Anterior Cruciate Ligament ReconstructionNCT05569889
Custom Surgical Tray in ACLR Procedure
An observational study of Anterior Cruciate Ligament Reconstruction, run by University Hospital, Toulouse at 1 site in France.
Trial summary
In the Toulouse University Hospital, the Custom Surgical Tray (CST) were not referenced. The nurse had to prepare and open all the components of the procedure separately. This is a long and wasteful process. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Anterior Cruciate Ligament reconstruction (ACLR)
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2021to 12 Aug 2021
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All surgery of Anterior Cruciate Ligament reconstruction were study during the period between 15 february 2021 and 15 August 2021.
Who may be able to join
- 18 years old patients
- patient necessitating a Anterior Cruciate Ligament reconstruction
Who cannot join
- patient refusing to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Implementing of Custom Surgical Tray (CST) in Anterior Cruciate Ligament Reconstruction Procedure on Sustainable Development.
In the Toulouse University Hospital, the Custom Surgical Tray (CST) were not referenced. The nurse had to prepare and open all the components of the procedure separately. This is a long and wasteful process.
CST brings together all the single-use medical devices necessary for an intervention, including draping and dressing elements, in the same single packaging.
Read more
Following the new local call for tenders on draping kits, and with the aim of standardizing and rationalizing practices, the implementation of CST within the requesting blocks whose orthopedic and traumatology block has been validated.
The hypothesis is that the CST would save time on preparing the trolley and on opening single-use equipment in the room while limiting the amount of waste.
Read the detailed description
To determine the social impact, the study assess the quality of life at work by measuring the difference, after implementing CST, in time needed for preparation of the trolley before entering the OR, for opening the instruments necessary by the surgical and circulating certified perioperative nurse (CNOR) in the Operating Room (OR), and for sorting the waste derived from the instrument's packages between plastic and paper after the intervention. In addition, the study assessed the biomechanical risk factors related to musculoskeletal disorders by evaluating the number of movements made by the CNOR when opening the instruments and sorting the waste, with and without CST. Finally, the study evaluate CNOR and surgeon's satisfaction after the implementation of CST.
To determine the ecologic impact, the difference in the number and weight of waste due to packaging of the disposable instruments, with and without CST was evaluated.
To determine the economic impact, the difference in cost of the instruments used, with and without CST was evaluated.
The hypothesis is that the use of CST enhances Sustainable Development (SD) by maintaining social development and environment protection, despite a possible additional cost.
- Being tested
- Anterior Cruciate Ligament reconstruction (ACLR)
- Keywords
- Custom Surgical Tray, Sustainable Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Cruciate Ligament reconstruction (ACLR)Procedure or surgery
A comparison between the two groups were done regarding the three following stages: (a) the preparation time of the trolley, which is the time taken by the CNOR to recover from the reserves all the single-packed sterile instruments (SPSI) necessary for the intervention or to recover the CST (b) the opening time of the instruments by the circulating nurse who opens the packages and gives them to the surgical nurse while respecting the sterility of the items, and by the surgical nurse who prepares the table for the intervention, and (c) the sorting time of the waste between plastic and paper at the end of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| control group | The medical staff was using the traditional surgical draping kit and single-packed sterile instruments (SPSI) that have to be opened separately Receives: Procedure: Anterior Cruciate Ligament reconstruction (ACLR) | |
| experimental group | The medical staff was using only the single packed CST, and containing all the necessary single-use items like surgical blades, sutures, dressing, surgical drapes, syringes, compresses, surgical gloves, jerseys. Receives: Procedure: Anterior Cruciate Ligament reconstruction (ACLR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preparation time of the trolley
Compared the number of minutes to prepare the trolley between control and experimental group
Measured: 1 day
Opening time of the instruments
Compared the number of minutes to open all the instrument between control and experimental group
Measured: 1 day
Sorting time of the waste
Compared the number of minutes to sorting of the waste between control and experimental group
Measured: 1 day
Secondary outcomes (2)
weight of trash packages
Compared the weight in grams of trash packages between control and experimental group
Measured: 1 day
Number of TRASH packages
Compared the Number of trash packages between control and experimental group
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start15 Apr 2021
- Primary completion15 Apr 2021
- Study completion12 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne CAVAIGNAC, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569889
- Sponsor's protocol ID
- RnIPH 2021-104
- Status last verified
- Oct 2022
- First submitted
- 27 Sep 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Implementing of Custom Surgical Tray (CST) in Anterior Cruciate Ligament Reconstruction Procedure on Sustainable Development.
- ClinicalTrials.gov ID
- NCT05569889
- Acronym / sponsor ID
- RnIPH 2021-104
- Keywords
- Custom Surgical Tray, Sustainable Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 12 Aug 2021 (actual)
- First posted
- 6 Oct 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.
In the Toulouse University Hospital, the Custom Surgical Tray (CST) were not referenced. The nurse had to prepare and open all the components of the procedure separately. This is a long and wasteful process.
CST brings together all the single-use medical devices necessary for an intervention, including draping and dressing elements, in the same single packaging.
Following the new local call for tenders on draping kits, and with the aim of standardizing and rationalizing practices, the implementation of CST within the requesting blocks whose orthopedic and traumatology block has been validated.
The hypothesis is that the CST would save time on preparing the trolley and on opening single-use equipment in the room while limiting the amount of waste.
Detailed description
To determine the social impact, the study assess the quality of life at work by measuring the difference, after implementing CST, in time needed for preparation of the trolley before entering the OR, for opening the instruments necessary by the surgical and circulating certified perioperative nurse (CNOR) in the Operating Room (OR), and for sorting the waste derived from the instrument's packages between plastic and paper after the intervention. In addition, the study assessed the biomechanical risk factors related to musculoskeletal disorders by evaluating the number of movements made by the CNOR when opening the instruments and sorting the waste, with and without CST. Finally, the study evaluate CNOR and surgeon's satisfaction after the implementation of CST.
To determine the ecologic impact, the difference in the number and weight of waste due to packaging of the disposable instruments, with and without CST was evaluated.
To determine the economic impact, the difference in cost of the instruments used, with and without CST was evaluated.
The hypothesis is that the use of CST enhances Sustainable Development (SD) by maintaining social development and environment protection, despite a possible additional cost.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | Procedure: Anterior Cruciate Ligament reconstruction (ACLR)The medical staff was using the traditional surgical draping kit and single-packed sterile instruments (SPSI) that have to be opened separately |
| experimental group | – | Procedure: Anterior Cruciate Ligament reconstruction (ACLR)The medical staff was using only the single packed CST, and containing all the necessary single-use items like surgical blades, sutures, dressing, surgical drapes, syringes, compresses, surgical gloves, jerseys. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All surgery of Anterior Cruciate Ligament reconstruction were study during the period between 15 february 2021 and 15 August 2021.
Key inclusion criteria (2 listed)
- 18 years old patients
- patient necessitating a Anterior Cruciate Ligament reconstruction
Key exclusion criteria (1 listed)
- patient refusing to participate.
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 |
|---|---|---|
| Anterior Cruciate Ligament reconstruction (ACLR)A comparison between the two groups were done regarding the three following stages: (a) the preparation time of the trolley, which is the time taken by the CNOR to recover from the reserves all the single-packed sterile instruments (SPSI) necessary for the intervention or to recover the CST (b) the opening time of the instruments by the circulating nurse who opens the packages and gives them to the surgical nurse while respecting the sterility of the items, and by the surgical nurse who prepares the table for the intervention, and (c) the sorting time of the waste between plastic and paper at the end of the intervention. | Procedure or surgery | control group, experimental group |
Primary outcome
Preparation time of the trolley
Time frame: 1 day
Compared the number of minutes to prepare the trolley between control and experimental group
Opening time of the instruments
Time frame: 1 day
Compared the number of minutes to open all the instrument between control and experimental group
Sorting time of the waste
Time frame: 1 day
Compared the number of minutes to sorting of the waste between control and experimental group
2 secondary outcomes
weight of trash packages
Time frame: 1 day
Number of TRASH packages
Time frame: 1 day
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 10 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Etienne CAVAIGNAC principal investigator
University Hospital, Toulouse
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 Reconstruction, run by University Hospital, Toulouse at 1 site in France.
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 1 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 10 Oct 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 France. 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?
Preparation time of the trolley (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2022.