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Optimys Femoral Stem for Total Hip Replacement (Optihip)

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ClinicalTrials.gov Identifier: NCT03951948
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment
Short Stem Prosthesis Optimys Femoral Stem Other: retrospective analysis of surgical performance, clinical and radiologic outcome

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Optimys Femoral Stem for Total Hip Replacement - a Clinical and Radiologic Follow-up of Minimum One Year
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement


Intervention Details:
  • Other: retrospective analysis of surgical performance, clinical and radiologic outcome
    retrospective analysis of surgical performance, clinical and radiologic outcome


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. rate of cortical hypertrophy [ Time Frame: at one year follow-up after Optimys femoral stem surgery ]
    rate of cortical hypertrophy

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. use of walking aids [ Time Frame: at one year follow-up after Optimys femoral stem surgery ]
    clinical outcome defined by use of walking aids

  10. 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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951948


Contacts
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Contact: Franziska Saxer, Dr. med +41 61 265 25 25 franziska.saxer@usb.ch
Contact: Marcel Jakob, Prof. Dr. MD +41 61 265 25 25 marcel.jakob@usb.ch

Locations
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Switzerland
Department of Orthopaedics and Trauma Surgery (DOTS). Recruiting
Basel, Switzerland, 4031
Contact: Franziska Saxer, Dr. med    +41 061 328 62 43    Franziska.saxer@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Franziska Saxer, Dr. med University Hospital, Basel, Switzerland

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03951948     History of Changes
Other Study ID Numbers: 2019-00563; ch19Saxer
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Basel, Switzerland:
total hip replacement