NCT03951948

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
453

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2021

Completed
Last Updated

June 15, 2021

Status Verified

June 1, 2021

Enrollment Period

2.2 years

First QC Date

May 6, 2019

Last Update Submit

June 14, 2021

Conditions

Short Stem ProsthesisOptimys Femoral Stem

Keywords

total hip replacement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • rate of cortical hypertrophy

    at one year follow-up after Optimys femoral stem surgery

  • 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

  • anatomic alignment on anterior-posterior (ap) view in Degree°

    at one year follow-up after Optimys femoral stem surgery

  • subsidence

    at one year follow-up after Optimys femoral stem surgery

  • +5 more secondary outcomes

Interventions

retrospective analysis of surgical performance, clinical and radiologic outcomeOTHER

retrospective analysis of surgical performance, clinical and radiologic outcome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedics and Trauma Surgery (DOTS).

Basel, 4031, Switzerland

Location

Study Officials

  • Martin Clauss, Dr. med

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2019

First Posted

May 16, 2019

Study Start

April 16, 2019

Primary Completion

June 9, 2021

Study Completion

June 9, 2021

Last Updated

June 15, 2021

Record last verified: 2021-06

Locations

CH(1)