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

• Conditions: Fracture Non Union

• Registration Number: NCT04681846
• Lead Sponsor: Assiut University

Brief Summary

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

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 Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-20
• Last Update Submitted: 2020-12-20
• Study First Posted: 2020-12-23
• Last Update Posted: 2020-12-23
• Study Start: 2021-03
• Primary Completion: 2022-08
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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.