An interventional study of Leukocyte-poor platelet-rich plasma and Meniscal Repair in Meniscal Tears, sponsored by Universidad Autonoma de Nuevo Leon. Not yet recruiting at 1 site in Mexico. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Universidad Autonoma de Nuevo Leon · Not applicable, Interventional, and Treatment
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.
This prospective, randomized, comparative, longitudinal clinical study will include 62 adult participants aged 18 to 40 years undergoing primary meniscal repair. Participants will be assigned to two parallel groups: an intervention group receiving leukocyte-poor platelet-rich plasma (LP-PRP) as biological augmentation during meniscal repair and a control group undergoing conventional meniscal repair without biological augmentation.
Participants assigned to the intervention group will have approximately 60 mL of autologous venous blood collected before surgery for preparation of LP-PRP using a standardized manual double-centrifugation technique. The LP-PRP will be activated with 10% calcium chloride and applied intraoperatively directly into the meniscal lesion between the recently sutured edges. Participants in the control group will undergo conventional meniscal repair without PRP or other biological adjuvants. Surgical techniques and postoperative care will otherwise be comparable between groups.
Participants will be followed for 6 months. Clinical assessments will be performed preoperatively and at 2 weeks, 1 month, 3 months, and 6 months after surgery. Pain intensity will be evaluated using the Visual Analog Scale (VAS) at all assessment points. Knee function will be evaluated using the International Knee Documentation Committee (IKDC) questionnaire preoperatively and at 3 and 6 months. Return to usual activities and the occurrence of adverse events or complications will be documented during postoperative follow-up.
Clinical evaluators, outcome assessors, and data analysts will remain blinded to treatment allocation to minimize measurement and interpretation bias.
Universidad Autonoma de Nuevo Leon is the lead sponsor of 53 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm will undergo meniscal repair augmented with intraoperative intralesional leukocyte-poor platelet-rich plasma (LP-PRP). Approximately 60 mL of autologous venous blood will be collected before surgery for LP-PRP preparation using a standardized manual double-centrifugation technique. The LP-PRP will be activated with 10% calcium chloride and applied directly to the meniscal lesion between the sutured edges.
Biological: Leukocyte-poor platelet-rich plasma · Procedure: Meniscal Repair
Participants assigned to this arm will undergo conventional meniscal repair without platelet-rich plasma (PRP) or other biological augmentation. Surgical technique and postoperative care will otherwise be comparable to those used in the experimental arm.
Procedure: Meniscal Repair
Leukocyte-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.
Participants 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.
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.
Time frame: Baseline (preoperative), 3 months, and 6 months postoperatively
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 frame: Baseline (preoperative), 2 weeks, 1 month, 3 months, and 6 months postoperatively
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.
Time frame: From surgery through 6 months postoperatively
Plan to share: No — Individual participant data will not be shared because the approved study protocol and informed consent do not include a general plan for sharing individual-level participant data with other researchers. Participant information will be maintained confidentially and protected through coded identifiers in accordance with institutional policies and applicable data protection regulations.
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Universidad Autonoma de Nuevo Leon