Results of the Staged Surgical Approach for Management of Infected Un-united Femoral Shaft Fractures in Adults

December 20, 2020 updated by: Michael Girgis Waheeb Tawfeek, Assiut University
Assessment of the efficacy of the multistage technique in the eradication of infection and achieving the union of traumatic infected femoral un-united shaft fractures in adult patients for one year follow up.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

All cases will be treated by the induced membrane technique in two stages. In the first stage, thorough debridement of the infected bone and soft tissues and copious lavage will be done.

After radical debridement, primary fixation will be done by either external fixation or antibiotic cement coated internally fixed implants.If there is a bone defect, it will be measured and filled with an antibiotic-impregnated (PMMA) cement spacer. The second stage procedure will be performed 4 to 8 weeks after the first one if soft tissue permits and only if there is no clinical or biochemical evidence of ongoing infection as indicated by normal white blood cell count, C-reactive protein, and erythrocyte sedimentation rate. It includes the exchange of the antibiotic cement spacer by a cancellous bone graft.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

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

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

adult patient attending the department of orthopedics and traumatology, Assiut university with traumatic infected un-united femoral fractures.

Description

Inclusion Criteria:

  1. Age between 18 and 65 years old.
  2. Type 32 according to Arbeitsgemeinschaft für Osteosynthesefragen classification in adults.

Exclusion Criteria:

  1. Patients with deficient soft tissue coverage with exposed bone.
  2. Patients with reflex sympathetic dystrophy.
  3. Spinal injuries associated with neurological complications affecting the lower limbs.
  4. Associated head injury affecting the conscious level or the motor power of the injured limb.
  5. Associated mutilating limb injury or peripheral amputation.
  6. Bone defect more than 6 cm in length.
  7. Chronic peripheral ischemia of the limb.
  8. Past history of pathological fractures.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the patient-reported clinical outcome as assessed using the WOMAC Osteoarthritis Index from enrollment to 1-year follow-up after the definitive stage.
Time Frame: from enrollment to one year follow up after the definitive stage.
WOMAC is composed of 24 items over 3 subscales (5 for pain, 2 for stiffness, and 17 for physical function). Participants can rate their difficulty for each item.
from enrollment to one year follow up after the definitive stage.

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Michael G. Waheeb, Msc ortho, Assiut University , 71515 Assiut, Arab Republic of Egypt.
  • Study Chair: Osama Farouk, MD ortho, Assiut University , 71515 Assiut, Arab Republic of Egypt.
  • Study Director: Hossam MA Abubeih, MD ortho, Assiut University , 71515 Assiut, Arab Republic of Egypt.
  • Study Director: Mahmoud Badran, MD ortho, Assiut University , 71515 Assiut, Arab Republic of Egypt.

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 (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

December 11, 2020

First Submitted That Met QC Criteria

December 20, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Actual)

December 23, 2020

Last Update Submitted That Met QC Criteria

December 20, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fracture-related infection

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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