Ceramic-on-Ceramic Total Hip Arthroplasty and Squeaking: Influence of Component Design
This study is currently recruiting participants.
Verified February 2013 by Vejle Hospital
Sponsor:
Vejle Hospital
Information provided by (Responsible Party):
Claus Varnum, Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01420900
First received: August 19, 2011
Last updated: February 3, 2013
Last verified: February 2013
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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 Blind (Subject) 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 Vejle Hospital:
Primary Outcome Measures:
- All noises from THA [ Time Frame: One year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Life quality [ Time Frame: One year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 204 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2013 (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| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420900
Contacts
| Contact: Claus Varnum, MD | claus.varnum@slb.regionsyddanmark.dk |
Locations
| Denmark | |
| Department of Orthopedic Surgery, Vejle Hospital | Recruiting |
| Vejle, Denmark | |
| Contact: Claus Varnum, MD claus.varnum@slb.regionsyddanmark.dk | |
| Principal Investigator: Claus Varnum, MD | |
Sponsors and Collaborators
Vejle Hospital
More Information
No publications provided
| Responsible Party: | Claus Varnum, MD, Vejle Hospital |
| ClinicalTrials.gov Identifier: | NCT01420900 History of Changes |
| Other Study ID Numbers: | man2if |
| Study First Received: | August 19, 2011 |
| Last Updated: | February 3, 2013 |
| Health Authority: | Denmark: National Board of Health |
Additional relevant MeSH terms:
|
Joint Diseases Osteoarthritis Osteoarthritis, Hip |
Musculoskeletal Diseases Arthritis Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013