Optimys Femoral Stem for Total Hip Replacement - a Clinical and Radiologic Follow-up of Minimum One Year

University Hospital, Basel, Switzerland1 site in 1 country453 target enrollmentApril 16, 2019

ConditionsShort Stem Prosthesis Optimys Femoral Stem

Overview

Phase: N/A
Intervention: Not specified
Conditions: Short Stem Prosthesis
Sponsor: University Hospital, Basel, Switzerland
Enrollment: 453
Locations: 1
Primary Endpoint: rate of reoperations
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 16, 2019

End Date

June 9, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University Hospital, Basel, Switzerland

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

rate of reoperations

Time Frame: one year follow-up period after Optimys femoral stem surgery

rate of reoperations after primary implantation of the Optimys short stem prosthesis

Secondary Outcomes

rate of fractures(one year follow-up period after Optimys femoral stem surgery)
rate of infections(one year follow-up period after Optimys femoral stem surgery)
rate of cortical hypertrophy(at one year follow-up after Optimys femoral stem surgery)
pain at rest (yes/no)(at one year follow-up after Optimys femoral stem surgery)
subsidence(at one year follow-up after Optimys femoral stem surgery)
use of walking aids(at one year follow-up after Optimys femoral stem surgery)
anatomic alignment on anterior-posterior (ap) view in Degree°(at one year follow-up after Optimys femoral stem surgery)
pain under stress (yes/no)(at one year follow-up after Optimys femoral stem surgery)
use of analgetics (yes/no)(at one year follow-up after Optimys femoral stem surgery)
extent of periarticular ossification (PAO) according to Brooker classification system(at one year follow-up after Optimys femoral stem surgery)