Anterior cruciate ligament(ACL) tear requiring arthroscopic ACL reconstruction, with emphasis on early postoperative outcomes including pain, hemarthrosis, and knee functions Anterior cruciate ligament tear, Arthroscopic Anterior cruciate ligament reconstruction, Platelet-Rich Plasma, Fibrin Sealant, Autologous Transplantation, Postoperative pain, Hemarthrosis, Joint Range of Motion
Conditions
Interventions
1. While the patient is in the waiting room 30 minutes prior to surgery, 35 ml of blood will be drawn from the median cubital vein. All equipment will be provided by the Cellular Therapy Center team.
s 35 ml blood sample will be taken back to prepare the Autologous Platelet Gel Bioseal biological product. The preparation procedure will be conducted by researchers from the Cellular Therapy Center K
s blood will be centrifuged to prepare platelet rich plasma (PRP) and autologous thrombin, resulting in a total of 4 syringes of product.
3. Once prepared, staff from the Cellular Therapy Center KKU w
s blood to the Cellular Therapy Center KKU and back, including the preparation process, is 1 hour and 30 minutes.
4. Before injection into the patient, all 4 syringes must be mixed together with a pla
Experimental Biological/Vaccine,Active Comparator Procedure/Surgery
Autologous Platelet Gel Bioseal,Standard Arthroscopic ACL reconstruction (no Bioseal)
Sponsors
Faculty of medicine, Khon Kaen University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-60 years 2. Patients diagnosed with anterior cruciate ligament tear requiring arthroscopic reconstruction using a hamstring autograft 3. Patients undergoing surgery under spinal anesthesia
Exclusion criteria
Exclusion criteria: 1.Patients with a blood Hemoglobin level of less than 10 g/dL. 2.Patients with a blood Platelet count of less than 100,000 g/dL. 3.Patients with contraindications for the use of Autologous Platelet Gel Bioseal, such as platelet disorders or severe osteoarthritis. 4.Patients receiving antiplatelet medication. 5.Patients with a current active infection or inflammation affecting the knee undergoing arthroscopic surgery. 6.Patients with systemic diseases affecting platelet function, such as autoimmune disorders or severe diabetes. 7.Patients currently on anticoagulant therapy. 8.Patients with renal insufficiency (GFR < 30 ml/min). 9.Patients at risk of a cardiovascular thrombotic event, such as myocardial infarction or thrombotic stroke. 10.Patients with gastrointestinal diseases, such as peptic ulcer or active GI bleed. 11.Patients who have undergone previous knee surgery on the affected side for ACL reconstruction. 12.Patients with other injured knee ligaments requiring surgical treatment or a concomitant bone fracture. 13.Patients with substance abuse issues (drugs, alcohol) or chronic pain conditions. 14.Patients who received steroid medication within 48 hours before the day of surgery. 15.Patients with psychiatric issues, intellectual impairment, lack of cooperation, or communication problems. 16.Patients who refuse to participate in the research project. 17.Patients with a history of allergy to the medications used in the study, including morphine, Dynastat, and ketorolac. 18.Patients with contraindications for spinal anesthesia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative pain 24 hours post-surgery. Visual Analogue Scale (VAS) at rest and during passive knee flexion at 60 degrees | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative pain 6, 12 hours and 2 weeks post-surgery Visual Analogue Scale (VAS) at rest and during passive knee flexion at 60 degrees,Postoperative pain 6, 12, 18, and 24 hours post-surgery Recording the frequency of patient requests for 2 mg intravenous morphine every 2 hours to manage pain,Ability to perform a straight leg raise (SLR) and the knee joint range of motion (ROM) Before, After arthroscopic ACL reconstruction surgery (at 24 hours and 2 weeks post-surgery) straight leg raise (SLR) and the knee joint range of motion (ROM),Level of knee joint swelling Before, After arthroscopic ACL reconstruction surgery (at 24 hours and 2 weeks post-surgery) Ballottement test, Knee circumference,Knee function Before, After arthroscopic ACL reconstruction surgery (at 2 weeks post-surgery) Lysholm Knee Scoring Scale,Satisfaction score 2 weeks post-surgery Satisfaction score | — |
Countries
Thailand
Contacts
Public ContactSahachok Sahabantoengsin
Khon Kaen University
Outcome results
None listed