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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Fracture Non Union

Intervention / Treatment
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* Procedure: Staged approach using antibiotic-cement impregnated PMMA spacer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 65 years old. Type 32 according to Arbeitsgemeinschaft für Osteosynthesefragen classification in adults. Exclusion Criteria: Patients with deficient soft tissue coverage with exposed bone. Patients with reflex sympathetic dystrophy. Spinal injuries associated with neurological complications affecting the lower limbs. Associated head injury affecting the conscious level or the motor power of the injured limb. Associated mutilating limb injury or peripheral amputation. Bone defect more than 6 cm in length. Chronic peripheral ischemia of the limb. Past history of pathological fractures.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Staged approach using antibiotic-cement impregnated PMMA spacer|It will be prepared in the following manner. the cement will be mixed with vancomycin in a ratio of 2 gm to each 40 gm of the spacer. The spacer should be shaped into a cylinder before its solidification. The spacer should be as big as possible to fill the whole defect, without compromising the soft tissue and skin closure. Also, cement should wrap the two ends of bone extremities on 2 or 3 centimeters.|

What is the study measuring?
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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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infected non-union