Anterior Cruciate Ligament ReconstructionRELICANCT06819696
Tourniquet vs. Dual-flow Arthroscopy Sheath in Anterior Cruciate Ligament (ACL) Reconstruction
A study testing ACL reconstruction with a dual-flow arthroscopy sheath and ACL reconstruction with a thigh tourniquet in people with Anterior Cruciate Ligament Reconstruction, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 3 sites in France.
Trial summary
This is a prospective randomized study comparing tourniquet use versus a dual-flow arthroscopy sheath in Anterior Cruciate Ligament (ACL) reconstruction surgery. The ACL is largely responsible for knee stability and contributes to central pivot with the posterior cruciate ligament. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- ACL reconstruction with a dual-flow arthroscopy sheath and ACL reconstruction with a thigh tourniquet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 3 sitesFrance
- Study dates
- 12 May 2025to Apr 2028
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary ACL reconstruction
- Age 18 years or older
- Provided informed consent prior to study participation
- Affiliated to or beneficiary of a social security regimen
Who cannot join
- Multi-ligamentous surgery
- Revision ACL surgery
- Presence of a meniscal and/or chondral lesion not allowing immediate weight-bearing postoperatively
- Bleeding disorder
- Pregnant, parturient or breastfeeding women
- Patient under legal guardianship
- Any other reason which, in the opinion of the investigator, could interfere with the evaluation of the objectives of the study objectives
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Centre Hospitalier de Hyères
Hyères, Var, 83400
Cédric SIEDLECKI, MD, 04 94 14 50 00 ext. +33, cedric.siedlecki@ch-toulon.fr
- Not yet recruiting
CHU de Reims
Reims, Marne, 51100
Renaud SIBONI, MD, rsiboni@chu-reims.fr
- Recruiting
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
Toulon, Var, 83100
Jean-Charles ESCUDIER, MD, 04 94 14 50 00 ext. +33, jean-charles.escudier@ch-toulon.fr
About this study
Official title: A Prospective, Randomized Controlled Study Comparing Tourniquet Use Versus a Dual-flow Arthroscopy Sheath in Anterior Cruciate Ligament (ACL) Reconstruction Surgery.
This is a prospective randomized study comparing tourniquet use versus a dual-flow arthroscopy sheath in Anterior Cruciate Ligament (ACL) reconstruction surgery.
The ACL is largely responsible for knee stability and contributes to central pivot with the posterior cruciate ligament. ACL rupture is associated with a violent twisting motion of the knee, which is usually irreparable without surgical intervention.
Read more
ACL reconstruction via arthroscopy is the gold standard treatment for young, active patients with knee instability. Reconstruction is commonly performed using a thigh tourniquet to improve intraoperative visibility, reduce bleeding, and shorten procedure time. However, numerous studies associate tourniquet use with an increased risk of postoperative complications such as increased pain, muscle injury, postoperative bleeding, and deep vein thrombosis. Therefore, it seems relevant to conduct further investigations into the benefits of new methods to replace tourniquet. In this context, the dual-flow arthroscopy sheath could improve postoperative recovery after ACL reconstruction and could limit the risk of complications, thus improving ambulatory care for patients.
This study propose to compare two groups of patients undergoing ACL reconstruction: those operated on with a tourniquet versus those operated on using the dual-flow arthroscopy sheath.
Read the detailed description
Initial assessments will be conducted preoperatively. The follow-up examination will take place during the first 7 days following surgery and then at 21 days (D21), 45 days (D45), and 5 months postoperatively.
- Being tested
- ACL reconstruction with a dual-flow arthroscopy sheath, ACL reconstruction with a thigh tourniquet
- Keywords
- Anterior Cruciate Ligament, Arthroscopy, Dual-flow arthroscopy sheath, Tourniquet, pain, Surgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL reconstruction with a dual-flow arthroscopy sheathProcedure or surgery
ACL reconstruction will be performed by the surgeon without a tourniquet but using a dual-flow arthroscopy sheath.
ACL reconstruction with a thigh tourniquetProcedure or surgery
ACL reconstruction will be performed by the surgeon using a thight tourniquet
| Study group | Role | What they receive |
|---|---|---|
| Dual-flow arthroscopy sheath | Experimental | Patients will undergo ACL reconstruction using a dual-flow arthroscopy sheath. Receives: Procedure: ACL reconstruction with a dual-flow arthroscopy sheath |
| Thigh tourniquet | Active comparator | Patients will undergo ACL reconstruction using a thigh tourniquet. Receives: Procedure: ACL reconstruction with a thigh tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity according to a Numeric Rating Scale (NRS)
Pain intensity will be assessed using a Numeric Rating Scale (NRS) at 8 AM, 12 PM, and 8 PM on postoperative day 4.
The minimum value of the scale, corresponding to no pain at all, is 0 and the maximum value is 10.
Measured: 4 days after surgery
Secondary outcomes (14)
Pain intensity according to a Numeric Rating Scale (NRS)
Pain intensity will be assessed using a Numeric Rating Scale (NRS) on the day of surgery (preoperatively and at 4, 12, and 16 hours postoperatively) and on days 1, 2, and 3 following surgery (at 8 AM, 12 PM, and 8 PM).
The minimum value of the scale, corresponding to no pain at all, is 0 and the maximum value is 10.
Measured: Up to 3 days after surgery
Total antalgic consumption
Total antalgic consumption will be assessed in number of doses per type of drug, from surgery up to 4 days after surgery.
Measured: Up to 4 days after surgery
Arthrogenic Muscle Inhibition (AMI) classification
This classification is used to assess quadriceps contraction.
Measured: Preoperative, on Day 0 before and after surgery and then on Day 21 and Day 45 after surgery.
Lysholm knee scoring scale
The Lysholm Knee Score is a standardized questionnaire used to assess knee function after surgery. The total score obtained ranges from 0 to 100. The higher the score, the better the knee's function.
Measured: Preoperative, Day 21, Day 45 and Month 5 after surgery
Knee Blessure and Osteoarthritis Outcomescore (KOOS)
The KOOS is a self-administered questionnaire that evaluates multiple aspects of knee health, including pain, symptoms, daily living activities, sports and recreation function, and quality of life.
Each subscale is rated from 0 to 100, where 0 represents extreme problems and 100 represents no problem.
Measured: Preoperative, Day 21, Day 45 and Month 5 after surgery
Knee mobility
Knee mobility will be assessed using a goniometer.
Measured: Preoperative, Day 21, Day 45 and Month 5 after surgery
Total surgical time
Assessed in minutes
Measured: Day 0
Arthroscopic time
Assessed in minutes
Measured: During procedure
Intraoperative visibility
Intraoperative visibility will be assessed by the surgeon using a 4-point scale (excellent, good, fair, poor).
Measured: During procedure
Thigh, knee and calf diameters in cm
Diameters will be evaluated in cm.
Measured: Preoperative and Day 21
CPK blood level
Measured: Preoperative and Day 1
Hemoglobin level
Measured: Preoperative, Day 1 and Day 7
Presence of complications
The number and type of complications will be recorded, including hematomas, knee stiffness, deep vein thrombosis, complex regional pain syndrome, deep infection, superficial infection, and recurrent anterior cruciate ligament graft rupture.
Measured: Up to 5 months
Muscle strength
Muscle strength will be assessed in both limbs using isokinetic testing
Measured: Preoperative and 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start12 May 2025
- Primary completionNov 2027 (estimated)
- Study completionApr 2028 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cédric SIEDLECKI, MD, Study director, Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer and Centre Hospitalier de Hyères
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819696
- Sponsor's protocol ID
- 2024-CHITS-007
- Other IDs
- 2024-A01117-40
- Acronym
- RELICA
- Status last verified
- Jul 2026
- First submitted
- 5 Feb 2025
- Last updated
- 7 Jul 2026
- 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 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Study Comparing Tourniquet Use Versus a Dual-flow Arthroscopy Sheath in Anterior Cruciate Ligament (ACL) Reconstruction Surgery.
- ClinicalTrials.gov ID
- NCT06819696
- Acronym / sponsor ID
- RELICA / 2024-CHITS-007
- Keywords
- Anterior Cruciate Ligament, Arthroscopy, Dual-flow arthroscopy sheath, Tourniquet, pain, Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 11 Feb 2025 (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 is a prospective randomized study comparing tourniquet use versus a dual-flow arthroscopy sheath in Anterior Cruciate Ligament (ACL) reconstruction surgery.
The ACL is largely responsible for knee stability and contributes to central pivot with the posterior cruciate ligament. ACL rupture is associated with a violent twisting motion of the knee, which is usually irreparable without surgical intervention.
ACL reconstruction via arthroscopy is the gold standard treatment for young, active patients with knee instability. Reconstruction is commonly performed using a thigh tourniquet to improve intraoperative visibility, reduce bleeding, and shorten procedure time. However, numerous studies associate tourniquet use with an increased risk of postoperative complications such as increased pain, muscle injury, postoperative bleeding, and deep vein thrombosis. Therefore, it seems relevant to conduct further investigations into the benefits of new methods to replace tourniquet. In this context, the dual-flow arthroscopy sheath could improve postoperative recovery after ACL reconstruction and could limit the risk of complications, thus improving ambulatory care for patients.
This study propose to compare two groups of patients undergoing ACL reconstruction: those operated on with a tourniquet versus those operated on using the dual-flow arthroscopy sheath.
Detailed description
Initial assessments will be conducted preoperatively. The follow-up examination will take place during the first 7 days following surgery and then at 21 days (D21), 45 days (D45), and 5 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual-flow arthroscopy sheath | Experimental | Procedure: ACL reconstruction with a dual-flow arthroscopy sheathPatients will undergo ACL reconstruction using a dual-flow arthroscopy sheath. |
| Thigh tourniquet | Active comparator | Procedure: ACL reconstruction with a thigh tourniquetPatients will undergo ACL reconstruction using a thigh tourniquet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary ACL reconstruction
- Age 18 years or older
- Provided informed consent prior to study participation
- Affiliated to or beneficiary of a social security regimen
Key exclusion criteria (7 listed)
- Multi-ligamentous surgery
- Revision ACL surgery
- Presence of a meniscal and/or chondral lesion not allowing immediate weight-bearing postoperatively
- Bleeding disorder
- Pregnant, parturient or breastfeeding women
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 |
|---|---|---|
| ACL reconstruction with a dual-flow arthroscopy sheathACL reconstruction will be performed by the surgeon without a tourniquet but using a dual-flow arthroscopy sheath. | Procedure or surgery | Dual-flow arthroscopy sheath |
| ACL reconstruction with a thigh tourniquetACL reconstruction will be performed by the surgeon using a thight tourniquet | Procedure or surgery | Thigh tourniquet |
Primary outcome
Postoperative pain intensity according to a Numeric Rating Scale (NRS)
Time frame: 4 days after surgery
Pain intensity will be assessed using a Numeric Rating Scale (NRS) at 8 AM, 12 PM, and 8 PM on postoperative day 4. The minimum value of the scale, corresponding to no pain at all, is 0 and the maximum value is 10.
14 secondary outcomes
Pain intensity according to a Numeric Rating Scale (NRS)
Time frame: Up to 3 days after surgery
Total antalgic consumption
Time frame: Up to 4 days after surgery
Arthrogenic Muscle Inhibition (AMI) classification
Time frame: Preoperative, on Day 0 before and after surgery and then on Day 21 and Day 45 after surgery.
Lysholm knee scoring scale
Time frame: Preoperative, Day 21, Day 45 and Month 5 after surgery
Knee Blessure and Osteoarthritis Outcomescore (KOOS)
Time frame: Preoperative, Day 21, Day 45 and Month 5 after surgery
Knee mobility
Time frame: Preoperative, Day 21, Day 45 and Month 5 after surgery
Total surgical time
Time frame: Day 0
Arthroscopic time
Time frame: During procedure
Intraoperative visibility
Time frame: During procedure
Thigh, knee and calf diameters in cm
Time frame: Preoperative and Day 21
CPK blood level
Time frame: Preoperative and Day 1
Hemoglobin level
Time frame: Preoperative, Day 1 and Day 7
Presence of complications
Time frame: Up to 5 months
Muscle strength
Time frame: Preoperative and 5 months
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 7 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament Reconstruction
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Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
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Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
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Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Interventions to Enhance Quadriceps Output After ACLR
ACL
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
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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.
Cédric SIEDLECKI, MD study director
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer and Centre Hospitalier de Hyères
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACL reconstruction with a dual-flow arthroscopy sheath and ACL reconstruction with a thigh tourniquet in people with Anterior Cruciate Ligament Reconstruction, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 3 sites 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 4 inclusion and 7 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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 Magali CESANA (04 83 77 20 60 ext. +33, magali.cesana@ch-toulon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity according to a Numeric Rating Scale (NRS) (time frame: 4 days after surgery). 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 7 Jul 2026.