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NCT Number: NCT03951948

Optimys Femoral Stem for Total Hip Replacement

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.

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Key information

Conditions

Short Stem Prosthesis Optimys Femoral Stem

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Orthopaedics and Trauma Surgery (DOTS).

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

retrospective analysis of surgical performance, clinical and radiologic outcome

Other

retrospective analysis of surgical performance, clinical and radiologic outcome

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: Optihip

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 16, 2019
Registry last updated
Jun 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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