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

Not Applicable

Recruiting

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

• Registration Number: NCT05231148
• Lead Sponsor: Sohag University

Brief Summary

* 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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-12
• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-28
• Study First Posted: 2022-02-09
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23
• Primary Completion: 2023-06
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt