NCT03875014

Brief Summary

This study is conducted with the aim to compare the functional outcome, rate of dislocation, complications and mortality after treatment of displaced neck of femur fracture with bipolar hemiarthroplasty or total hip arthroplasty with dual mobility cuff.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

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

January 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

3 years

First QC Date

March 13, 2019

Last Update Submit

March 14, 2019

Conditions

Dislocations

Keywords

dual mobility cuptotal hip repcamentbipolar hemiarthroplastydislocation

Outcome Measures

Primary Outcomes (1)

  • mortality

    death within one year of index surgery

    one year

Secondary Outcomes (1)

  • functional outcome

    one year

Study Arms (2)

group 1

Bipolar hemiarthroplasty grop

Device: surgery with implant for hip fracture

group 2

Total hip replacement dual mobility group

Device: surgery with implant for hip fracture

Interventions

surgery with implant for hip fractureDEVICE

hip replacement with bipolar hemiarthroplasty or total hip arthroplasty dual mobility done and patients was followed

group 1group 2

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

. Patients of age group more than 60 years old with hip fracture treated via bipolar hemiarthroplasty or total hip replacement with dual mobility cup

You may qualify if:

  • Patients of age group more than 60 year who underwent hip arthroplasty (bipolar hemiarthroplasty or THA with dual mobility implant) between 2015 and 2017 for displaced neck of femur fracture with a complete follow up for one year

You may not qualify if:

  • Patient who underwent hip arthroplasty for other indications, patients younger than 60 years patient with pathological fractures, patient with missing records and patients lost to follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Joint Dislocations

Interventions

Surgical Procedures, OperativeMutagenesis, Insertional

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

Protein EngineeringGenetic EngineeringGenetic TechniquesInvestigative TechniquesMutationGenetic VariationGenetic PhenomenaMutagenesis

Study Design

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

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 14, 2019

Study Start

January 1, 2015

Primary Completion

December 31, 2017

Study Completion

December 31, 2018

Last Updated

March 15, 2019

Record last verified: 2019-03