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

Proximal Femoral Fracture Clinical Trial

— ProFi  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03768622
• Other study ID #: 2018-00933; ch18Saxer2
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: March 6, 2021

Study information

• Verified date: November 2021
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2906
• Est. completion date: March 6, 2021
• Est. primary completion date: March 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Proximal Femoral Fracture

Intervention

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
• surgery for femoral neck fracture
surgical treatment for proximal femoral fracture with a partial hip arthroplasty in case of femoral neck fractures

Locations

Country	Name	City	State
Switzerland	Department of Orthopaedics and Trauma Surgery (DOTS).	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient clinical outcome	Quantification of Rehospitalizations	from date of surgery until 1 year follow up period after surgery
Primary	Change in Patient clinical outcome	Change in living situation	at 1 year follow up date after surgery
Primary	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)
Primary	Change in Patient clinical outcome	Quantification of Reoperations	from date of surgery until 1 year follow up period after surgery
Primary	Change in Patient clinical outcome	Quantification of infections	from date of surgery until 1 year follow up period after surgery
Primary	Change in Patient clinical outcome	Quantification of deaths and date of death	from date of surgery until 1 year follow up period after surgery
Primary	Change in Patient clinical outcome	Change in use of walking aids	at 1 year follow up date after surgery
Primary	Change in Patient clinical outcome	Change in pain at rest (yes/no),	at 1 year follow up date after surgery
Primary	Change in Patient clinical outcome	Change in pain under stress (yes/no)	at 1 year follow up date after surgery
Primary	Change in Patient clinical outcome	Change in restrictions in daily living (yes/no),	at 1 year follow up date after surgery
Primary	Change in Patient clinical outcome	Change in use of analgetics (yes/no)	at 1 year follow up date after surgery
Primary	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)
Primary	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)
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)