ACL InjuryNCT07683247
Intraoperative Energy Expenditure During ACL Reconstruction Surgery
An observational study of ACL Injury and Meniscal Injuries, run by ASL Lecce at 1 site in Italy.
Trial summary
This prospective observational study evaluates the intraoperative energy expenditure of the surgeon during anterior cruciate ligament reconstruction procedures. Energy expenditure and physiological workload will be measured using a wearable Hexoskin shirt during surgery. Read more about this study
- Who is it for?
- Ages 16 to 49 years
- Conditions the study is for
- ACL Injury, Meniscal Injuries
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2025to 31 Dec 2026
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 to 49 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: he study population will include patients undergoing primary anterior cruciate ligament (ACL) reconstruction at the participating center. Patients may undergo isolated ACL reconstruction, ACL reconstruction combined with anterolateral ligament (ALL) reconstruction, ACL reconstruction with associated meniscal treatment, or ACL reconstruction combined with both ALL reconstruction and meniscal treatment. During each surgical procedure, the operating surgeon will wear a Hexoskin device to record intraoperative physiological parameters and estimate energy expenditure. Surgical indication and associated procedures will be determined according to standard clinical practice.
Who may be able to join
- Patients undergoing primary anterior cruciate ligament reconstruction
- Unilateral ACL rupture confirmed by clinical examination and MRI
- Surgery performed by the participating surgeon wearing the Hexoskin device
- Ability to provide written informed consent
Who cannot join
- Revision ACL reconstruction
- Multiligament knee reconstruction
- Bilateral knee surgery
- Concomitant procedures other than ACL reconstruction, ALL reconstruction, meniscal repair, or partial meniscectomy
- Incomplete intraoperative Hexoskin recording
- Conversion or interruption of the planned surgical procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Vito Fazzi Hospital
Lecce
Jacopo Conteduca, MD, 0039 3332280645, conteduca85@gmail.com
About this study
Official title: Prospective Assessment of Surgeon Energy Expenditure Using Hexoskin During Anterior Cruciate Ligament Reconstruction: Influence of Anterolateral Ligament Reconstruction and Meniscal Procedures
This prospective observational study evaluates the intraoperative energy expenditure of the surgeon during anterior cruciate ligament reconstruction procedures. Energy expenditure and physiological workload will be measured using a wearable Hexoskin shirt during surgery.
The study will compare surgical procedures involving isolated anterior cruciate ligament reconstruction, anterior cruciate ligament reconstruction combined with anterolateral ligament reconstruction, and procedures requiring additional meniscal treatment. The aim is to determine whether anterolateral ligament reconstruction meaningfully increases surgeon workload and whether meniscal procedures are associated with higher intraoperative energy expenditure.
- Conditions
- ACL Injury, Meniscal Injuries
- Keywords
- Anterior cruciate ligament, Hexoskin, ACL reconstruction, Wearable monitoring, Knee surgery
- 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 |
|---|---|---|
| Isolated ACL Reconstruction | Patients undergoing primary anterior cruciate ligament (ACL) reconstruction without anterolateral ligament (ALL) reconstruction and without meniscal treatment. | |
| ACL Reconstruction With ALL Reconstruction | Patients undergoing primary ACL reconstruction combined with anterolateral ligament (ALL) reconstruction, without associated meniscal treatment. | |
| ACL Reconstruction With Meniscal Treatment | Patients undergoing primary ACL reconstruction with associated meniscal repair or partial meniscectomy, without ALL reconstruction. | |
| ACL Reconstruction With ALL Reconstruction and Meniscal Treatment | Patients undergoing primary ACL reconstruction combined with ALL reconstruction and associated meniscal repair or partial meniscectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Energy Expenditure
Total intraoperative energy expenditure of the operating surgeon measured using the Hexoskin wearable device, expressed in kilocalories.
Measured: During surgery, from skin incision to wound closure
Secondary outcomes (3)
minute ventilation
Mean minute ventilation of the operating surgeon measured during the surgical procedure using the Hexoskin wearable device, expressed in liters per minute.
Measured: During surgery, from skin incision to wound closure.
Mean heart rate
Mean heart rate of the operating surgeon measured during the surgical procedure using the Hexoskin wearable device, expressed in beats per minute.
Measured: During surgery, from skin incision to wound closure.
surgical time
Total surgical time, measured in minutes, from skin incision to wound closure.
Measured: during surgery, from skin incision to wound closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Feb 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- ASL Lecce
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jacopo Conteduca, ASL Lecce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683247
- Sponsor's protocol ID
- HEX-ACL-2026-01
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during this study will not be made publicly available because informed consent for data sharing was not obtained and data are subject to institutional privacy and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Surgeon Energy Expenditure Using Hexoskin During Anterior Cruciate Ligament Reconstruction: Influence of Anterolateral Ligament Reconstruction and Meniscal Procedures
- ClinicalTrials.gov ID
- NCT07683247
- Acronym / sponsor ID
- HEX-ACL-2026-01
- Conditions
- ACL Injury, Meniscal Injuries
- Keywords
- Anterior cruciate ligament, Hexoskin, ACL reconstruction, Wearable monitoring, Knee surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- ASL LecceOther government
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Jul 2026 (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.
This prospective observational study evaluates the intraoperative energy expenditure of the surgeon during anterior cruciate ligament reconstruction procedures. Energy expenditure and physiological workload will be measured using a wearable Hexoskin shirt during surgery.
The study will compare surgical procedures involving isolated anterior cruciate ligament reconstruction, anterior cruciate ligament reconstruction combined with anterolateral ligament reconstruction, and procedures requiring additional meniscal treatment. The aim is to determine whether anterolateral ligament reconstruction meaningfully increases surgeon workload and whether meniscal procedures are associated with higher intraoperative energy expenditure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Isolated ACL Reconstruction | – | –Patients undergoing primary anterior cruciate ligament (ACL) reconstruction without anterolateral ligament (ALL) reconstruction and without meniscal treatment. |
| ACL Reconstruction With ALL Reconstruction | – | –Patients undergoing primary ACL reconstruction combined with anterolateral ligament (ALL) reconstruction, without associated meniscal treatment. |
| ACL Reconstruction With Meniscal Treatment | – | –Patients undergoing primary ACL reconstruction with associated meniscal repair or partial meniscectomy, without ALL reconstruction. |
| ACL Reconstruction With ALL Reconstruction and Meniscal Treatment | – | –Patients undergoing primary ACL reconstruction combined with ALL reconstruction and associated meniscal repair or partial meniscectomy. |
Who may qualify
- Ages
- 16 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- he study population will include patients undergoing primary anterior cruciate ligament (ACL) reconstruction at the participating center. Patients may undergo isolated ACL reconstruction, ACL reconstruction combined with anterolateral ligament (ALL) reconstruction, ACL reconstruction with associated meniscal treatment, or ACL reconstruction combined with both ALL reconstruction and meniscal treatment. During each surgical procedure, the operating surgeon will wear a Hexoskin device to record intraoperative physiological parameters and estimate energy expenditure. Surgical indication and associated procedures will be determined according to standard clinical practice.
Key inclusion criteria (4 listed)
- Patients undergoing primary anterior cruciate ligament reconstruction
- Unilateral ACL rupture confirmed by clinical examination and MRI
- Surgery performed by the participating surgeon wearing the Hexoskin device
- Ability to provide written informed consent
Key exclusion criteria (6 listed)
- Revision ACL reconstruction
- Multiligament knee reconstruction
- Bilateral knee surgery
- Concomitant procedures other than ACL reconstruction, ALL reconstruction, meniscal repair, or partial meniscectomy
- Incomplete intraoperative Hexoskin recording
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
Total Energy Expenditure
Time frame: During surgery, from skin incision to wound closure
Total intraoperative energy expenditure of the operating surgeon measured using the Hexoskin wearable device, expressed in kilocalories.
3 secondary outcomes
minute ventilation
Time frame: During surgery, from skin incision to wound closure.
Mean heart rate
Time frame: During surgery, from skin incision to wound closure.
surgical time
Time frame: during surgery, from skin incision to wound closure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data collected during this study will not be made publicly available because informed consent for data sharing was not obtained and data are subject to institutional privacy and ethical restrictions.
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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.
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 ACL Injury and Meniscal Injuries, run by ASL Lecce at 1 site in Italy.
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 4 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacopo Conteduca, md (0039 3332280645, conteduca85@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Energy Expenditure (time frame: During surgery, from skin incision to wound closure). 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 13 Oct 2026.