Anterior Cruciate Ligament Reconstruction
Conditions
Keywords
Anterior Cruciate Ligament, Arthroscopy, Dual-flow arthroscopy sheath, Tourniquet, pain, Surgery
Brief 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. 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.
Interventions
PROCEDUREACL reconstruction with a dual-flow arthroscopy sheath
ACL reconstruction will be performed by the surgeon without a tourniquet but using a dual-flow arthroscopy sheath.
PROCEDUREACL reconstruction with a thigh tourniquet
ACL reconstruction will be performed by the surgeon using a thight tourniquet
Sponsors
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The patient will be masked to the surgical procedure and will be unblinded upon completion of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary ACL reconstruction * Age 18 years or older * Provided informed consent prior to study participation * Affiliated to or beneficiary of a social security regimen
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity according to a Numeric Rating Scale (NRS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity according to a Numeric Rating Scale (NRS) | Up to 3 days after surgery | 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. |
| Total antalgic consumption | Up to 4 days after surgery | Total antalgic consumption will be assessed in number of doses per type of drug, from surgery up to 4 days after surgery. |
| Arthrogenic Muscle Inhibition (AMI) classification | Preoperative, on Day 0 before and after surgery and then on Day 21 and Day 45 after surgery. | This classification is used to assess quadriceps contraction. |
| Lysholm knee scoring scale | Preoperative, Day 21, Day 45 and Month 5 after surgery | 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. |
| Knee Blessure and Osteoarthritis Outcomescore (KOOS) | Preoperative, Day 21, Day 45 and Month 5 after surgery | 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. |
| Knee mobility | Preoperative, Day 21, Day 45 and Month 5 after surgery | Knee mobility will be assessed using a goniometer. |
| Total surgical time | Day 0 | Assessed in minutes |
| Arthroscopic time | During procedure | Assessed in minutes |
| Intraoperative visibility | During procedure | Intraoperative visibility will be assessed by the surgeon using a 4-point scale (excellent, good, fair, poor). |
| Thigh, knee and calf diameters in cm | Preoperative and Day 21 | Diameters will be evaluated in cm. |
| CPK blood level | Preoperative and Day 1 | — |
| Hemoglobin level | Preoperative, Day 1 and Day 7 | — |
| Presence of complications | Up to 5 months | 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. |
| Muscle strength | Preoperative and 5 months | Muscle strength will be assessed in both limbs using isokinetic testing |
Countries
France
Contacts
CONTACTMagali CESANA
CONTACTSteven LAUJAC
STUDY_DIRECTORCédric SIEDLECKI, MD
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer and Centre Hospitalier de Hyères
Outcome results
None listed