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This study was initiated to investigate the impact of the computer based image free navigation on the precision of the cup implantation. The implantation of the acetabular component (cup) is known to be a critical step in hip endoprosthetics. The cup position influences significantly the function, the absence of pain and the longevity of the artificial hip joint. The image free navigation system OrthoPilot is used to control the positioning of the cup during surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual | Sham Comparator | Manual Implantation of THA |
|
| Navigated | Experimental | Navigated Implantation of THA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Intervention | Procedure | Implantation of acetabular component without the use of the navigation system information |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of improvement of the implantation accuracy of acetabular component by navigation compared to manual implantation | The ratio of implantations within the intraoperatively adjusted safe zone of Lewinnek (target anteversion +/-10°, target inclination +/-10°), proved by a CT-scan control measurement. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of implantation precision, postoperative function and complication rates with vs. without gaining information from navigation system. | The ratio of implantations within the intraoperatively determined safe zone of 5° (target anteversion +/-5°, target inclination +/- 5°) Geometric deviation from the target implantation position Range of Motion Harris hip score 3 months postoperative Complication rate until 3 months Correlation of manual and ultrasound registration of the anterior pelvic plane (independent from therapy group) Proposal and validation of a combined Hip Alignment Score for navigated implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hartmuth Kiefer, Prof. Dr. | Lukas Krankenhaus Bünde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lukas-Krankenhaus | Bünde | 32257 | Germany |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D001172 | Arthritis, Rheumatoid |
| D005271 | Femur Head Necrosis |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Navigated Intervention | Procedure | Navigated implantation of acetabular component using OrthoPilot image free navigation system |
|
|
| 3 months |
| D012216 |
| Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010020 | Osteonecrosis |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |