NCT06872970

Brief Summary

Outcomes of open reduction and internal fixation of femoral neck fractures using dynamic hip screw versus cannulated screws combined with medial buttress plate.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Progress71%
Apr 2024Mar 2027

Study Start

First participant enrolled

April 12, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 12, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2027

Last Updated

March 12, 2025

Status Verified

April 1, 2024

Enrollment Period

2.4 years

First QC Date

February 16, 2025

Last Update Submit

March 10, 2025

Conditions

Keywords

Open reduction

Outcome Measures

Primary Outcomes (1)

  • Harris hip score

    Using harris hip score evaluate to evaluate post operative: 1. pain 2. amount and type of support 3. limp 4. distance walked 5. shoes and socks 6. sitting 7. climbing stairs

    3 years

Study Arms (2)

Open reduction of femoral neck fractures in healthy adults

EXPERIMENTAL

Open reduction of femoral neck fractures in healthy adults between 16 years and 60 years old using cannulated screws and medial buttress plate through watson jones or smith peterson approach

Procedure: Open reduction of femoral neck fractures and internal fixation by dynamic hip screwsProcedure: Open reduction of femoral neck fractures using watson jones or smith peterson approachand internal fixation by cannulated screws and medial buttress plate

Open reduction of femoral neck fractures

EXPERIMENTAL

Open reduction and internal fixation of femoral neck fracture in healthy adults between 16 years and 60 years old using dynamic hip screw through watson jones or smith peterson approach

Procedure: Open reduction of femoral neck fractures and internal fixation by dynamic hip screwsProcedure: Open reduction of femoral neck fractures using watson jones or smith peterson approachand internal fixation by cannulated screws and medial buttress plate

Interventions

Open reduction of femoral neck using watson jones or smith peterson approach fractures then fixation of fractures by dynamic hip screws

Open reduction of femoral neck fracturesOpen reduction of femoral neck fractures in healthy adults

Open reduction of femoral neck fractures then fixation of fractures by cannulated screws and medial buttress plate

Open reduction of femoral neck fracturesOpen reduction of femoral neck fractures in healthy adults

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients of both genders between the ages of 16 to 60 years old and had trauma caused femoral neck fracture.
  • patients of both genders with Garden's type three and four femoral neck fractures

You may not qualify if:

  • patients of both genders below the age of 16 and above 60 years old.
  • patients with pathological femoral neck fractures.
  • patients with autoimmune diseases like rheumatoid arthritis.
  • patients with neglected femoral neck fractures(more than 1 week).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit university

Asyut, Egypt, Egypt

Location

Related Publications (1)

  • Keshet D, Bernstein M. Open Reduction Internal Fixation of Femoral Neck Fracture-Anterior Approach. J Orthop Trauma. 2020 Aug;34 Suppl 2:S27-S28. doi: 10.1097/BOT.0000000000001818.

    PMID: 32639347BACKGROUND

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Using watson-jones or smith-peterson approach in open reduction of femoral neck fractures then fixation of fractures by dynamic hip screws vs cannulated screws and medial butteess plate
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

February 16, 2025

First Posted

March 12, 2025

Study Start

April 12, 2024

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

March 30, 2027

Last Updated

March 12, 2025

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations