Tourniquet vs. Dual-flow Arthroscopy Sheath in Anterior Cruciate Ligament (ACL) Reconstruction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Intercommunal de Toulon La Seyne sur Mer

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Primary ACL reconstruction

Age 18 years or older

Provided informed consent prior to study participation

Affiliated to or beneficiary of a social security regimen

Disqualifiers

Multi-ligamentous surgery

Revision ACL surgery

Presence of a meniscal and/or chondral lesion not allowing immediate weight-bearing postoperatively

Bleeding disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • ACL reconstruction with a dual-flow arthroscopy sheath

    Procedure/Surgery

    ACL reconstruction will be performed by the surgeon without a tourniquet but using a dual-flow arthroscopy sheath.

  • ACL reconstruction with a thigh tourniquet

    Procedure/Surgery

    ACL reconstruction will be performed by the surgeon using a thight tourniquet

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Dual-flow arthroscopy sheathExperimental treatment 1 intervention
Group B: Thigh tourniquetActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
4 days after surgery

Secondary outcomes

1

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.

Time frame
Up to 3 days after surgery
2

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.

Time frame
Up to 4 days after surgery
3

Arthrogenic Muscle Inhibition (AMI) classification

This classification is used to assess quadriceps contraction.

Time frame
Preoperative, on Day 0 before and after surgery and then on Day 21 and Day 45 after surgery.
4

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.

Time frame
Preoperative, Day 21, Day 45 and Month 5 after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.