RATE AND DISTRIBUTION OF WEAR OF EXPLANTED POLYETHYLENE INSERTS

NCT05482438 | Unknown FDA Device

• 1 other identifier: PEwearStudy
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to measure and compare the wear rates of retrieved PEI after failed TKA with respect to various causes for revision surgery, implant size, surgical and patient factors as well as to identify a characteristic linear wear distribution pattern of the articular surface in most common causes of TKA failure. Consequently, we want to contribute to a better understanding of wear mechanisms and identify a possible additional factor for increased PEI wear in TKA.

Conditions

Evaluation of Polyethylene Wear After Failed TKA

Outcome Measures

Primary Outcomes (2)

• Linear wear

  The linear wear rate will be calculated by dividing the wear by the component time in situ (time from primary TKA to revision operation) and given as mm/year.

  6 months

• Volumetric wear

  The volumetric wear rate will be calculated by dividing the wear by the component time in situ (time from primary TKA to revision operation) and given as mm3 /year.

  6 months

Interventions

Polyethylene DEVICE

Wear measurement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sigma® Cruciate-Retaining Curved GVF i2 from DePuy Synthes (Johnson \& Johnson, Warsaw, IN 46582, USA) PEIs, that were removed during the revision operation between 1.1.2013 (start of Institutional storage of removed knee endoprosthesis components) and 31.12.2021. The listed Sigma® PEI represents the largest share of inserted PEV in primary total knee arthroplasty in Valdoltra Orthopedic Hospital (VOH) in the last decade (from 1.1.2012 to 31.12.2021) and the highest number of single types retrieved PEIs in this period and represents the only reason why we selected this particular implant

You may qualify if:

• primary TKA performed in Valdoltra Orthopedic Hospital (VOH), cement TKA, tibial component Sigma® Modular CoCr Tibia Tray Component (Non-Porous); tibial PEI Sigma® Cruciate-Retaining Curved GVF i2; femoral component Sigma® CR Femoral Component (Non-Porous); revision operation with PE insert removal performed in VOH and PE insert storage.

You may not qualify if:

• endoprosthesis fracture, missing patient, prosthesis type or course of primary and revision surgery data.

Sponsors & Collaborators

• Valdoltra Orthopedic Hospital: lead

Study Sites (1)

Valdoltra Orthopeadic Hospital

Ankaran, 6280, Slovenia

Location

Related Publications (3)

• Pourzal R, Cip J, Rad E, Laurent MP, Berger RA, Jacobs JJ, Wimmer MA. Joint line elevation and tibial slope are associated with increased polyethylene wear in cruciate-retaining total knee replacement. J Orthop Res. 2020 Jul;38(7):1596-1606. doi: 10.1002/jor.24710. Epub 2020 May 25.

  PMID: 32374428 BACKGROUND

• Currier JH, Currier BH, Abdel MP, Berry DJ, Titus AJ, Van Citters DW. What factors drive polyethylene wear in total knee arthroplasty? : results of a large retrieval series. Bone Joint J. 2021 Nov;103-B(11):1695-1701. doi: 10.1302/0301-620X.103B11.BJJ-2020-2334.R1.

  PMID: 34719265 BACKGROUND

• Knowlton CB, Bhutani P, Wimmer MA. Relationship of surface damage appearance and volumetric wear in retrieved TKR polyethylene liners. J Biomed Mater Res B Appl Biomater. 2017 Oct;105(7):2053-2059. doi: 10.1002/jbm.b.33684. Epub 2016 Jul 12.

  PMID: 27401236 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: February 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)