Meniscal Repair Augmented With Leukocyte-Poor Platelet-Rich Plasma: A Prospective Comparative Clinical Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversidad Autonoma de Nuevo Leon

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Leukocyte-poor platelet-rich plasma

    Biological/Vaccine

    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.

  • Meniscal Repair

    Procedure/Surgery

    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.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Meniscal Repair With LP-PRPExperimental treatment 2 interventions
Group B: Conventional Meniscal RepairActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

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