Proximal Femoral FractureProFiNCT03768622
Proximal Femoral Fractures - Patient Population, Risk Factors, Surgical Performance and Outcome
An observational study of Proximal Femoral Fracture, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Proximal femoral fractures are a typical pathology in elderly patients after a low-energy trauma. This study analyses preexisting risk factors for proximal femoral fractures as well as for failing to reach the previous functional level, difference in outcome between patients with femoral neck fracture compared to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Proximal Femoral Fracture
- What is being tested?
- surgery for pertrochanteric femoral fracture and surgery for femoral neck fracture
- Type of treatment
- Surgery or procedure
- How many people
- 2,906 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2018to 6 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated for a proximal femoral fracture at the University Hospital Basel between 01.08.2009 and 31.07.2018
Who may be able to join
- surgery with intramedullary nail type Gamma® Nail or similar in case of pertrochanteric fractures or
- with a partial hip arthroplasty in case of femoral neck fractures
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
Proximal femoral fractures are a typical pathology in elderly patients after a low-energy trauma.
This study analyses preexisting risk factors for proximal femoral fractures as well as for failing to reach the previous functional level, difference in outcome between patients with femoral neck fracture compared to those with pertrochanteric fracture, surgical performance and its significance for the functional outcome, as well as the impact of proximal femoral fractures on patients' one-year independence.
- Conditions
- Proximal Femoral Fracture
- Being tested
- surgery for pertrochanteric femoral fracture, surgery for femoral neck fracture
- Keywords
- femoral neck fracture, pertrochanteric femoral fracture, risk factor for proximal femoral fracture
- Medical subject headings
- Proximal Femoral Fractures, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery for pertrochanteric femoral fractureProcedure or surgery
surgical treatment for proximal femoral fracture with intramedullary nail type Gamma® Nail or similar in case of pertrochanteric fractures
surgery for femoral neck fractureProcedure or surgery
surgical treatment for proximal femoral fracture with a partial hip arthroplasty in case of femoral neck fractures
| Study group | Role | What they receive |
|---|---|---|
| surgery for femoral neck fracture | patients with proximal femoral fracture (type: femoral neck fracture) with surgical procedure: partial hip arthroplasty Receives: Procedure: surgery for femoral neck fracture | |
| surgery for pertrochanteric femoral fractures | patients with proximal femoral fracture (type:pertrochanteric femoral fractures) with surgical procedure: intramedullary nail type Gamma® Nail or similar Receives: Procedure: surgery for pertrochanteric femoral fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient clinical outcome
Quantification of Rehospitalizations
Measured: from date of surgery until 1 year follow up period after surgery
Change in Patient clinical outcome
Change in living situation
Measured: at 1 year follow up date after surgery
Change in Patient clinical outcome
Quantification of major complications with documentation of affected organ System, intensive care Treatment, Discharge where to (home, home with support, in-patient rehabilitation, nursing home), length of hospital stay
Measured: during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)
Change in Patient clinical outcome
Quantification of Reoperations
Measured: from date of surgery until 1 year follow up period after surgery
Change in Patient clinical outcome
Quantification of infections
Measured: from date of surgery until 1 year follow up period after surgery
Change in Patient clinical outcome
Quantification of deaths and date of death
Measured: from date of surgery until 1 year follow up period after surgery
Change in Patient clinical outcome
Change in use of walking aids
Measured: at 1 year follow up date after surgery
Change in Patient clinical outcome
Change in pain at rest (yes/no),
Measured: at 1 year follow up date after surgery
Change in Patient clinical outcome
Change in pain under stress (yes/no)
Measured: at 1 year follow up date after surgery
Change in Patient clinical outcome
Change in restrictions in daily living (yes/no),
Measured: at 1 year follow up date after surgery
Change in Patient clinical outcome
Change in use of analgetics (yes/no)
Measured: at 1 year follow up date after surgery
Change in Patient clinical outcome
Quantification of intensive care Treatment
Measured: during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)
Change in Patient clinical outcome
Quantification of Discharge where to (home, home with support, in-patient rehabilitation, nursing home)
Measured: during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)
Change in Patient clinical outcome
Quantification of length of hospital stay
Measured: during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)
Secondary outcomes (10)
Change in patient clinical outcome (according Penrod score)
Penrod score reflects the patients' preoperative functional level and living. Patients are classified concerning their prefracture age (1: <75 years, 2: 75-84 years, 3 ≥85 years, their ability in performing activities of daily life (ADL) as well as their cognitive status (dementia in clusters 2B and 3D Situation)
Measured: preoperatively and at 1 year follow up date after surgery
Change in radiological outcome: assessment of surgical treatment of pertrochanteric fractures
central positioning and insertion of the neck screw
Measured: day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)
radiological outcome: assessment of surgical treatment of femoral neck fractures
development of periacetabular ossification according to Brooker
- 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: 1year postoperative (if n.a. min 6 months postoperative)
Change in subsidence (radiological outcome: assessment of surgical treatment of femoral neck fractures)
differences in the distance between perpendicular lines drawn to the bisecting axis of the medullary canal, at the top of the femoral head and at the tip of the great trochanter in mm
Measured: 1year postoperative (if n.a. min 6 months postoperative)
radiological outcome: assessment of surgical treatment of femoral neck fractures
cortical atrophy i.e. longitudinal intracortical porosis with a consecutive thinning of the cortex without measurable thickening of the femur (yes-no-n.a.)
Measured: 1year postoperative (if n.a. min 6 months postoperative)
radiological outcome: assessment of surgical treatment of femoral neck fractures
osteolysis i.e. progressive, newly developed endosteal bone loss with a diameter > 3 mm, either with scalloping or a bead-shaped lucency at the cement-bone interface
Measured: 1year postoperative (if n.a. min 6 months postoperative)
radiological outcome: assessment of surgical treatment of femoral neck fractures
debonding i.e. radiolucent line at the prosthesis-cement interface not visible on the first postoperative radiograph (yes-no-n.a.)
Measured: 1year postoperative (if n.a. min 6 months postoperative)
Change in radiological outcome: assessment of surgical treatment of pertrochanteric fractures
leg-length discrepancy (tangent to inferior pubic rami and tip of greater trochanter, if n.a. insertion of lesser trochanter)
Measured: day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)
Change in radiological outcome: assessment of surgical treatment of femoral neck fractures
leg-length discrepancy in mm (tangent to inferior pubic rami and tip of greater trochanter, if n.a. insertion of lesser trochanter)
Measured: day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)
Change in radiological outcome: assessment of surgical treatment of femoral neck fractures
alignment on ap view (central axis of the distal stem to bisecting axis of medullary canal at the isthmus) in °
Measured: day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start1 Jun 2018
- Primary completion6 Mar 2021
- Study completion6 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Femoral FractureStudies 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
- 2,906 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franziska Saxer, Dr. MD, Principal investigator, Department of Orthopaedics and Trauma Surgery (DOTS).
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768622
- Sponsor's protocol ID
- 2018-00933; ch18Saxer2
- Other IDs
- 2018
- Acronym
- ProFi
- Status last verified
- Nov 2021
- First submitted
- 23 Oct 2018
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Femoral Fractures - Patient Population, Risk Factors, Surgical Performance and Outcome
- ClinicalTrials.gov ID
- NCT03768622
- Acronym / sponsor ID
- ProFi / 2018-00933; ch18Saxer2
- Conditions
- Proximal Femoral Fracture
- Keywords
- femoral neck fracture, pertrochanteric femoral fracture, risk factor for proximal femoral fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,906 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 6 Mar 2021 (actual)
- Study completion
- 6 Mar 2021 (actual)
- First posted
- 7 Dec 2018 (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.
Proximal femoral fractures are a typical pathology in elderly patients after a low-energy trauma.
This study analyses preexisting risk factors for proximal femoral fractures as well as for failing to reach the previous functional level, difference in outcome between patients with femoral neck fracture compared to those with pertrochanteric fracture, surgical performance and its significance for the functional outcome, as well as the impact of proximal femoral fractures on patients' one-year independence.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery for femoral neck fracture | – | Procedure: surgery for femoral neck fracturepatients with proximal femoral fracture (type: femoral neck fracture) with surgical procedure: partial hip arthroplasty |
| surgery for pertrochanteric femoral fractures | – | Procedure: surgery for pertrochanteric femoral fracturepatients with proximal femoral fracture (type:pertrochanteric femoral fractures) with surgical procedure: intramedullary nail type Gamma® Nail or similar |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated for a proximal femoral fracture at the University Hospital Basel between 01.08.2009 and 31.07.2018
Key inclusion criteria (2 listed)
- surgery with intramedullary nail type Gamma® Nail or similar in case of pertrochanteric fractures or
- with a partial hip arthroplasty in case of femoral neck fractures
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 |
|---|---|---|
| surgery for pertrochanteric femoral fracturesurgical treatment for proximal femoral fracture with intramedullary nail type Gamma® Nail or similar in case of pertrochanteric fractures | Procedure or surgery | surgery for pertrochanteric femoral fractures |
| surgery for femoral neck fracturesurgical treatment for proximal femoral fracture with a partial hip arthroplasty in case of femoral neck fractures | Procedure or surgery | surgery for femoral neck fracture |
Primary outcome
Change in Patient clinical outcome
Time frame: from date of surgery until 1 year follow up period after surgery
Quantification of Rehospitalizations
Change in Patient clinical outcome
Time frame: at 1 year follow up date after surgery
Change in living situation
Change in Patient clinical outcome
Time frame: during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)
Quantification of major complications with documentation of affected organ System, intensive care Treatment, Discharge where to (home, home with support, in-patient rehabilitation, nursing home), length of hospital stay
Change in Patient clinical outcome
Time frame: from date of surgery until 1 year follow up period after surgery
Quantification of Reoperations
Change in Patient clinical outcome
Time frame: from date of surgery until 1 year follow up period after surgery
Quantification of infections
Change in Patient clinical outcome
Time frame: from date of surgery until 1 year follow up period after surgery
Quantification of deaths and date of death
Change in Patient clinical outcome
Time frame: at 1 year follow up date after surgery
Change in use of walking aids
Change in Patient clinical outcome
Time frame: at 1 year follow up date after surgery
Change in pain at rest (yes/no),
Change in Patient clinical outcome
Time frame: at 1 year follow up date after surgery
Change in pain under stress (yes/no)
Change in Patient clinical outcome
Time frame: at 1 year follow up date after surgery
Change in restrictions in daily living (yes/no),
Change in Patient clinical outcome
Time frame: at 1 year follow up date after surgery
Change in use of analgetics (yes/no)
Change in Patient clinical outcome
Time frame: during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)
Quantification of intensive care Treatment
Change in Patient clinical outcome
Time frame: during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)
Quantification of Discharge where to (home, home with support, in-patient rehabilitation, nursing home)
Change in Patient clinical outcome
Time frame: during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)
Quantification of length of hospital stay
10 secondary outcomes
Change in patient clinical outcome (according Penrod score)
Time frame: preoperatively and at 1 year follow up date after surgery
Change in radiological outcome: assessment of surgical treatment of pertrochanteric fractures
Time frame: day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)
radiological outcome: assessment of surgical treatment of femoral neck fractures
Time frame: 1year postoperative (if n.a. min 6 months postoperative)
Change in subsidence (radiological outcome: assessment of surgical treatment of femoral neck fractures)
Time frame: 1year postoperative (if n.a. min 6 months postoperative)
radiological outcome: assessment of surgical treatment of femoral neck fractures
Time frame: 1year postoperative (if n.a. min 6 months postoperative)
radiological outcome: assessment of surgical treatment of femoral neck fractures
Time frame: 1year postoperative (if n.a. min 6 months postoperative)
radiological outcome: assessment of surgical treatment of femoral neck fractures
Time frame: 1year postoperative (if n.a. min 6 months postoperative)
Change in radiological outcome: assessment of surgical treatment of pertrochanteric fractures
Time frame: day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)
Change in radiological outcome: assessment of surgical treatment of femoral neck fractures
Time frame: day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)
Change in radiological outcome: assessment of surgical treatment of femoral neck fractures
Time frame: day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)
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 4 Nov 2021.
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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.
Franziska Saxer, Dr. MD principal investigator
Department of Orthopaedics and Trauma Surgery (DOTS).
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 Proximal Femoral Fracture, 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 2 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 4 Nov 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?
Change in Patient clinical outcome (time frame: from date of surgery until 1 year follow up period after surgery). The study lists 14 primary outcomes in all. 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 4 Nov 2021.