Clinical trial NCT03768622: Proximal Femoral Fractures - Patient Population, Risk Factors, Surgical Performance and Outcome
Official title: Proximal Femoral Fractures - Patient Population, Risk Factors, Surgical Performance and Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proximal Femoral Fracture
Keywords: femoral neck fracture
pertrochanteric femoral fracture
risk factor for proximal femoral fracture
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 2906
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

Brief 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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Patient clinical outcome
timeFrame: from date of surgery until 1 year follow up period after surgery
measure: Change in Patient clinical outcome
timeFrame: at 1 year follow up date after surgery
measure: Change in Patient clinical outcome
timeFrame: during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)
measure: Change in Patient clinical outcome
timeFrame: from date of surgery until 1 year follow up period after surgery
measure: Change in Patient clinical outcome
timeFrame: from date of surgery until 1 year follow up period after surgery
measure: Change in Patient clinical outcome
timeFrame: from date of surgery until 1 year follow up period after surgery
measure: Change in Patient clinical outcome
timeFrame: at 1 year follow up date after surgery
measure: Change in Patient clinical outcome
timeFrame: at 1 year follow up date after surgery
measure: Change in Patient clinical outcome
timeFrame: at 1 year follow up date after surgery
measure: Change in Patient clinical outcome
timeFrame: at 1 year follow up date after surgery
measure: Change in Patient clinical outcome
timeFrame: at 1 year follow up date after surgery
measure: Change in Patient clinical outcome
timeFrame: during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)
measure: Change in Patient clinical outcome
timeFrame: during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)
measure: Change in Patient clinical outcome
timeFrame: during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)
Secondary outcomes:
measure: Change in patient clinical outcome (according Penrod score)
timeFrame: preoperatively and at 1 year follow up date after surgery
measure: Change in radiological outcome: assessment of surgical treatment of pertrochanteric fractures
timeFrame: day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)
measure: radiological outcome: assessment of surgical treatment of femoral neck fractures
timeFrame: 1year postoperative (if n.a. min 6 months postoperative)
measure: Change in subsidence (radiological outcome: assessment of surgical treatment of femoral neck fractures)
timeFrame: 1year postoperative (if n.a. min 6 months postoperative)
measure: radiological outcome: assessment of surgical treatment of femoral neck fractures
timeFrame: 1year postoperative (if n.a. min 6 months postoperative)
measure: radiological outcome: assessment of surgical treatment of femoral neck fractures
timeFrame: 1year postoperative (if n.a. min 6 months postoperative)
measure: radiological outcome: assessment of surgical treatment of femoral neck fractures
timeFrame: 1year postoperative (if n.a. min 6 months postoperative)
measure: Change in radiological outcome: assessment of surgical treatment of pertrochanteric fractures
timeFrame: day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)
measure: Change in radiological outcome: assessment of surgical treatment of femoral neck fractures
timeFrame: day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)
measure: Change in radiological outcome: assessment of surgical treatment of femoral neck fractures
timeFrame: day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Orthopaedics and Trauma Surgery (DOTS).
Study officials:
affiliation: Department of Orthopaedics and Trauma Surgery (DOTS).
name: Franziska Saxer, Dr. MD
role: PRINCIPAL_INVESTIGATOR
References: