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Vitamin E-Diffused Highly Cross-Linked Polyethylene Liner

NCT02801019 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2016-06-15

No results posted yet for this study

Summary

Vitamin E incorporated highly cross linked polyethylene (E-XLPE) was developed to increase oxidative resistance of highly cross-linked polyethylene (XLPE) without affecting mechanical properties. The investigators evaluated this type of polyethylene in a randomized clinical study, using Radiostereometric Analysis (RSA). The objective of this study was to compare the early-term wear of E-XLPE to a compression annealed polyethylene liner (C-XLPE, ArComXL®). The clinical outcome at two years was not expected to be affected by the choice of polyethylene.

Conditions

Interventions

OTHER

E-poly

comparison of two different polyethylene plastic 0,04 mm at 3 months 0,06 at 2 years

OTHER

ArComXL

comparison of two different polyethylene plastic 0,03 mm at 3 months 0,10 mm at 2 years

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Johan Kärrholm, Professor · Sahlgrenska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-11-30
Completion
2011-11-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02801019 on ClinicalTrials.gov