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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

Tracking Information
First Submitted Date May 6, 2019
First Posted Date May 16, 2019
Last Update Posted Date May 17, 2019
Actual Study Start Date April 16, 2019
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 14, 2019)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03951948 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 15, 2019)
  • rate of cortical hypertrophy [ Time Frame: at one year follow-up after Optimys femoral stem surgery ]
    rate of cortical hypertrophy
  • 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
  • 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
  • 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
  • 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)
  • 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)
  • 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)
  • 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)
  • use of walking aids [ Time Frame: at one year follow-up after Optimys femoral stem surgery ]
    clinical outcome defined by use of walking aids
  • 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
Original Secondary Outcome Measures
 (submitted: May 14, 2019)
  • rate of cortical hypertrophy [ Time Frame: at one year follow-up after Optimys femoral stem surgery ]
    rate of cortical hypertrophy
  • 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
  • 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
  • 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
  • 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)
  • 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)
  • 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)
  • 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)
  • use of walking aids [ Time Frame: at one year follow-up after Optimys femoral stem surgery ]
    clinical outcome defined by use of walking aids
  • development 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Optimys Femoral Stem for Total Hip Replacement
Official Title Optimys Femoral Stem for Total Hip Replacement - a Clinical and Radiologic Follow-up of Minimum One Year
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Short Stem Prosthesis
  • Optimys Femoral Stem
Intervention Other: retrospective analysis of surgical performance, clinical and radiologic outcome
retrospective analysis of surgical performance, clinical and radiologic outcome
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 14, 2019)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03951948
Other Study ID Numbers 2019-00563; ch19Saxer
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor University Hospital, Basel, Switzerland
Collaborators Not Provided
Investigators
Principal Investigator: Franziska Saxer, Dr. med University Hospital, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date May 2019