Status:
TERMINATED
A Multicentre Trial to Compare Two Articulating Bearing Surfaces as Used in Cementless Primary Hip Arthroplasty
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The aim of this study is to demonstrate the non-inferiority of the ceramic-on-metal articulation using large diameter bearings (38mm to 60mm) compared to the metal on metal articulation using the same...
Detailed Description
This multicentre randomised controlled trial will compare the clinical outcome of the ceramic-on-metal articulation against a metal-on-metal articulation using the same Recap Acetabular cup. The meta...
Eligibility Criteria
Inclusion
- Primary total hip replacement
- Patient with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of osteoarthritis,avascular necrosis, legg perthes, rheumatoid arthritis, diastrophic variant, fracture of the pelvis, fused hip, slipped capital epiphysis, subcapital fractures, traumatic arthritis
- Patients preoperative Harris hip score \< 80 points
- Patients with limited co-morbidity - ASA I - III
- Patients with normal urea and electrolyte levels and creatinine levels
- Patients must be able to understand instructions and be willing to return for follow-up
- Patients willing to provide blood and urine samples for metal ion analysis at follow-up
Exclusion
- Patient preoperative Harris hip score \> 80 points
- Pre-existing metal implants
- Patients with significant co-morbidity - ASSA IV - V
- Dementia and inability to understand and follow instructions
- Neurological conditions affecting movement
- Women younger than 45 years old
- Presence of symptomatic arthritis in other lower limb joints
- Patients requiring smaller than 38mm and larger than 60mm diameter femoral heads
- Patients taking NSAIDs and / all drugs that will affect bone metabolism
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2015
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01247038
Start Date
January 1 2011
End Date
July 10 2015
Last Update
June 21 2017
Active Locations (2)
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1
Orthopaedic Hospital & Rehabilitation Clinic of "Dr Miroslav Zotovic"
Banja Luka, Bosnia and Herzegovina
2
Johannesburg Hospital
Parktown, South Africa