Anterior Cruciate Ligament InjuriesNCT04100837
Multiple Instrumentation for ACL Reconstruction Regarding Bacterial Contamination
An observational study of Anterior Cruciate Ligament Injuries, run by Assiut University at 1 site in Egypt.
Trial summary
To determine the Effect of multiple instrumentation regarding bacterial contamination in transportal and transtibial techniques in ACL reconstruction .A Randomized controlled study Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2020to 30 Mar 2022
- How long will I take part?
- 3 Days
- Phase
- Observational
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Total coverage of all eligible cases will be admitted to Arthoscopic Unit within 6 months
Who may be able to join
- Isolated ACL Injury.
- Non deformed knee.
Who cannot join
- Associated knee injury (eg. PCL).
- Deformed knee ( eg. genu varus , genu valgus more than 4 degree )
- patient with medical history of being immune compromized patient eg,DM
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Multiple Instrumentation in Transportal and Transtibial Techniques for ACL Reconstruction Regarding Bacterial Contamination: A Randomized Control Study
To determine the Effect of multiple instrumentation regarding bacterial contamination in transportal and transtibial techniques in ACL reconstruction .A Randomized controlled study
Read the detailed description
Infection is a catastrophic and one of the most dreaded complications in orthopaedic surgery. Several measures have been undertaken to reduce the risk of infection, one of which is the use of systemic prophylactic antibiotics.
The purpose of this study is to determine the effect of multiple instrumentation regarding bacterial contamination in transportal and transtibial techniques in ACL reconstruction . About Eighty consecutive patients having surgical indication for ACL-R will be included, the cases will be divided into two groups, 35 cases will undergo for the transtibial technique and the other 45 cases will undergo for the transportal technique. After preparation, swabs will be obtained from subcutaneous tissue at antromedial portal track in transportal technique (femoral tunnel drilling) and in transtibial technique before and after the instrumentation and femoral screw insertion, a control sample will be taken at antrolateral track in both techniques, then samples will be sended to the lab to be studied.
- Conditions
- Anterior Cruciate Ligament Injuries
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| transportal group | swabs will be obtained from subcutaneous tissue at antromedial portal track in transportal technique (femoral tunnel drilling) , before and after the instrumentation and femoral screw insertion, a control sample will be taken at antrolateral track in both techniques, then samples will be sended to the lab to be studied. | |
| transtibial group | swabs will be obtained from subcutaneous tissue at antromedial portal track in transtibial technique (femoral tunnel drilling), before and after the instrumentation and femoral screw insertion, a control sample will be taken at antrolateral track in both techniques, then samples will be sended to the lab to be studied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment the concentration of contamination in ACL operation.
Effect of instrumentation on contamination of the operation,swabs will be obtained intraoperative for cultures.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start15 Jan 2020
- Primary completion30 Sep 2021
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerollos Zaghloul Thabet, Assiut University
- Investigators
- Hesham HK El-kadi, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100837
- Sponsor's protocol ID
- contamination of ACL surgery
- Status last verified
- Jul 2022
- First submitted
- 14 Sep 2019
- Last updated
- 13 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barnstable CJ, Jones EA, Bodmer WF, Bodmer JG, Arce-Gomez B, Snary D, Crumpton MJ. Genetics and serology of HL-A-linked human Ia antigens. Cold Spring Harb Symp Quant Biol. 1977;41 Pt 2:443-55. doi: 10.1101/sqb.1977.041.01.052. No abstract available.
PubMed 70300
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multiple Instrumentation in Transportal and Transtibial Techniques for ACL Reconstruction Regarding Bacterial Contamination: A Randomized Control Study
- ClinicalTrials.gov ID
- NCT04100837
- Acronym / sponsor ID
- contamination of ACL surgery
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 24 Sep 2019 (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.
To determine the Effect of multiple instrumentation regarding bacterial contamination in transportal and transtibial techniques in ACL reconstruction .A Randomized controlled study
Detailed description
Infection is a catastrophic and one of the most dreaded complications in orthopaedic surgery. Several measures have been undertaken to reduce the risk of infection, one of which is the use of systemic prophylactic antibiotics.
The purpose of this study is to determine the effect of multiple instrumentation regarding bacterial contamination in transportal and transtibial techniques in ACL reconstruction . About Eighty consecutive patients having surgical indication for ACL-R will be included, the cases will be divided into two groups, 35 cases will undergo for the transtibial technique and the other 45 cases will undergo for the transportal technique. After preparation, swabs will be obtained from subcutaneous tissue at antromedial portal track in transportal technique (femoral tunnel drilling) and in transtibial technique before and after the instrumentation and femoral screw insertion, a control sample will be taken at antrolateral track in both techniques, then samples will be sended to the lab to be studied.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transportal group | – | –swabs will be obtained from subcutaneous tissue at antromedial portal track in transportal technique (femoral tunnel drilling) , before and after the instrumentation and femoral screw insertion, a control sample will be taken at antrolateral track in both techniques, then samples will be sended to the lab to be studied. |
| transtibial group | – | –swabs will be obtained from subcutaneous tissue at antromedial portal track in transtibial technique (femoral tunnel drilling), before and after the instrumentation and femoral screw insertion, a control sample will be taken at antrolateral track in both techniques, then samples will be sended to the lab to be studied. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Total coverage of all eligible cases will be admitted to Arthoscopic Unit within 6 months
Key inclusion criteria (2 listed)
- Isolated ACL Injury.
- Non deformed knee.
Key exclusion criteria (3 listed)
- Associated knee injury (eg. PCL).
- Deformed knee ( eg. genu varus , genu valgus more than 4 degree )
- patient with medical history of being immune compromized patient eg,DM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment the concentration of contamination in ACL operation.
Time frame: Through study completion, an average of 1 year.
Effect of instrumentation on contamination of the operation,swabs will be obtained intraoperative for cultures.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Background: PubMed 70300Barnstable CJ, Jones EA, Bodmer WF, Bodmer JG, Arce-Gomez B, Snary D, Crumpton MJ. Genetics and serology of HL-A-linked human Ia antigens. Cold Spring Harb Symp Quant Biol. 1977;41 Pt 2:443-55. doi: 10.1101/sqb.1977.041.01.052. No abstract available.
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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.
Hesham HK El-kadi, professor study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injuries, run by Assiut 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 13 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment the concentration of contamination in ACL operation. (time frame: Through study completion, an average of 1 year.). 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 NCT04100837, which also lists 1 linked publication.
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 13 Jul 2022; AzTrials last refreshed its copy on 30 Oct 2026.