- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06403124
Outcome of Operative Management of Posterior Wall of Acetabulum Fracture
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Chittagong, Bangladesh, 4203
- Chittagong Medical College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- open fracture
- associated other acetabular fracture
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients with posterior wall of acetabulum fracture
|
Open reduction and internal fixation by reconstruction plate and screws
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional outcome
Time Frame: 09 months
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 59.27.00.013.19.PG.09.2023/992
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Posterior Wall of Acetabulum Fracture
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University of CincinnatiFoundation for Orthopedic TraumaCompletedFracture of Posterior Wall of AcetabulumUnited States
-
Hebei Medical University Third HospitalUnknownFracture of Posterior Wall of AcetabulumChina
-
Peifu TangCompletedFracture of AcetabulumChina
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Fondation Hôpital Saint-JosephCompletedTransverse Fracture of AcetabulumFrance
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Groupe Hospitalier Paris Saint JosephCompleted
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Zimmer BiometCompletedAcetabulum Fracture | Pelvic Ring FractureItaly
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Bakirkoy Dr. Sadi Konuk Research and Training HospitalCompleted
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University of Missouri-ColumbiaCompletedAcetabulum FracturesUnited States
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MetroHealth Medical CenterCompletedFemur Fracture | Unstable Pelvic Ring Fracture | Unstable Acetabulum FractureUnited States
Clinical Trials on Open reduction and internal fixation
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University of Maryland, BaltimoreCompletedAcetabular FractureUnited States
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UMAE Hospital de Traumatologia y Ortopedia de PueblaCompletedClosed Fracture of Shaft of Clavicle
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Spectrum Health HospitalsWithdrawnAnkle FracturesUnited States
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JointResearchAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Maasstad... and other collaboratorsCompletedRadius Distal FractureNetherlands
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Shenyang Medical CollegeUnknown
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King Edward Medical UniversityCompletedMandibular Fractures
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Aya Ayman AhmedNot yet recruiting
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Kasr El Aini HospitalRecruitingA Comparative Study Between Positional and Lag Screws for the Fixation of Medial Malleolar FracturesAnkle Fractures | Medial Malleolus FractureEgypt
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Taipei Medical University Shuang Ho HospitalNot yet recruiting
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Kasr El Aini HospitalCompleted