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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01420900
First Posted: August 22, 2011
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Claus Varnum, Vejle Hospital
  Purpose
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.

Condition Intervention
Hip Arthrosis Device: THA with ABG II / Trident Device: THA with CLS / Trilogy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Ceramic-on-Ceramic Total Hip Arthroplasty and Squeaking: A Prospective, Blinded, Randomized Clinical Trial of Influence of Component Design

Resource links provided by NLM:


Further study details as provided by Claus Varnum, Vejle Hospital:

Primary Outcome Measures:
  • All noises from THA [ Time Frame: One year ]

Secondary Outcome Measures:
  • Life quality [ Time Frame: One year ]

Enrollment: 204
Study Start Date: September 2011
Study Completion Date: November 3, 2017
Primary Completion Date: November 3, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420900


Locations
Denmark
Department of Orthopedic Surgery, Vejle Hospital
Vejle, Denmark
Sponsors and Collaborators
Vejle Hospital
  More Information

Responsible Party: Claus Varnum, MD, Vejle Hospital
ClinicalTrials.gov Identifier: NCT01420900     History of Changes
Other Study ID Numbers: man2if
First Submitted: August 19, 2011
First Posted: August 22, 2011
Last Update Posted: November 7, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis, Hip
Musculoskeletal Diseases
Osteoarthritis
Arthritis
Rheumatic Diseases