NCT06403124

Brief Summary

Background: Historically, acetabular fractures were treated conservatively which leading to long lasting morbidity like severe pain, limitation of movement and osteoarthritis. Now, evidence suggest surgery for all acetabular fractures for better outcome. Objectives: To evaluate the clinical and functional outcomes of open reduction and internal fixation of posterior wall of acetabulum fractures. Methods: This prospective clinical trial was conducted at Chittagong Medical College hospital, Chattogram, from January 2022 to February 2024. Sample size was 32 with fractures as per set criteria and was treated surgically. The outcome variables were functional (according to modified Merle D'Aubigne and Postel score) and radiological (according to Matta's grading). Evaluation was done at 6th weeks and at 03rd, 06th, 09th months. Detailed history, clinical examination, investigations, operative details, post-operative outcome and other parameters were documented. Data were collected in data collection form and were analyzed at the end of the study by using SPSS-25. P-value was considered as statistically significant when it was less than 0.05 and confidence interval was set at 95% level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 7, 2024

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

April 26, 2024

Last Update Submit

May 6, 2024

Conditions

Keywords

Posterior wall of acetabulum, operative management

Outcome Measures

Primary Outcomes (1)

  • Functional outcome

    Functional outcome by Modified Merle d'Aubigne-Postel Score, Highest score - 18, that means excellent outcome and lowest score - 03, that means poor outcome.

    09 months

Study Arms (1)

Patients with posterior wall of acetabulum fracture

EXPERIMENTAL
Procedure: Open reduction and internal fixation

Interventions

Open reduction and internal fixation by reconstruction plate and screws

Patients with posterior wall of acetabulum fracture

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Posterior wall fracture with unstable hip joint
  • Posterior wall fracture with posterior column or transverse fracture
  • incarcerated osteochondral fragment
  • Age more than 18 years and less than 60 years
  • injury within 03 weeks.

You may not qualify if:

  • open fracture
  • associated other acetabular fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chittagong Medical College

Chittagong, 4203, Bangladesh

Location

MeSH Terms

Interventions

Open Fracture ReductionFracture Fixation, Internal

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical officer

Study Record Dates

First Submitted

April 26, 2024

First Posted

May 7, 2024

Study Start

March 1, 2022

Primary Completion

February 29, 2024

Study Completion

February 29, 2024

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

Locations