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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

Primary Purpose

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

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

local debridement and local calcium sulfate loaded by antibiotics

About this trial

This is an interventional treatment trial for Infected Non Union and Delayed Union in Fractures of Both Long and Short Bones

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Sohag University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

infected non united fractures

Arm Description

patient of any age and any sex with infected non united fractures of long or short bones

Outcomes

Primary Outcome Measures

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.

Karlström-Olerud physical function scale

Karlström-Olerud physical function scale is a scale to assess physical functional outcome postoperative.

Secondary Outcome Measures

Full Information

NCT ID

NCT05231148

First Posted

January 12, 2022

Last Updated

March 21, 2023

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT05231148

Brief Title

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

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 12, 2021 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

infected non united fractures

Arm Type

Other

Arm Description

patient of any age and any sex with infected non united fractures of long or short bones

Intervention Type

Procedure

Intervention Name(s)

local debridement and local calcium sulfate loaded by antibiotics

Intervention Description

debridement of infected non united fractures and placement of local calcium sulfate loaded by antibiotic then follow up at regular intervals

Primary Outcome Measure Information:

Title

Non union scoring system

Description

Non-Union Scoring System (NUSS) aims to classify non-unions according to their severity and relate them to four treatment categories.

Time Frame

one year

Title

Karlström-Olerud physical function scale

Description

Karlström-Olerud physical function scale is a scale to assess physical functional outcome postoperative.

Time Frame

one year

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Abdelraheem m sonbol, resident

Phone

01121280438

abdelreheem011115@med.sohag.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

abdelrahman h khalifa, professor

Phone

01003701283

Facility Information:

Facility Name

Sohag University Hospital

City

Sohag

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Osama R ElSherif, professor

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

29263731

Citation

Calori GM, Mazza EL, Mazzola S, Colombo A, Giardina F, Romano F, Colombo M. Non-unions. Clin Cases Miner Bone Metab. 2017 May-Aug;14(2):186-188. doi: 10.11138/ccmbm/2017.14.1.186. Epub 2017 Oct 25.

Results Reference

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PubMed Identifier

23109071

Citation

Drosos GI, Ververidis A, Babourda EC, Kakagia D, Verettas DA. Calcium sulfate cement in contained traumatic metaphyseal bone defects. Surg Technol Int. 2012 Dec;22:313-9.

Results Reference

background

PubMed Identifier

30428581

Citation

Laycock PA, Cooper JJ, Howlin RP, Delury C, Aiken S, Stoodley P. In Vitro Efficacy of Antibiotics Released from Calcium Sulfate Bone Void Filler Beads. Materials (Basel). 2018 Nov 13;11(11):2265. doi: 10.3390/ma11112265.

Results Reference

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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

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