NCT05677191

Brief Summary

Proximal femoral nail \[PFNA\] versus dual mobility arthroplasty in treatment of unstable trochanteric fractures

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2023

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

November 23, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

12 months

First QC Date

November 23, 2022

Last Update Submit

January 9, 2023

Conditions

Trochanteric Fractures

Outcome Measures

Primary Outcomes (2)

  • Hip score

    compare between hip score in first group of pfna versus hip score in second group of THA

    Through study completion, an average of 1 year"

  • Operation time

    compartive operative time between first group of pfna versus second group of THA

    During surgery

Study Arms (2)

proximal femoral nail

EXPERIMENTAL

20 patient with trochanteric fractures , unstable type will use proximal femoral nail

Device: Proximal Femoral Nail

Dual Mobility Arthroplasty

ACTIVE COMPARATOR

20 patient with trochanteric fractures , unstable type will use dual mobility arthroplasty

Combination Product: Dual Mobility Arthroplasty

Interventions

Proximal Femoral NailDEVICE

open reduction

Also known as: PFNA
proximal femoral nail
Dual Mobility ArthroplastyCOMBINATION_PRODUCT

Hip Arthroplasty Surgery

Also known as: THA
Dual Mobility Arthroplasty

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with trochanteric unstable fractures.
  • age 60 or above
  • recent fracture time within 2 weeks time period
  • trochanteric starting point in pfna
  • patients medical condition is stable

You may not qualify if:

  • stable trochanteric fractures
  • delayed or neglected fractures
  • unstable patients medical conditions
  • pirformis fossa starting point in pfna

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hip Fractures

Interventions

Tacrine

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

AminoacridinesAcridinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Marcos Ha Morris

CONTACT

1287076751marcos.hanna.morris@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 23, 2022

First Posted

January 10, 2023

Study Start

January 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

January 11, 2023

Record last verified: 2023-01