Link LCU + Lima Delta TT vs DePuy Corail + Pinnacle. A Comparative Study of Stem and Cup Fixation and Polyethylene Wear
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Umeå University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Wear
Study Overview
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. Primary outcome are component migration measured by RSA, wear and patient reported outcome. Patients are evaluated up to 15 years postoperatively.
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. The enrolment process will involve a review of the patient history from the medical records in order to match available patient details with the inclusion/exclusion criteria (see below). Patients considered suitable for potential study enrolment will be contacted by a member of the research team to ascertain their level of interest in participating in this study.
Once verbal and written informed consent is provided a medical profile will be taken.
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Stem components
Randomization between two stem components. LCU or Corail stem.
Intervention: Randomization between prosthetic components (Device)
Cup components
Randomization between two cup components. DeltaTT or Pinnacle cup.
Intervention: Randomization between prosthetic components (Device)
Outcomes
Primary Outcomes
Wear
Time Frame: 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.
Femoral stem migration
Time Frame: 1-15 years
Migration measured in millimetres per year with radiostereometric (RSA) analysis of radiographs.
Cup Migration
Time Frame: 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.
Secondary Outcomes
- Short Form Health Survey(1-15 years)
- Patient reported outcome measurement(1-15 years)
- Movement between liner and acetabular components(1-15 years)
- Harris Hip Score(1-15 years)
- EQ5D(1-15 years)
- University of California, Los Angeles (UCLA) activity scale(1-15 years)
- Visual Analog Scale(1-15 years)