Infected Non Union and Delayed Union in Fractures of Both Long and Short BonesNCT05231148
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
A study testing local debridement and local calcium sulfate loaded by antibiotics in people with Infected Non Union and Delayed Union in Fractures of Both Long and Short Bones, run by Sohag University at 1 site in Egypt.
Trial summary
Diagnosis of infection based on elevated serum markers of infection (ESR, CRP), discharging sinus, preoperative radiographs suggestive of bone infection and radiological findings . Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infected Non Union and Delayed Union in Fractures of Both Long and Short Bones
- What is being tested?
- local debridement and local calcium sulfate loaded by antibiotics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Dec 2021to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient at any age and of any sex with infected non united fracture of long or short bones
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
abdelrahman h khalifa, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Osama R ElSherif, professor
About this study
- 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
- Being tested
- local debridement and local calcium sulfate loaded by antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local debridement and local calcium sulfate loaded by antibioticsProcedure or surgery
debridement of infected non united fractures and placement of local calcium sulfate loaded by antibiotic then follow up at regular intervals
| Study group | Role | What they receive |
|---|---|---|
| infected non united fractures | Other | patient of any age and any sex with infected non united fractures of long or short bones Receives: Procedure: local debridement and local calcium sulfate loaded by antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Karlström-Olerud physical function scale
Karlström-Olerud physical function scale is a scale to assess physical functional outcome postoperative.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start12 Dec 2021
- Primary completionJun 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infected Non Union and Delayed Union in Fractures of Both Long and Short BonesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelraheem Mohamed Sonbol, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231148
- Sponsor's protocol ID
- soh-med-22-01-01
- Status last verified
- Mar 2023
- First submitted
- 12 Jan 2022
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 29263731Drosos 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.
PubMed 23109071Laycock 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.
PubMed 30428581
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05231148
- Acronym / sponsor ID
- soh-med-22-01-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 12 Dec 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| infected non united fractures | Other | Procedure: local debridement and local calcium sulfate loaded by antibioticspatient of any age and any sex with infected non united fractures of long or short bones |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient at any age and of any sex with infected non united fracture of long or short bones
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| local debridement and local calcium sulfate loaded by antibioticsdebridement of infected non united fractures and placement of local calcium sulfate loaded by antibiotic then follow up at regular intervals | Procedure or surgery | infected non united fractures |
Primary outcome
Non union scoring system
Time frame: 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
Time frame: one year
Karlström-Olerud physical function scale is a scale to assess physical functional outcome postoperative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Background: PubMed 29263731Calori 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.
- Background: PubMed 23109071Drosos 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.
- Background: PubMed 30428581Laycock 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.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
abdelrahman h khalifa, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local debridement and local calcium sulfate loaded by antibiotics in people with Infected Non Union and Delayed Union in Fractures of Both Long and Short Bones, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdelraheem m sonbol, resident (01121280438, abdelreheem011115@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non union scoring system (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05231148, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.