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

November 3, 2017 updated by: Claus Varnum, Vejle Hospital

Ceramic-on-Ceramic Total Hip Arthroplasty and Squeaking: A Prospective, Blinded, Randomized Clinical Trial of Influence of Component Design

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Vejle, Denmark
        • Department of Orthopedic Surgery, Vejle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: ABG II / Trident
Device: THA with ABG II / Trident
Surgery with total hip arthroplasty in the form of ABG II / Trident
ACTIVE_COMPARATOR: CLS / Trilogy
Device: THA with CLS / Trilogy
Surgery with total hip arthroplasty in the form of CLS / Trilogy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All noises from THA
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Life quality
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

November 3, 2017

Study Completion (ACTUAL)

November 3, 2017

Study Registration Dates

First Submitted

August 19, 2011

First Submitted That Met QC Criteria

August 19, 2011

First Posted (ESTIMATE)

August 22, 2011

Study Record Updates

Last Update Posted (ACTUAL)

November 7, 2017

Last Update Submitted That Met QC Criteria

November 3, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • man2if

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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