Proximal Femoral Fractures - Patient Population, Risk Factors, Surgical Performance and Outcome

Study Overview
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Brief Summary
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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.

Official Title
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Proximal Femoral Fractures - Patient Population, Risk Factors, Surgical Performance and Outcome

Conditions
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Proximal Femoral Fracture

Intervention / Treatment
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* Procedure: surgery for pertrochanteric femoral fracture
* Procedure: surgery for femoral neck fracture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Clinical follow up at another institution Documented dissent in study participation
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| surgery for femoral neck fracture<br>patients with proximal femoral fracture (type: femoral neck fracture) with surgical procedure: partial hip arthroplasty | Procedure: surgery for femoral neck fracture<br>* surgical treatment for proximal femoral fracture with a partial hip arthroplasty in case of femoral neck fractures<br>|
| surgery for pertrochanteric femoral fractures<br>patients with proximal femoral fracture (type:pertrochanteric femoral fractures) with surgical procedure: intramedullary nail type Gamma® Nail or similar | Procedure: surgery for pertrochanteric femoral fracture<br>* surgical treatment for proximal femoral fracture with intramedullary nail type Gamma® Nail or similar in case of pertrochanteric fractures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient clinical outcome | Quantification of Rehospitalizations | from date of surgery until 1 year follow up period after surgery | 
| Change in Patient clinical outcome | Change in living situation | 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 | during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks) | 
| Change in Patient clinical outcome | Quantification of Reoperations | from date of surgery until 1 year follow up period after surgery | 
| Change in Patient clinical outcome | Quantification of infections | from date of surgery until 1 year follow up period after surgery | 
| Change in Patient clinical outcome | Quantification of deaths and date of death | from date of surgery until 1 year follow up period after surgery | 
| Change in Patient clinical outcome | Change in use of walking aids | at 1 year follow up date after surgery | 
| Change in Patient clinical outcome | Change in pain at rest (yes/no), | at 1 year follow up date after surgery | 
| Change in Patient clinical outcome | Change in pain under stress (yes/no) | at 1 year follow up date after surgery | 
| Change in Patient clinical outcome | Change in restrictions in daily living (yes/no), | at 1 year follow up date after surgery | 
| Change in Patient clinical outcome | Change in use of analgetics (yes/no) | at 1 year follow up date after surgery | 
| Change in Patient clinical outcome | Quantification of intensive care Treatment | 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) | 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 | during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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 | 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 | 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.) | 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 | 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.) | 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) | 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) | 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 ° | day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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femoral neck fracture, pertrochanteric femoral fracture, risk factor for proximal femoral fracture