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Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement

NCT02196792 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-06-21

No results posted yet for this study

Summary

The objective of the study is to investigate head penetration, cup migration, and clinical outcome in total hip replacements using a factorial design. Treatment groups are E-Poly versus ArComXL liners, and 36 mm versus 32 mm head size.

Conditions

Interventions

DEVICE

E-Poly liner

E-Poly liner with a titanium cup

DEVICE

ArComXL liner

ArComXL liner with a titanium cup

DEVICE

32 mm femoral head

Stem with a 32 mm CoCr femoral head

DEVICE

36 mm femoral head

Stem with a 36 mm CoCr femoral head

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Joseph Abdalla N. El-Sahoury, BSc.med · OUH Den Ortopædkirurgiske Forskningsenhed

  • Ming Ding, Professor MD · Odense University Hospital, University of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-01
Primary Completion
2015-05-01
Completion
2030-05-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

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 NCT02196792 on ClinicalTrials.gov