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

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 Overview

• Status: Completed
• Conditions: Proximal Femoral Fracture
• Intervention / Treatment: Procedure: surgery for femoral neck fracture; Procedure: surgery for pertrochanteric femoral fracture

• Study Type: Observational
• Enrollment (Actual): 2906

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Department of Orthopaedics and Trauma Surgery (DOTS).

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients treated for a proximal femoral fracture at the University Hospital Basel between 01.08.2009 and 31.07.2018

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
surgery for femoral neck fracture; patients with proximal femoral fracture (type: femoral neck fracture) with surgical procedure: partial hip arthroplasty	Procedure: surgery for femoral neck fracture; surgical treatment for proximal femoral fracture with a partial hip arthroplasty in case of femoral neck fractures
surgery for pertrochanteric femoral fractures; 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; surgical treatment for proximal femoral fracture with intramedullary nail type Gamma® Nail or similar in case of pertrochanteric fractures

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Franziska Saxer, Dr. MD, Department of Orthopaedics and Trauma Surgery (DOTS).

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): March 6, 2021
• Study Completion (Actual): March 6, 2021

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: December 6, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): November 4, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: femoral neck fracture; pertrochanteric femoral fracture; risk factor for proximal femoral fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: 2018-00933; ch18Saxer2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No