Trial · NCT07904637
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Exact Acetabular Cup Size Prediction Accuracy | During surgery | The percentage of cases in which the planned acetabular cup size exactly matches the actual implanted cup size. Exact matching will be assessed separately for conventional imaging-based planning (Plan A) and 3D-printed-model-assisted planning (Plan B), using the intraoperative implant record as the reference. |
| Primary | Acetabular Cup Size Prediction Accuracy Within 2 mm | During surgery | The percentage of cases in which the planned acetabular cup size is within 2 mm or one implant size of the actual implanted cup size. Accuracy will be calculated separately for Plan A and Plan B and compared using the intraoperative implant record. |
| Primary | Absolute Error in Acetabular Cup Inclination | Immediate postoperative imaging | The absolute difference, measured in degrees, between the planned acetabular cup inclination and the achieved postoperative cup inclination. Errors will be calculated separately for Plan A and Plan B using postoperative radiographic or CT measurements, allowing a paired comparison of planning accuracy. |
| Primary | Absolute Error in Acetabular Cup Anteversion | Immediate postoperative imaging | The absolute difference, measured in degrees, between the planned acetabular cup anteversion and the achieved postoperative cup anteversion. Errors will be calculated separately for Plan A and Plan B using postoperative radiographic or CT measurements, allowing a paired comparison of planning accuracy. |
| Secondary | Changes in Preoperative Surgical Planning | During preoperative planning | Percentage of cases in which Plan B differs from Plan A in planned cup size, target cup orientation, augment or cage requirement, or screw fixation strategy. Each type of planning change will be recorded. |
| Secondary | Agreement of Paprosky Classification With Intraoperative Findin | Preoperative assessment and during surgery SECONDARY OUTCOME | Percentage agreement and Cohen's kappa between Paprosky classifications obtained from conventional imaging (Plan A) and 3D-model-assisted assessment (Plan B), compared with the intraoperative classification recorded by the senior surgeon. |
| Secondary | Restoration of Hip Center and Offset | Preoperative assessment and immediate postoperative imaging | Radiographic assessment of the hip center and hip offset before and after total hip arthroplasty. Measurements will be recorded in millimeters to evaluate postoperative anatomical restoration. |
| Secondary | Agreement Between Planned and Actual Acetabular Reconstruction | During surgery | Agreement between the anticipated need for acetabular augments, buttresses, or cages in Plan A and Plan B and the reconstructive components actually used during surgery. Results will be reported by reconstruction category. |
| Secondary | Operative Time | During surgery | Duration of total hip arthroplasty, measured in minutes and recorded for each surgical case. |
| Secondary | Estimated Intraoperative Blood Loss | During surgery | Estimated volume of blood lost during total hip arthroplasty, measured in milliliters. |
| Secondary | Incidence of Intraoperative Complications | During surgery | Number and percentage of patients experiencing intraoperative complications during total hip arthroplasty, with the type of complication recorded. |
| Secondary | Incidence of Postoperative Complications | From surgery through 6-month postoperative follow-up | Number and percentage of patients experiencing postoperative complications, including dislocation, loosening, fracture, infection, nerve palsy, and thromboembolic events. |
| Secondary | Change in Postoperative Hip Functional Score | Baseline, 6 weeks, 3 months, and 6 months postoperatively | Change from baseline in hip function assessed using the Harris Hip Score and/or Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS-JR), according to the functional instrument selected in the study protocol. |
| Secondary | Surgeon Confidence in Preoperative Planning | Immediately after completion of each preoperative plan | Surgeon-reported confidence in each preoperative plan, measured using a numeric rating scale from 0 to 10. Scores will be recorded separately for Plan A and Plan B. |
| Secondary | Number of Unplanned Implants Opened During Surgery | During surgery | Number of additional or unplanned implants opened during surgery, including acetabular cups, liners, augments, cages, and screws, where inventory documentation is available. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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