NCT03768622

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,906

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2021

Completed
Last Updated

November 4, 2021

Status Verified

November 1, 2021

Enrollment Period

2.8 years

First QC Date

October 23, 2018

Last Update Submit

November 3, 2021

Conditions

Proximal Femoral Fracture

Keywords

femoral neck fracturepertrochanteric femoral fracturerisk factor for proximal femoral fracture

Outcome Measures

Primary Outcomes (14)

  • 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 Outcomes (10)

  • Change in patient clinical outcome (according Penrod score)

    preoperatively and at 1 year follow up date after surgery

  • Change in radiological outcome: assessment of surgical treatment of pertrochanteric fractures

    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

    1year postoperative (if n.a. min 6 months postoperative)

  • Change in subsidence (radiological outcome: assessment of surgical treatment of femoral neck fractures)

    1year postoperative (if n.a. min 6 months postoperative)

  • radiological outcome: assessment of surgical treatment of femoral neck fractures

    1year postoperative (if n.a. min 6 months postoperative)

  • +5 more secondary outcomes

Study Arms (2)

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

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

Interventions

surgery for pertrochanteric femoral fracturePROCEDURE

surgical treatment for proximal femoral fracture with intramedullary nail type Gamma® Nail or similar in case of pertrochanteric fractures

surgery for pertrochanteric femoral fractures
surgery for femoral neck fracturePROCEDURE

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

surgery for femoral neck fracture

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Clinical follow up at another institution
  • Documented dissent in study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedics and Trauma Surgery (DOTS).

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Proximal Femoral FracturesFemoral Neck Fractures

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Franziska Saxer, Dr. MD

    Department of Orthopaedics and Trauma Surgery (DOTS).

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2018

First Posted

December 7, 2018

Study Start

June 1, 2018

Primary Completion

March 6, 2021

Study Completion

March 6, 2021

Last Updated

November 4, 2021

Record last verified: 2021-11

Locations

CH(1)