measure: Oxford-12 Knee Score (OKS)
timeFrame: 10 year post TKA
measure: Kujala Anterior Knee Pain Scale (AKPS)
timeFrame: 5 year post TKA
measure: Kujala Anterior Knee Pain Scale (AKPS)
timeFrame: 10 year post TKA
measure: Numeric Rating Scale (NRS)
timeFrame: 5 year post TKA
measure: Numeric Rating Scale (NRS)
timeFrame: 10 year post TKA
measure: Anchor questions
timeFrame: 5 year post TKA
measure: Anchor questions
timeFrame: 10 year post TKA
Other outcomes:
measure: Complications
timeFrame: 5 year post TKA
measure: Complications
timeFrame: 10 year post TKA
Locations:
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis
state: Noord-Holland
Study officials:
affiliation: Spaarne Gasthuis
name: Peter A. Nolte, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: