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

NCT05623215 | Active Not Recruiting FDA Device

• 1 other identifier: NL82000.058.22
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty; Total Knee Replacement; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Inducible displacement

  5 years post TKA

• Inducible displacement

  10 years post TKA

• EuroQol 5D-5L (EQ-5D-5L)

  5 year post TKA

• EuroQol 5D-5L (EQ-5D-5L)

  10 year post TKA

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

  5 year post TKA

Other Outcomes (2)

• Complications

  5 year post TKA

• Complications

  10 year post TKA

Study Arms (2)

Cementless ATTUNE

Cementless ATTUNE Rotating Platform Cruciate Sacrificing Knee System

Radiation: Radiographs of the knee for radiostereometric analysis (RSA)

Cementless LCS

Cementless LCS rotating platform Cruciate Sacrificing Knee System

Radiation: Radiographs of the knee for radiostereometric analysis (RSA)

Interventions

Radiographs of the knee for radiostereometric analysis (RSA) RADIATION

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

Cementless ATTUNE; Cementless LCS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Spaarne Gasthuis

Hoofddorp, North Holland, 2134TM, Netherlands

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Peter A. Nolte, Prof. MD

  Spaarne Gasthuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: drs

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 21, 2022
• Study Start: November 10, 2022
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)