N/A
Completed N=150
Biomechanical Reconstruction of Three Different Hip Stem Designs in Hip Dysplasia Using a 3D CT-based Planning Software
Dysplasia; Hip
Source: ClinicalTrials.gov NCT04904640 ↗
Enrolled (actual)
150
Serious AEs
—
Results posted
Sep 2021
Primary outcomePrimary: Correct Reconstruction CLS — 138 Hips
Summary
A random population of 200 CT scans of pelvis and thigh in an adult population affected by hip dysplasia will be selected. The aim of this study is to evaluate the biomechanical reconstruction of the hip anatomy provided by three different hip stem designs in dysplastic cases, using a 3D CT based software for pre-operative planning.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correct Reconstruction CLS |
138 | — |
| PRIMARY Correct Reconstruction Wagner Cone |
174 | — |
| PRIMARY Correct Reconstruction Aptafix |
88 | — |
| SECONDARY Combined Anteversion CLS |
153 | — |
| SECONDARY Combined Anteversion Wagner Cone |
197 | — |
| SECONDARY Combined Anteversion Aptafix |
121 | — |
| SECONDARY Offset CLS |
192 | — |
| SECONDARY Offset Wagner Cone |
186 | — |
| SECONDARY Offset Aptafix |
164 | — |
| SECONDARY Leg Lengthening CLS |
188 | — |
| SECONDARY Leg Lengthening Wagner Cone |
194 | — |
| SECONDARY Leg Lengthening Aptafix |
183 | — |
Eligibility Criteria
Inclusion Criteria
- definition of developmental hip dysplasia according to Wiberg (center edge angle <20°)
- pre-operative CT scan extended from the fourth lumbar vertebra to the tibial plateaus
Exclusion Criteria
- other types of hip pathologies
- inadequate Ct scans
Data sourced from ClinicalTrials.gov (NCT04904640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.