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

NCT ID: NCT02196792

Last Updated: 2022-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-01

Study Completion Date

2030-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis, Hip Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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E-Poly/32 mm

E-Poly polyethylene liner in a titanium cup with a stem with 32 mm cobalt-chromium (CoCr) femoral head.

Group Type ACTIVE_COMPARATOR

E-Poly liner

Intervention Type DEVICE

E-Poly liner with a titanium cup

32 mm femoral head

Intervention Type DEVICE

Stem with a 32 mm CoCr femoral head

E-Poly/36 mm

E-Poly polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.

Group Type ACTIVE_COMPARATOR

E-Poly liner

Intervention Type DEVICE

E-Poly liner with a titanium cup

36 mm femoral head

Intervention Type DEVICE

Stem with a 36 mm CoCr femoral head

ArComXL/32 mm

ArComXL polyethylene liner in a titanium cup with a stem with 32 mm CoCr femoral head.

Group Type ACTIVE_COMPARATOR

ArComXL liner

Intervention Type DEVICE

ArComXL liner with a titanium cup

32 mm femoral head

Intervention Type DEVICE

Stem with a 32 mm CoCr femoral head

ArComXL/36 mm

ArComXL polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.

Group Type ACTIVE_COMPARATOR

ArComXL liner

Intervention Type DEVICE

ArComXL liner with a titanium cup

36 mm femoral head

Intervention Type DEVICE

Stem with a 36 mm CoCr femoral head

Interventions

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E-Poly liner

E-Poly liner with a titanium cup

Intervention Type DEVICE

ArComXL liner

ArComXL liner with a titanium cup

Intervention Type DEVICE

32 mm femoral head

Stem with a 32 mm CoCr femoral head

Intervention Type DEVICE

36 mm femoral head

Stem with a 36 mm CoCr femoral head

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Primary idiopathic arthritis,
* Eligible for uncemented total hip arthroplasty
* 40 to70 years of age,
* Cup size of 54mm and above

Exclusion Criteria

* Anteversion where non-standard stem can be used,
* Dysplasia (Center-edge angle of Wiberg \< 20°),
* Malignant condition
* Prior radiotherapy
* Physical or psychological condition that renders it impossible for the patient to take part in our usual rehabilitation programme (as stated in the department's standard operation procedure),
* Complications during surgery (requiring screws in shell or femoral cerclage)
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joseph Abdalla Nommesen El-Sahoury

Research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph Abdalla N. El-Sahoury, BSc.med

Role: PRINCIPAL_INVESTIGATOR

OUH Den Ortopædkirurgiske Forskningsenhed

Ming Ding, Professor MD

Role: STUDY_DIRECTOR

Odense University Hospital, University of Southern Denmark

Locations

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Joseph Abdalla Nommesen El-Sahoury

Odense C, Region Syddanmark, Denmark

Site Status

Countries

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Denmark

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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project-ID S-20080151

Identifier Type: -

Identifier Source: org_study_id

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