Optimys Femoral Stem for Total Hip Replacement (Optihip)

June 14, 2021 updated by: University Hospital, Basel, Switzerland

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

453

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Time Frame: one year follow-up period after Optimys femoral stem surgery
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
Time Frame: at one year follow-up after Optimys femoral stem surgery
rate of cortical hypertrophy
at one year follow-up after Optimys femoral stem surgery
rate of fractures
Time Frame: one year follow-up period after Optimys femoral stem surgery
rate of fractures after the implantation of short stem femoral implants
one year follow-up period after Optimys femoral stem surgery
rate of infections
Time Frame: one year follow-up period after Optimys femoral stem surgery
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°
Time Frame: at one year follow-up after Optimys femoral stem surgery
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
Time Frame: 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)
at one year follow-up after Optimys femoral stem surgery
pain at rest (yes/no)
Time Frame: at one year follow-up after Optimys femoral stem surgery
clinical outcome defined by pain at rest (yes/no)
at one year follow-up after Optimys femoral stem surgery
pain under stress (yes/no)
Time Frame: at one year follow-up after Optimys femoral stem surgery
clinical outcome defined by pain under stress (yes/no)
at one year follow-up after Optimys femoral stem surgery
use of analgetics (yes/no)
Time Frame: at one year follow-up after Optimys femoral stem surgery
clinical outcome defined by use of analgetics (yes/no)
at one year follow-up after Optimys femoral stem surgery
use of walking aids
Time Frame: at one year follow-up after Optimys femoral stem surgery
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
Time Frame: 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
at one year follow-up after Optimys femoral stem surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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