Short Stem ProsthesisOptihipNCT03951948
Optimys Femoral Stem for Total Hip Replacement
An observational study of Short Stem Prosthesis and Optimys Femoral Stem, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Short Stem Prosthesis, Optimys Femoral Stem
- What is being tested?
- retrospective analysis of surgical performance, clinical and radiologic outcome
- How many people
- 453 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Apr 2019to 9 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients treated with an Optimys femoral component at the University Hospital Basel between 29.10.2013 and 29.10.2018
Who cannot join
- Clinical follow up at another Institution
- Documented dissent in study participation
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Orthopaedics and Trauma Surgery (DOTS).
Basel, 4031
About this study
Official title: Optimys Femoral Stem for Total Hip Replacement - a Clinical and Radiologic Follow-up of Minimum One Year
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.
- Conditions
- Short Stem Prosthesis, Optimys Femoral Stem
- Being tested
- retrospective analysis of surgical performance, clinical and radiologic outcome
- Keywords
- total hip replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective analysis of surgical performance, clinical and radiologic outcomeOther
retrospective analysis of surgical performance, clinical and radiologic outcome
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of reoperations
rate of reoperations after primary implantation of the Optimys short stem prosthesis
Measured: one year follow-up period after Optimys femoral stem surgery
Secondary outcomes (10)
rate of cortical hypertrophy
rate of cortical hypertrophy
Measured: at one year follow-up after Optimys femoral stem surgery
rate of fractures
rate of fractures after the implantation of short stem femoral implants
Measured: one year follow-up period after Optimys femoral stem surgery
rate of infections
rate of infections after the implantation of short stem femoral implants
Measured: one year follow-up period after Optimys femoral stem surgery
anatomic alignment on anterior-posterior (ap) view in Degree°
radiologic outcome defined by preciseness of the anatomic alignment compared to the contralateral side
Measured: at one year follow-up after Optimys femoral stem surgery
subsidence
radiologic outcome defined by rate of subsidence after the implantation of short stem femoral implants (mm)
Measured: at one year follow-up after Optimys femoral stem surgery
pain at rest (yes/no)
clinical outcome defined by pain at rest (yes/no)
Measured: at one year follow-up after Optimys femoral stem surgery
pain under stress (yes/no)
clinical outcome defined by pain under stress (yes/no)
Measured: at one year follow-up after Optimys femoral stem surgery
use of analgetics (yes/no)
clinical outcome defined by use of analgetics (yes/no)
Measured: at one year follow-up after Optimys femoral stem surgery
use of walking aids
clinical outcome defined by use of walking aids
Measured: at one year follow-up after Optimys femoral stem surgery
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
Measured: at one year follow-up after Optimys femoral stem surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start16 Apr 2019
- Primary completion9 Jun 2021
- Study completion9 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Stem ProsthesisStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Clauss, Dr. med, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951948
- Sponsor's protocol ID
- 2019-00563; ch19Saxer
- Other IDs
- 2019
- Acronym
- Optihip
- Status last verified
- Jun 2021
- First submitted
- 6 May 2019
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimys Femoral Stem for Total Hip Replacement - a Clinical and Radiologic Follow-up of Minimum One Year
- ClinicalTrials.gov ID
- NCT03951948
- Acronym / sponsor ID
- Optihip / 2019-00563; ch19Saxer
- Conditions
- Short Stem Prosthesis, Optimys Femoral Stem
- Keywords
- total hip replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients treated with an Optimys femoral component at the University Hospital Basel between 29.10.2013 and 29.10.2018
Key exclusion criteria (2 listed)
- Clinical follow up at another Institution
- Documented dissent in study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retrospective analysis of surgical performance, clinical and radiologic outcomeretrospective analysis of surgical performance, clinical and radiologic outcome | Other | – |
Primary outcome
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
10 secondary outcomes
rate of cortical hypertrophy
Time frame: at one year follow-up after Optimys femoral stem surgery
rate of fractures
Time frame: one year follow-up period after Optimys femoral stem surgery
rate of infections
Time frame: one year follow-up period after Optimys femoral stem surgery
anatomic alignment on anterior-posterior (ap) view in Degree°
Time frame: at one year follow-up after Optimys femoral stem surgery
subsidence
Time frame: at one year follow-up after Optimys femoral stem surgery
pain at rest (yes/no)
Time frame: at one year follow-up after Optimys femoral stem surgery
pain under stress (yes/no)
Time frame: at one year follow-up after Optimys femoral stem surgery
use of analgetics (yes/no)
Time frame: at one year follow-up after Optimys femoral stem surgery
use of walking aids
Time frame: at one year follow-up after Optimys femoral stem surgery
extent of periarticular ossification (PAO) according to Brooker classification system
Time frame: at one year follow-up after Optimys femoral stem surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Clauss, Dr. med principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Short Stem Prosthesis and Optimys Femoral Stem, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of reoperations (time frame: one year follow-up period after Optimys femoral stem surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021; AzTrials last refreshed its copy on 1 Nov 2026.