N/A N=150

Biomechanical Reconstruction of Three Different Hip Stem Designs in Hip Dysplasia Using a 3D CT-based Planning Software

Dysplasia; Hip

Bottom Line

View on ClinicalTrials.gov: NCT04904640 ↗

Enrolled (actual)

150

Serious AEs

—

Results posted

Sep 2021

Primary outcome: Primary: Correct Reconstruction CLS — 138 Hips

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Hip stem (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Istituto Ortopedico Rizzoli
Primary completion: Jul 2021

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	—

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.

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

View full record on ClinicalTrials.gov →

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.