Use of Arthroscopy in Treatment of Acute Pediatric Septic Hip Infection

July 29, 2024 updated by: Hesham Mohamed Elbaseet

Arthroscopic Versus Open Management of Acute Pediatric Septic Hip Infection: A Randomized Controlled Trial

Acute septic hip infection in pediatric population is a true orthopedic surgical emergency that require early diagnosis and prompt management. Open surgical debridement and drainage of the hip through lateral approach is the gold standard method of treatment. Usage of hip arthroscopy in the treatment of such condition has been in clinical practice for more than 30 years. However, literature is still lacking in actual prospective comparison about the outcome of both methods.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will divide the children presented with acute septic hip infection into two groups; the control group in which the child will undergo traditional open surgical debridement and drainage of the hip via lateral approach, and the intervention group in which arthroscopic drainage and debridement of the hip will be done. The outcomes of both methods will be recorded and compared. The research hypothesis is that arthroscopic management of acute pediatric septic hip infection is as effective as open surgery; with fewer complications and faster recovery.

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 10 months - 14 years _unilateral or bilateral acute septic hip arthritis

Exclusion Criteria:

  • Children with pre-existing other pathology of the affected hip, whether he / she has surgery for management of this pathology or not.

    • Patients whose parents refuse to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control Group
The child in this group will be treated for his\ her acute septic hip infection using open surgery ( The Standard Method)
Procedure: Open debridement of acute pediatric septic hip
surgical drainage and debridement of acute septic hip in children via classic lateral approach
Other: Intervention Group
The child in this group will be treated for his\ her acute septic hip infection arthroscopically
Procedure: Arthroscopic management of acute pediatric septic hip infecion
Three-portals tractionless hip arthroscopy will be used to treat acute pediatric septic hip infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Mckay's criteria
Time Frame: One Year Follow-up

Excellent: painless, stable hip; no limp; more than 15 degrees of internal rotation.

Good: painless, stable hip; slight limb or decreased motion , negative Trendelenburg sign Fair: minimum pain; moderate stiffness, positive Trendelenburg sign Poor: significant pain.
One Year Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hesham Mohamed Elbaseet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 13, 2024

Primary Completion (Estimated)

February 12, 2026

Study Completion (Estimated)

February 12, 2027

Study Registration Dates

First Submitted

July 11, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ٍSeptic Hip in childern

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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