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Optimys Femoral Stem for Total Hip Replacement

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03951948
Acronym
Optihip
Enrollment
453
Registered
2019-05-16
Start date
2019-04-16
Completion date
2021-06-09
Last updated
2021-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Optimys Femoral Stem, Short Stem Prosthesis

Keywords

total hip replacement

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.

Interventions

OTHERretrospective analysis of surgical performance, clinical and radiologic outcome

retrospective analysis of surgical performance, clinical and radiologic outcome

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
rate of reoperationsone year follow-up period after Optimys femoral stem surgeryrate of reoperations after primary implantation of the Optimys short stem prosthesis

Secondary

MeasureTime frameDescription
rate of fracturesone year follow-up period after Optimys femoral stem surgeryrate of fractures after the implantation of short stem femoral implants
rate of infectionsone year follow-up period after Optimys femoral stem surgeryrate of infections after the implantation of short stem femoral implants
anatomic alignment on anterior-posterior (ap) view in Degree°at one year follow-up after Optimys femoral stem surgeryradiologic outcome defined by preciseness of the anatomic alignment compared to the contralateral side
subsidenceat one year follow-up after Optimys femoral stem surgeryradiologic outcome defined by rate of subsidence after the implantation of short stem femoral implants (mm)
rate of cortical hypertrophyat one year follow-up after Optimys femoral stem surgeryrate of cortical hypertrophy
pain under stress (yes/no)at one year follow-up after Optimys femoral stem surgeryclinical outcome defined by pain under stress (yes/no)
use of analgetics (yes/no)at one year follow-up after Optimys femoral stem surgeryclinical outcome defined by use of analgetics (yes/no)
use of walking aidsat one year follow-up after Optimys femoral stem surgeryclinical outcome defined by use of walking aids
extent of periarticular ossification (PAO) according to Brooker classification systemat one year follow-up after Optimys femoral stem surgeryBrooker 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
pain at rest (yes/no)at one year follow-up after Optimys femoral stem surgeryclinical outcome defined by pain at rest (yes/no)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026