Hip Osteoarthritis
Conditions
Keywords
navigation, hip arthroplasty, surgical time, landmark
Brief summary
A prospective randomized study comparing accuracy and precision of acetabular component placement in total hip arthroplasty with use of novel electromagnetic navigation system versus freehand technique.
Detailed description
Patients with hip arthritis, who are to be treated with total hip arthroplasty will be randomized in two groups. Patents allocated to study group will get their acetabular components implanted with the help of electromagnetic navigation system. Patients allocated to the control group will get their acetabular components implanted with freehand technique. Accuracy and precision of implanted acetabular components will be assessed on images obtained by postoperative computed tomography. Postoperative inclination and anteversion angles of acetabular components will be measured by the independent technician. Results will be statistically analyzed and compared.
Interventions
PROCEDUREElectromagnetic navigation
Acetabular component placement in total hip arthroplasty will be performed wit the help of electromagnetic image-less navigation system.
PROCEDUREFreehand
In the control group acetabular components in total hip arthroplasty will be placed with the help of the freehand technique.
Sponsors
Valdoltra Orthopedic Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Postoperative computed tomography measurements of acetabular component position will be done by independent technician.
Intervention model description
Sample size will be calculated. The Consolidated Standards of Reporting Trials statement guidelines will be followed to perform this prospective, randomized, controlled, trial and to present the results. Included patients will be randomly allocated in a 1:1 ratio into the study and the control group. Randomization will be conducted using computer-generated numbers.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age above 18 years * unilateral surgery * osteoarthritis of the hip * no previous surgery on the affected hip * implantation of the same acetabular component through the same approach * signed informed consent
Exclusion criteria
* age under 18 years * unwilling to participate * prior surgery on affected hip
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acetabular component position | Up to 48 hours after surgery | Comparison of the precision and the accuracy of acetabular components between both groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical time | Immediately after surgical procedure | Comparison of duration of surgery between both groups |
| Clinical result | 8-10 weeks postoperatively | Comparison of improvement of Harris hip score between both groups |
Countries
Slovenia
Outcome results
None listed