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

Hip Arthrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420900
• Other study ID #: man2if
• Status: Completed
• Phase: N/A
• First received: August 19, 2011
• Last updated: November 3, 2017
• Start date: September 2011
• Est. completion date: November 3, 2017

Study information

• Verified date: November 2017
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: November 3, 2017
• Est. primary completion date: November 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hip Arthrosis
• Joint Diseases
• Osteoarthritis, Hip

Intervention

Device:
• THA with ABG II / Trident
Surgery with total hip arthroplasty in the form of ABG II / Trident
• THA with CLS / Trilogy
Surgery with total hip arthroplasty in the form of CLS / Trilogy

Locations

Country	Name	City	State
Denmark	Department of Orthopedic Surgery, Vejle Hospital	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All noises from THA		One year
Secondary	Life quality		One year