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

A

Assiut University

Status

Unknown

Conditions

Fracture Non Union

Treatments

Procedure: Staged approach using antibiotic-cement impregnated PMMA spacer

Study type

Observational

Funder types

Other

Identifiers

NCT04681846
Fracture-related infection

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

0

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Central trial contact

Michael G. Waheeb, Msc ortho

Data sourced from clinicaltrials.gov

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