Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05623215

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Total Knee Arthroplasty Arthritis Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases Total Knee Replacement

Sex eligibility

All sexes

Study type

Observational

Primary location

Spaarne Gasthuis

Hoofddorp, North Holland, 2134TM, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Radiographs of the knee for radiostereometric analysis (RSA)

Radiation

RSA radiographs will be made 5 and 10 years after the total knee arthroplasty.

Primary outcomes

  1. Change from baseline migration of the prostheses

    Time frame: 5 years post TKA

    Migration is measured and expressed in translations, rotations, and MTPM; MTPM is the point of the prosthesis that has moved most.

  2. Ten year change from baseline migration of the prostheses

    Time frame: 10 years post TKA

    Migration is measured and expressed in translations, rotations and MTPM; MTPM is the point of the prosthesis that has moved most.

Secondary outcomes

  1. Inducible displacement

    Time frame: 5 years post TKA

    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.

  2. Inducible displacement

    Time frame: 10 years post TKA

    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.

  3. EuroQol 5D-5L (EQ-5D-5L)

    Time frame: 5 year post TKA

    A patient reported outcome score for assessing mental well-being by using a score from 0 to 1, with 0 = worse and 1 = best.

  4. EuroQol 5D-5L (EQ-5D-5L)

    Time frame: 10 year post TKA

    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. Knee injury and Osteoarthritis Outcome Scale Physical Function Short-form (KOOS-PS)

    Time frame: 5 year post TKA

    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.

  6. Knee injury and Osteoarthritis Outcome Scale Physical Function Short-form (KOOS-PS)

    Time frame: 10 year post TKA

    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.

  7. Oxford-12 Knee Score (OKS)

    Time frame: 5 year post TKA

    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.

  8. Oxford-12 Knee Score (OKS)

    Time frame: 10 year post TKA

    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.

  9. Kujala Anterior Knee Pain Scale (AKPS)

    Time frame: 5 year post TKA

    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. Kujala Anterior Knee Pain Scale (AKPS)

    Time frame: 10 year post TKA

    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.

  11. Numeric Rating Scale (NRS)

    Time frame: 5 year post TKA

    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)

  12. Numeric Rating Scale (NRS)

    Time frame: 10 year post TKA

    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)

  13. Anchor questions

    Time frame: 5 year post TKA

    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).

  14. Anchor questions

    Time frame: 10 year post TKA

    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).

Other outcomes

  1. Complications

    Time frame: 5 year post TKA

    Complications during follow-up will be reported

  2. Complications

    Time frame: 10 year post TKA

    Complications during follow-up will be reported

Sponsors and collaborators

Lead sponsor

Spaarne Gasthuis

Other

Collaborators

  • Leiden University Medical Center

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Nov 21, 2022
Registry last updated
Apr 18, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.