About this trial
This prospective, randomized, comparative clinical study will evaluate the clinical and functional outcomes of meniscal repair augmented with intraoperative intralesional leukocyte-poor platelet-rich plasma (LP-PRP) compared with conventional meniscal repair without biological augmentation. A total of 62 participants aged 18 to 40 years undergoing meniscal repair will be assigned to either the LP-PRP group or the control group. Participants will be followed for 6 months after surgery. Clinical outcomes will include knee function assessed using the International Knee Documentation Committee (IKDC) questionnaire, pain intensity assessed using the Visual Analog Scale (VAS), time to return to usual activities, and adverse events or complications. Assessments will be performed preoperatively and during postoperative follow-up at 2 weeks, 1 month, 3 months, and 6 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 40 years, with confirmed skeletal maturity.
Indication for primary meniscal repair, with no previous interventions in the same knee joint.
Repairable meniscal lesions, including horizontal, vertical longitudinal, radial, oblique, or complex tear patterns, provided that biomechanical stability criteria are met after suturing.
Lesions located in anatomical zones with healing potential (red-red or red-white zones), or lesions in the white-white zone considered repairable by the treating surgeon.
Disqualifiers
Metabolic or systemic diseases that may impair healing (e.g., uncontrolled diabetes).
Active rheumatic or inflammatory diseases, such as rheumatoid arthritis.
Previous surgery in the same knee joint.
Recent use of nonsteroidal anti-inflammatory drugs (NSAIDs) that may interfere with the effects of PRP.
Trial design
Parallel
Treatments tested in this trial
Leukocyte-poor platelet-rich plasma
Biological/VaccineLeukocyte-poor platelet-rich plasma (LP-PRP) will be prepared from approximately 60 mL of autologous venous blood using a standardized manual double-centrifugation technique. The LP-PRP will be activated with 10% calcium chloride and applied intraoperatively and intralesionally directly to the meniscal lesion between the sutured edges during meniscal repair.
Meniscal Repair
Procedure/SurgeryParticipants will undergo meniscal repair using the surgical technique indicated according to the characteristics and location of the meniscal lesion. The same surgical and postoperative care principles will be applied to both study arms.
Treatment groups
Trial outcomes
Primary outcomes
Change in Knee Function Assessed by the IKDC Subjective Knee Form
Knee function will be assessed using the International Knee Documentation Committee (IKDC) Subjective Knee Form. The IKDC score ranges from 0 to 100, with higher scores indicating better knee function. Changes in IKDC scores will be compared between the LP-PRP and conventional meniscal repair groups.
Secondary outcomes
Change in Pain Intensity Assessed by the Visual Analog Scale
Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Changes in VAS scores over time will be compared between the LP-PRP and conventional meniscal repair groups.
Time to Return to Usual Activity
Time from surgery to return to usual activities will be recorded during postoperative follow-up. Return to usual activity includes resumption of daily, occupational, physical, and sports activities, as applicable. Time to return will be compared between the LP-PRP and conventional meniscal repair groups.
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