Optimys Femoral Stem for Total Hip Replacement

Completed

• Conditions: Short Stem Prosthesis; Optimys Femoral Stem

• Registration Number: NCT03951948
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

This retrospective observational study analyses the surgical performance, clinical and radiologic outcome as well as the rate of infections with a main focus on revision surgeries after primary implantation of the Optimys short stem femoral prosthesis.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-16
• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-16
• Status Verified: 2021-06
• Primary Completion: 2021-06-09
• Study Completion: 2021-06-09
• Last Update Submitted: 2021-06-14
• Last Update Posted: 2021-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 453

Inclusion Criteria

• Patients treated with an Optimys femoral component at the University Hospital Basel between 29.10.2013 and 29.10.2018

Exclusion Criteria

• Clinical follow up at another Institution
• Documented dissent in study participation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rate of reoperations	one year follow-up period after Optimys femoral stem surgery	rate of reoperations after primary implantation of the Optimys short stem prosthesis

Secondary Outcome Measures

Name	Time	Method
rate of fractures	one year follow-up period after Optimys femoral stem surgery	rate of fractures after the implantation of short stem femoral implants
rate of infections	one year follow-up period after Optimys femoral stem surgery	rate of infections after the implantation of short stem femoral implants
rate of cortical hypertrophy	at one year follow-up after Optimys femoral stem surgery	rate of cortical hypertrophy
pain at rest (yes/no)	at one year follow-up after Optimys femoral stem surgery	clinical outcome defined by pain at rest (yes/no)
subsidence	at one year follow-up after Optimys femoral stem surgery	radiologic outcome defined by rate of subsidence after the implantation of short stem femoral implants (mm)
use of walking aids	at one year follow-up after Optimys femoral stem surgery	clinical outcome defined by use of walking aids
anatomic alignment on anterior-posterior (ap) view in Degree°	at one year follow-up after Optimys femoral stem surgery	radiologic outcome defined by preciseness of the anatomic alignment compared to the contralateral side
pain under stress (yes/no)	at one year follow-up after Optimys femoral stem surgery	clinical outcome defined by pain under stress (yes/no)
use of analgetics (yes/no)	at one year follow-up after Optimys femoral stem surgery	clinical outcome defined by use of analgetics (yes/no)
extent of periarticular ossification (PAO) according to Brooker classification system	at one year follow-up after Optimys femoral stem surgery	Brooker classification system divides severity of PAO into 4 types: A: islands of bone within the soft tissues about the hip B: bone spurs originating from the pelvis or proximal end of the femur, leaving at least 1 cm between opposing bone surfaces C: bone spurs originating from the pelvis or proximal end of the femur, reducing the space between opposing bone surfaces to less than 1 cm D: bone ankylosis of the hip

Trial Locations

Locations (1)

Department of Orthopaedics and Trauma Surgery (DOTS).; 🇨🇭 Basel, Switzerland