NCT01484002

Brief Summary

This retrospective study will investigate the changes that occur in ultrahigh molecular weight polyethylene (UHMWPE) implants that have been retrieved from joint replacement patients. Analysis techniques will include Fourier Transform Infrared Spectroscopy (FTIR), Differential Scanning Calorimeter (DSC) and crosslink density measurements. Crosslink density measurements will be evaluated as a function of distance away from the articular surface and the rim of the implant. Gel and hydroperoxide contents will also be evaluated. The objective is to characterize the in vivo and ex vivo changes that occur with cross-linked and conventional polyethylene bearings sterilized by methods that do not involve radiation. The investigators hypothesize that polyethylene absorbs lipids in vivo but experiences negligible oxidation or reductions in polymer crosslinking until it is explanted and stored at room temperature with access to ambient air.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2011

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2011

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

6 years

First QC Date

November 28, 2011

Last Update Submit

January 23, 2017

Conditions

Osteoarthritis

Keywords

Hip replacementCrosslinked and conventional polyethyleneOxidationCrosslink densityOutcome

Outcome Measures

Primary Outcomes (1)

  • Oxidation levels

    Polyethylene oxidation levels will be quantified as a function of depth away from the articular and rim surfaces using Fourier Transform Infrared Spectroscopy (FTIR). Pre and post-hexane and nitric oxide (NO) exposed post-hexane thin sections will be analyzed.

    At an average of 5 years in vivo

Secondary Outcomes (8)

  • Absorbed lipids

    At an average of 5 years in vivo

  • Crosslink density

    At an average of 5 years in vivo

  • Differential Scanning Calorimeter (DSC)

    At an average of 5 years in vivo

  • Hydroperoxides

    At an average of 5 years in vivo

  • Vinyl end-groups

    At an average of 5 years in vivo

  • +3 more secondary outcomes

Study Arms (2)

Crosslinked polyethylene liners

Polyethylene liners from joint replacements that were crosslinked and heat treated to eliminate free radicals.

Device: Total hip arthroplasty

Conventional polyethylene liners

Polyethylene liners from joint replacements that manufactured from conventional UHMWPE and terminally sterilized by methods that did not involve gamma-irradiation.

Device: Total hip arthroplasty

Interventions

Total hip arthroplastyDEVICE

Replacement of a patient's native hip with an artificial implant featuring a metal-on-polyethylene articulation

Also known as: DePuy Marathon crosslinked polyethylene, DePuy Enduron conventional polyethylene
Conventional polyethylene linersCrosslinked polyethylene liners

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Crosslinked and conventional polyethylene liners terminally sterilized without gamma-irradiation will be used for this study. Specimens will be selected from the implant retrieval collection maintained by the Anderson Orthopaedic Research Institute.

You may qualify if:

  • Retrieved total hip arthroplasty liners maintained by the Anderson Orthopaedic Research Institute
  • Crosslinked or conventional liners terminally sterilized without gamma-irradiation

You may not qualify if:

  • Liners terminally sterilized with gamma-irradiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Orthopaedic Biomechanics and Biomaterials Laboratory at Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Anderson Orthopaedic Research Institute

Alexandria, Virginia, 22306, United States

Location

Related Publications (6)

  • Muratoglu OK, Wannomae KK, Rowell SL, Micheli BR, Malchau H. Ex vivo stability loss of irradiated and melted ultra-high molecular weight polyethylene. J Bone Joint Surg Am. 2010 Dec 1;92(17):2809-16. doi: 10.2106/JBJS.I.01017.

    PMID: 21123611BACKGROUND

  • Bargmann LS, Bargmann BC, Collier JP, Currier BH, Mayor MB. Current sterilization and packaging methods for polyethylene. Clin Orthop Relat Res. 1999 Dec;(369):49-58. doi: 10.1097/00003086-199912000-00006.

    PMID: 10611860BACKGROUND

  • Currier BH, Van Citters DW, Currier JH, Collier JP. In vivo oxidation in remelted highly cross-linked retrievals. J Bone Joint Surg Am. 2010 Oct 20;92(14):2409-18. doi: 10.2106/JBJS.I.01006.

    PMID: 20962191BACKGROUND

  • Currier BH, Currier JH, Mayor MB, Lyford KA, Collier JP, Van Citters DW. Evaluation of oxidation and fatigue damage of retrieved crossfire polyethylene acetabular cups. J Bone Joint Surg Am. 2007 Sep;89(9):2023-9. doi: 10.2106/JBJS.F.00336.

    PMID: 17768201BACKGROUND

  • Engh CA Jr, Stepniewski AS, Ginn SD, Beykirch SE, Sychterz-Terefenko CJ, Hopper RH Jr, Engh CA. A randomized prospective evaluation of outcomes after total hip arthroplasty using cross-linked marathon and non-cross-linked Enduron polyethylene liners. J Arthroplasty. 2006 Sep;21(6 Suppl 2):17-25. doi: 10.1016/j.arth.2006.05.002.

    PMID: 16950057BACKGROUND

  • Malchau H, Bragdon CR, Muratoglu OK. The stepwise introduction of innovation into orthopedic surgery: the next level of dilemmas. J Arthroplasty. 2011 Sep;26(6):825-31. doi: 10.1016/j.arth.2010.08.007. Epub 2010 Oct 2.

    PMID: 20888183BACKGROUND

Related Links

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Robert H Hopper, Jr., PhD

    Anderson Orthopaedic Research Institute

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 28, 2011

First Posted

December 2, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

US(2)