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Ceramic-on-Ceramic Total Hip Arthroplasty and Squeaking: Influence of Component Design

NCT ID: NCT01420900

Last Updated: 2017-11-07

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

COMPLETED

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2017-11-03

Brief Summary

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The investigators want to examine if specific acetabular liner designs can be a contributing factor to audible squeaking associated with CoC bearings. The aim of the present study is to compare two different designed and well documented acetabular component systems with reference to squeaking and other noises from the hip.

Detailed Description

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Conditions

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Hip Arthrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ABG II / Trident

Group Type ACTIVE_COMPARATOR

THA with ABG II / Trident

Intervention Type DEVICE

Surgery with total hip arthroplasty in the form of ABG II / Trident

CLS / Trilogy

Group Type ACTIVE_COMPARATOR

THA with CLS / Trilogy

Intervention Type DEVICE

Surgery with total hip arthroplasty in the form of CLS / Trilogy

Interventions

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THA with ABG II / Trident

Surgery with total hip arthroplasty in the form of ABG II / Trident

Intervention Type DEVICE

THA with CLS / Trilogy

Surgery with total hip arthroplasty in the form of CLS / Trilogy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients scheduled for uncemented THA under the age of 65 years.

Exclusion Criteria

* Patients with the following diagnoses of the hip: Recent femoral fracture, sequelae from older femoral fracture, acetabular fracture, and traumatic dislocation of the hip.
* Patients without ability to give informed consent and/or willingness to participate in the follow-up protocol.
* Severely impaired level of function due to other physical deficiencies than the hip.
* Mental disability that could impair a patient's decision-making capability of giving informed consent and not enabling valid data collection.
* Earlier primary THA or revision THA in the contralateral hip.
* Pathology requiring another prosthesis concept than the below mentioned.
* Body mass index greater than 35.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vejle Hospital

OTHER

Sponsor Role lead

Responsible Party

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Claus Varnum

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Orthopedic Surgery, Vejle Hospital

Vejle, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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man2if

Identifier Type: -

Identifier Source: org_study_id