Randomization between prosthetic components: Patients are randomized between two types of stem components and two types of cup components in total hip arthroplasty. Thus randomized between 4 different groups.
Study 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. Primary outcome are component migration measured by RSA, wear and patient reported outcome. Patients are evaluated up to 15 years postoperatively.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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
Primary outcome measure(s)
Cup Migration — 1-15 years Migration measured in millimetres per year with radiostereometric (RSA) analysis of radiographs. Radiostereometric analysis (RSA) is a stereo X-ray technique used in clinical research studies to evaluate micro-motion and wear of orthopaedic implants within bone. The method has a high accuracy and precision. Technical requirements include the need for implanted marker beads and radiograph view angles determined by a calibration cage.
Femoral stem migration — 1-15 years Migration measured in millimetres per year with radiostereometric (RSA) analysis of radiographs.
Wear — 1-15 years The size of the femoral component penetration into the polyethylene measured in millimeters per year and the volumetric annual wear millimetres with radiostereometric (RSA) analysis of radiographs.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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