Status:
ACTIVE_NOT_RECRUITING
A Comparative Study of Stem and Cup Fixation and Polyethylene Wear
Lead Sponsor:
Umeå University
Conditions:
Osteoarthritis, Hip
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
A randomized controlled study comparing two types of cementless femoral stems (LCU and Corail) and two types of acetabular components (DeltaTT and Pinnacle Duofix) in primary total hip arthroplasty. P...
Detailed Description
Material Patients The study will be conducted according to GCP, (Good Clinical Practice). Potential clinical study participants will be identified from the THR waiting list of Umeå University Hospital...
Eligibility Criteria
Inclusion
- Primary or secondary osteoarthritis of the hip
- Male and non-pregnant female patients aged 18 to 70 years of age
- Type A or B femur
- Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up
Exclusion
- BMI under 18 and over 35
- Inflammatory arthritis
- Osteoporosis
- Paget's disease
- Grossly abnormal hip anatomy (severe dysplasia)
- Previous operations in the same hip
- Presence of malignancy
- Patients who, as judged by the surgeon, are mentally incompetent or are reasonable unlikely to be compliant with the requirements of the study
- Patient is female of child-bearing age and not taking contraceptive precautions
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2033
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04064723
Start Date
January 1 2015
End Date
November 30 2033
Last Update
December 14 2023
Active Locations (1)
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1
Volker TC Otten
Umeå, Västerbotten County, Sweden, 901 89