NCT04062604

Brief Summary

The goal of this study is the evaluation of lower limb function and the quaility of life of the patients after femur fracture operation treatment. LLTQ (Lower-Limb Tasks Questionnaire), LEFS (Lower Extremity Funcional Scale), LLFI-10 (Lower Limb Functional Index - 10) and LLFI (Lower Limb Functional Index) will be used for all the patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 14, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

April 14, 2019

Last Update Submit

February 12, 2020

Conditions

Surgical Treatment

Outcome Measures

Primary Outcomes (2)

  • Subjective assessment of the lower limb function

    Questionnaire, score scale - according to the description in questionnaire, lower score- worse outcome

    12 month

  • Objective assessment of the lower limb function

    Physical exam

    12 month

Secondary Outcomes (2)

  • Subjective assessment of the lower limb function

    3, 6, 24 months

  • Objective assessment of the lower limb function

    3, 6, 24 months

Study Arms (4)

Femur fracture

Stabilization of femur fracture according to the AO fundation guidelines

Other: surgery

Hip alloplasty

Endoprothesis

Other: surgery

Knee alloplasty

Endoprothesis

Other: surgery

Knee arthroscopy

Resection of the meniscus lesion or anterior cruciatus ligamentum reconstruction

Other: surgery

Interventions

surgeryOTHER

surgical treatment of femur fracture, hip and knee alloplasty, knee arthroscopy

Femur fractureHip alloplastyKnee alloplastyKnee arthroscopy

Eligibility Criteria

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

All patients planned for the surgical interventions

You may qualify if:

  • Signed Patient Informed Consent
  • Patients planned for the surgical treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jagiellonian University

Krakow, Poland

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • Marcin Bednarek

    Jagiellonian University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcin Bednarek

CONTACT

+486030674912marcin.bednarek@uj.edu.pl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 14, 2019

First Posted

August 20, 2019

Study Start

September 1, 2019

Primary Completion

September 1, 2020

Study Completion

September 1, 2022

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

PL(1)