Hardware Preservation in Management of Infected Non United or Delayed United Fractures of Long or Short Bones by Debridement and Local Calcium Sulfate Loaded by Antibiotics

Study Overview
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Brief Summary
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Diagnosis of infection based on elevated serum markers of infection (ESR, CRP), discharging sinus, preoperative radiographs suggestive of bone infection and radiological findings . [6] infected nonunion mean the bone has previous fracture , the bone not healed may be one of the reasons it didn't heal because there is sub-acute infection , there is low grade colonization into the bone or around the wound preventing the bone from healing , it different from infected fracture which occur fairly acutely. [6, 7] Infected nonunion treated with systemic antibiotics alone, without using local antibiotic delivery systems associated with higher recurrence and reoperation rates. [7] This led to the development and use of medical-grade calcium sulfate (CS), CS facilitates osseous healing in an osteoconductive fashion by filling the bone void and preventing fibrous tissue

Official Title
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Hardware Preservation in Management of Infected Non United or Delayed United Fractures of Long or Short Bones by Debridement and Local Calcium Sulfate Loaded by Antibiotics

Conditions
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Infected Non Union and Delayed Union in Fractures of Both Long and Short Bones

Intervention / Treatment
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* Procedure: local debridement and local calcium sulfate loaded by antibiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient at any age and of any sex with infected non united fracture of long or short bones Exclusion Criteria: Presence of previous vascular injury or pathological fracture Refusal to participate Inability to provide informed consent Allergy or sensitivity to vancomycin or tobramycin Patient with impaired renal function Patient with hypercalcemia
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: infected non united fractures<br>patient of any age and any sex with infected non united fractures of long or short bones | Procedure: local debridement and local calcium sulfate loaded by antibiotics<br>* debridement of infected non united fractures and placement of local calcium sulfate loaded by antibiotic then follow up at regular intervals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non union scoring system | Non-Union Scoring System (NUSS) aims to classify non-unions according to their severity and relate them to four treatment categories. | one year | 
| Karlström-Olerud physical function scale | Karlström-Olerud physical function scale is a scale to assess physical functional outcome postoperative. | one year |