NCT06357312

Brief Summary

Prospective, comparative, randomized, double-blind study to evaluate the outcomes of trochanteric nailing in unstable hip fractures with and without a distal interlocking screw.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

April 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

Same day

First QC Date

April 4, 2024

Last Update Submit

April 4, 2024

Conditions

Hip Fracture

Keywords

hipfractureintertrochantericelderlyscrew

Outcome Measures

Primary Outcomes (1)

  • Evaluation of functional status using the Barthel index

    Evaluation of functional status 12 months after hip surgery

    12 months

Secondary Outcomes (2)

  • Postoperative mechanical complications

    12 months

  • Parker mobility scale

    12 months

Study Arms (2)

Group with distal screw

EXPERIMENTAL

Patients who have been randomly selected for this procedure are included.

Device: hip trochanteric nail

Group without distal screw

EXPERIMENTAL

Patients who have been randomly selected for this procedure are included.

Device: hip trochanteric nail

Interventions

hip trochanteric nailDEVICE

hip trochanteric nail with and without distal interlocking screw

Group with distal screwGroup without distal screw

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient over 50 years old
  • With unstable intertrochanteric hip fracture
  • Operated in the first 48 hours after hospital admission

You may not qualify if:

  • Simultaneous associated fractures
  • Fractures with subtrochanteric line
  • Non-acute fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elda University Hospital

Elda, Valencia, 03600, Spain

RECRUITING

MeSH Terms

Conditions

Hip FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Femoral FracturesWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Carlos De la Pinta Zazo

    Elda University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

FRANCISCO ANTONIO MIRALLES MUÑOZ

CONTACT

651552115fr_miralles@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Blinding of the patient included in the study and the investigator evaluating the results
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, comparative, randomized and double-blind study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Orthopedic Surgery

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 10, 2024

Study Start

April 1, 2024

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations

ES(1)