Clinical trial NCT04681846: Results of the Staged Surgical Approach for Management of Infected Un-united Femoral Shaft Fractures in Adults
Official title: Results of the Staged Surgical Approach for Management of Infected Un-united Femoral Shaft Fractures in Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fracture Non Union
Keywords: infected non-union
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patient attending the department of orthopedics and traumatology, Assiut university with traumatic infected un-united femoral fractures.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: from enrollment to one year follow up after the definitive stage.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University , 71515 Assiut, Arab Republic of Egypt.
name: Michael G. Waheeb, Msc ortho
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University , 71515 Assiut, Arab Republic of Egypt.
name: Osama Farouk, MD ortho
role: STUDY_CHAIR
affiliation: Assiut University , 71515 Assiut, Arab Republic of Egypt.
name: Hossam MA Abubeih, MD ortho
role: STUDY_DIRECTOR
affiliation: Assiut University , 71515 Assiut, Arab Republic of Egypt.
name: Mahmoud Badran, MD ortho
role: STUDY_DIRECTOR
References:
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