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Completed

NCT Number: NCT01420900

Ceramic-on-Ceramic Total Hip Arthroplasty and Squeaking: 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.

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Key information

Conditions

Hip Arthrosis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopedic Surgery, Vejle Hospital

Vejle, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

THA with ABG II / Trident

Device

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

THA with CLS / Trilogy

Device

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

Primary outcomes

  1. All noises from THA

    Time frame: One year

Secondary outcomes

  1. Life quality

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Aug 22, 2011
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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