Long-term Outcomes of Conical Tapered Stems in Cementless Total Hip Arthroplasty Due to Congenital Hip Pathologies

Completed

• Conditions: Dysplasia; Hip; Prosthesis Survival
• Interventions: Device: Conical tapered stem

• Registration Number: NCT04748458
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

A retrospective consecutive population of patients treated with conical tapered stems in cementless total hip arthroplasty for osteoarthritis due to congenital hip pathologies will be selected. The aim of this retrospective study is to evaluate the long-term clinical and radiographic results of this implant and the survival rates in such a specific cohort.

Detailed Description

Congenital hip pathologies may severely alter the local anatomy of the hip, making total hip arthroplasty (THA) due to osteoarthritis after congenital hip pathologies challenging. While it seems that congenital hip pathologies did not significantly influence the outcomes when compared to THA after osteoarthritis, the choice of implant was demonstrated to impact the survival rates of the THA after congenital hip pathologies.

To date, no guidelines exist about the correct choice of hip implant in congenital hip pathologies: only mid-term case series are available. Conical tapered stems have been frequently suggested for the most difficult cases.

The aim of this study is to describe the survival rates and the long-term clinical and radiological outcome of conical tapered stems in THAs after congenital hip pathologies.

Study Timeline

• Study Start: 2020-07-17
• Status Verified: 2020-10
• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2021-02-06
• Study First Posted: 2021-02-10
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-02
• Results First Submitted: 2021-10-05
• Results First Submitted QC: 2022-03-21
• Last Update Submitted: 2022-03-21
• Results First Posted: 2022-03-22
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Symptomatic hip osteoarthritis due to congenital hip pathologies
• Consecutive population with a minimum follow-up of 2 years
• Cementless total hip arthroplasty with conical tapered stem
• Pre-operative planning using CT
• Complete clinical and radiographic assessment

Exclusion Criteria

• Other type of hip osteoarthritis
• Other type of implants
• Inadequate pre-operative planning (eg: no CT)
• Incomplete clinical and radiographic assessment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Congenital hip pathologies	Conical tapered stem	Conical tapered stem for osteoarthritis due to congenital hip pathologies

Primary Outcome Measures

Name	Time	Method
Harris Hip Score	15 months	Mean clinical results at last follow-up evaluated using the Harris hip score. Minimum-maximum values: 0-100. Best result: 100.
Radiographic Cup Osseointegration	15 months	Osseointegrated cups described using the Moore's criteria: the cup is osseointegrated when at least 3 criteria are present (radial trabeculae, superolateral buttress, inferolateral buttress, medial stress shielding, absence of radiolucent lines).
Radiographic Stem Osseointegration	15 months	Osseointegrated stems described according to Engh's criteria
Survival Rate	15 months	Percentage of survived implants (no component exchange or removed) described using Kaplan-Meier curve with 95% confidence interval. Minimum-maximum values: 0-100. Best result: 100.

Trial Locations

Locations (1)

Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy; 🇮🇹 Bologna, Italy