Back to resultsCeramic-on-Ceramic Total Hip Arthroplasty and Squeaking: Influence of Component Design
Primary Purpose
Hip Arthrosis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
THA with ABG II / Trident
THA with CLS / Trilogy
Sponsored by
About this trial
This is an interventional treatment trial for Hip Arthrosis
Eligibility 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.
Sites / Locations
- Department of Orthopedic Surgery, Vejle Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ABG II / Trident
CLS / Trilogy
Arm Description
Outcomes
Primary Outcome Measures
All noises from THA
Secondary Outcome Measures
Life quality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01420900
Brief Title
Ceramic-on-Ceramic Total Hip Arthroplasty and Squeaking: Influence of Component Design
Official Title
Ceramic-on-Ceramic Total Hip Arthroplasty and Squeaking: A Prospective, Blinded, Randomized Clinical Trial of Influence of Component Design
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 3, 2017 (Actual)
Study Completion Date
November 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vejle Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
204 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABG II / Trident
Arm Type
Active Comparator
Arm Title
CLS / Trilogy
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
THA with ABG II / Trident
Intervention Description
Surgery with total hip arthroplasty in the form of ABG II / Trident
Intervention Type
Device
Intervention Name(s)
THA with CLS / Trilogy
Intervention Description
Surgery with total hip arthroplasty in the form of CLS / Trilogy
Primary Outcome Measure Information:
Title
All noises from THA
Time Frame
One year
Secondary Outcome Measure Information:
Title
Life quality
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Department of Orthopedic Surgery, Vejle Hospital
City
Vejle
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Ceramic-on-Ceramic Total Hip Arthroplasty and Squeaking: Influence of Component Design
We'll reach out to this number within 24 hrs