Optimys Femoral Stem Clinical Trial
— OptihipOfficial title:
Optimys Femoral Stem for Total Hip Replacement - a Clinical and Radiologic Follow-up of Minimum One Year
| Verified date | June 2021 |
| Source | University Hospital, Basel, Switzerland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 453 |
| Est. completion date | June 9, 2021 |
| Est. primary completion date | June 9, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Department of Orthopaedics and Trauma Surgery (DOTS). | Basel |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Basel, Switzerland |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | rate of cortical hypertrophy | rate of cortical hypertrophy | at one year follow-up after Optimys femoral stem surgery | |
| Secondary | rate of fractures | rate of fractures after the implantation of short stem femoral implants | one year follow-up period after Optimys femoral stem surgery | |
| Secondary | rate of infections | rate of infections after the implantation of short stem femoral implants | one year follow-up period after Optimys femoral stem surgery | |
| Secondary | anatomic alignment on anterior-posterior (ap) view in Degree° | radiologic outcome defined by preciseness of the anatomic alignment compared to the contralateral side | at one year follow-up after Optimys femoral stem surgery | |
| Secondary | subsidence | radiologic outcome defined by rate of subsidence after the implantation of short stem femoral implants (mm) | at one year follow-up after Optimys femoral stem surgery | |
| Secondary | pain at rest (yes/no) | clinical outcome defined by pain at rest (yes/no) | at one year follow-up after Optimys femoral stem surgery | |
| Secondary | pain under stress (yes/no) | clinical outcome defined by pain under stress (yes/no) | at one year follow-up after Optimys femoral stem surgery | |
| Secondary | use of analgetics (yes/no) | clinical outcome defined by use of analgetics (yes/no) | at one year follow-up after Optimys femoral stem surgery | |
| Secondary | use of walking aids | clinical outcome defined by use of walking aids | at one year follow-up after Optimys femoral stem surgery | |
| Secondary | extent of periarticular ossification (PAO) according to Brooker classification system | 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 |
at one year follow-up after Optimys femoral stem surgery |