Optimys Femoral Stem for Total Hip Replacement (Optihip)

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

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.

Study Overview

• Status: Completed
• Conditions: Short Stem Prosthesis; Optimys Femoral Stem
• Intervention / Treatment: Other: retrospective analysis of surgical performance, clinical and radiologic outcome

• Study Type: Observational
• Enrollment (Actual): 453

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Department of Orthopaedics and Trauma Surgery (DOTS).

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients treated for a proximal femoral fracture at the University Hospital Basel between 29.10.2013 (date of introduction of the Optimys femoral component at the university hospital Basel) and 29.10.2018.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of reoperations	rate of reoperations after primary implantation of the Optimys short stem prosthesis	one year follow-up period after Optimys femoral stem surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of cortical hypertrophy	rate of cortical hypertrophy	at one year follow-up after Optimys femoral stem surgery
rate of fractures	rate of fractures after the implantation of short stem femoral implants	one year follow-up period after Optimys femoral stem surgery
rate of infections	rate of infections after the implantation of short stem femoral implants	one year follow-up period after Optimys femoral stem surgery
anatomic alignment on anterior-posterior (ap) view in Degree°	radiologic outcome defined by preciseness of the anatomic alignment compared to the contralateral side	at one year follow-up after Optimys femoral stem surgery
subsidence	radiologic outcome defined by rate of subsidence after the implantation of short stem femoral implants (mm)	at one year follow-up after Optimys femoral stem surgery
pain at rest (yes/no)	clinical outcome defined by pain at rest (yes/no)	at one year follow-up after Optimys femoral stem surgery
pain under stress (yes/no)	clinical outcome defined by pain under stress (yes/no)	at one year follow-up after Optimys femoral stem surgery
use of analgetics (yes/no)	clinical outcome defined by use of analgetics (yes/no)	at one year follow-up after Optimys femoral stem surgery
use of walking aids	clinical outcome defined by use of walking aids	at one year follow-up after Optimys femoral stem surgery
extent of periarticular ossification (PAO) according to Brooker classification system	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	at one year follow-up after Optimys femoral stem surgery

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Martin Clauss, Dr. med, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2019
• Primary Completion (Actual): June 9, 2021
• Study Completion (Actual): June 9, 2021

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Actual): June 15, 2021
• Last Update Submitted That Met QC Criteria: June 14, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: total hip replacement
• Other Study ID Numbers: 2019-00563; ch19Saxer

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No