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

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ClinicalTrials.gov Identifier: NCT03768622
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.


Condition or disease Intervention/treatment
Proximal Femoral Fracture Procedure: surgery for pertrochanteric femoral fracture Procedure: surgery for femoral neck fracture

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Proximal Femoral Fractures - Patient Population, Risk Factors, Surgical Performance and Outcome
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in Patient clinical outcome [ Time Frame: from date of surgery until 1 year follow up period after surgery ]
    Quantification of Rehospitalizations

  2. Change in Patient clinical outcome [ Time Frame: at 1 year follow up date after surgery ]
    Change in living situation

  3. 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

  4. Change in Patient clinical outcome [ Time Frame: from date of surgery until 1 year follow up period after surgery ]
    Quantification of Reoperations

  5. Change in Patient clinical outcome [ Time Frame: from date of surgery until 1 year follow up period after surgery ]
    Quantification of infections

  6. 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

  7. Change in Patient clinical outcome [ Time Frame: at 1 year follow up date after surgery ]
    Change in use of walking aids

  8. Change in Patient clinical outcome [ Time Frame: at 1 year follow up date after surgery ]
    Change in pain at rest (yes/no),

  9. Change in Patient clinical outcome [ Time Frame: at 1 year follow up date after surgery ]
    Change in pain under stress (yes/no)

  10. Change in Patient clinical outcome [ Time Frame: at 1 year follow up date after surgery ]
    Change in restrictions in daily living (yes/no),

  11. Change in Patient clinical outcome [ Time Frame: at 1 year follow up date after surgery ]
    Change in use of analgetics (yes/no)

  12. 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

  13. 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)

  14. 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


Secondary Outcome Measures :
  1. Change in patient clinical outcome (according Penrod score) [ Time Frame: preoperatively and at 1 year follow up date after surgery ]
    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)

  2. 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) ]
    central positioning and insertion of the neck screw

  3. radiological outcome: assessment of surgical treatment of femoral neck fractures [ Time Frame: 1year postoperative (if n.a. min 6 months postoperative) ]

    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

  4. Change in subsidence (radiological outcome: assessment of surgical treatment of femoral neck fractures) [ Time Frame: 1year postoperative (if n.a. min 6 months postoperative) ]
    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

  5. radiological outcome: assessment of surgical treatment of femoral neck fractures [ Time Frame: 1year postoperative (if n.a. min 6 months postoperative) ]
    cortical atrophy i.e. longitudinal intracortical porosis with a consecutive thinning of the cortex without measurable thickening of the femur (yes-no-n.a.)

  6. radiological outcome: assessment of surgical treatment of femoral neck fractures [ Time Frame: 1year postoperative (if n.a. min 6 months postoperative) ]
    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

  7. radiological outcome: assessment of surgical treatment of femoral neck fractures [ Time Frame: 1year postoperative (if n.a. min 6 months postoperative) ]
    debonding i.e. radiolucent line at the prosthesis-cement interface not visible on the first postoperative radiograph (yes-no-n.a.)

  8. 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) ]
    leg-length discrepancy (tangent to inferior pubic rami and tip of greater trochanter, if n.a. insertion of lesser trochanter)

  9. 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) ]
    leg-length discrepancy in mm (tangent to inferior pubic rami and tip of greater trochanter, if n.a. insertion of lesser trochanter)

  10. 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) ]
    alignment on ap view (central axis of the distal stem to bisecting axis of medullary canal at the isthmus) in °



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768622


Contacts
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Contact: Franziska Saxer, Dr. MD +41 61 265 25 25 franziska.saxer@usb.ch
Contact: Marcel Jakob, Prof. Dr. MD +41 61 265 25 25 marcel.jakob@usb.ch

Locations
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Switzerland
Department of Orthopaedics and Trauma Surgery (DOTS). Recruiting
Basel, Switzerland, 4031
Contact: Franziska Saxer, Dr. med    +41 061 328 62 43    Franziska.saxer@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Franziska Saxer, Dr. MD Department of Orthopaedics and Trauma Surgery (DOTS).

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03768622     History of Changes
Other Study ID Numbers: 2018-00933; ch18Saxer2
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Basel, Switzerland:
femoral neck fracture
pertrochanteric femoral fracture
risk factor for proximal femoral fracture

Additional relevant MeSH terms:
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Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries