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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electromagnetic navigation | Experimental | In the study group acetabular components in total hip arthroplasty will be placed with the help of electromagnetic image-less navigation system. Reference plane will be anterior pelvic plane. |
|
| Freehand | Active Comparator | In the control group acetabular components in total hip arthroplasty will be placed with the help of the freehand technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electromagnetic navigation | Procedure | Acetabular component placement in total hip arthroplasty will be performed wit the help of electromagnetic image-less navigation system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acetabular component position | Comparison of the precision and the accuracy of acetabular components between both groups | Up to 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical time | Comparison of duration of surgery between both groups | Immediately after surgical procedure |
| Clinical result | Comparison of improvement of Harris hip score between both groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rene Mihalič, MD | Valdoltra Orthopedic Hospital | Principal Investigator |
| Rihard Trebše, MD, PhD | Valdoltra Orthopedic Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valdoltra Orthopedic Hospital | Ankaran | 6280 | Slovenia |
No data will be shared with other researchers.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 29, 2022 | |
| Reset | Jan 27, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 29, 2022 | Jan 27, 2023 |
| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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.
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Postoperative computed tomography measurements of acetabular component position will be done by independent technician.
| Freehand | Procedure | In the control group acetabular components in total hip arthroplasty will be placed with the help of the freehand technique. |
|
| 8-10 weeks postoperatively |
| D012216 |
| Rheumatic Diseases |