NCT06491420

Brief Summary

Femoral head fractures, often caused by high-energy trauma, pose significant challenges due to complications like avascular necrosis, post-traumatic osteoarthritis, and sciatic nerve damage. While traditionally treated with open reduction and internal fixation (ORIF) or total hip replacement (THR), hip arthroscopy has emerged as a minimally invasive alternative that reduces surgical trauma, offers direct fracture visualization and manipulation, and may result in shorter recovery times and fewer complications.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

2.6 years

First QC Date

July 1, 2024

Last Update Submit

July 1, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Non Arthritic Hip Score

    The Following five questions concern the amount of pain: 1 Walking on a flat surface? 2 Going up or down stairs? 3 At night while in bed? 4 Sitting or lying? 5 tanding upright? the scoring for each question is from 0 to 4

    6 months

Study Arms (1)

Patients with pipin 1 fractures fixed with arthroscopy

EXPERIMENTAL

Accurate portal placement was essential for optimal visualization and safe access to the hip joint. * The anterolateral, anterior, and distal lateral accessory portals were utilized for arthroscopic labral repair. * The anterolateral portal was placed approximately 1-2 cm superior to the tip of the greater trochanter and 1-2 cm anterior, at an angle of 15° to 20° relative to the floor. * The anterior portal was established for visualization of the posterior-superior capsule, posterior-superior labrum, posterior recess, femoral head, ligamentum teres, and other structures. * The distal lateral accessory portal was placed after traction was released and the operative knee was flexed to 45°. After reducing the fracture under arthroscopic guidance, a guidewire fixed the fracture a cannulated screw was passed over the wire to fix the fracture.

Other: fixation with arthroscopy

Interventions

the pipkin fracture is fixed with the help of arthroscopy and percutaneous methods.

Patients with pipin 1 fractures fixed with arthroscopy

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with pipkin 1 fractures

You may not qualify if:

  • any associated pelvic fractures
  • severe medical conditions that prevent the patient from undergoing surgery
  • delayed presentation after 2 weeks from initial fracture date

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Al Ainy-Cairo University- Faculty of Medicine

Cairo, Manial, 11956, Egypt

RECRUITING

MeSH Terms

Interventions

Arthroscopy

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeOrthopedic Procedures

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A single limb interventional study where all cases presenting with pipkin 1 fractures are treated with arthroscopy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 9, 2024

Study Start

January 1, 2022

Primary Completion

August 1, 2024

Study Completion

December 1, 2024

Last Updated

July 9, 2024

Record last verified: 2024-07

Locations