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

N/ANot Yet RecruitingNCT07815743

Universidad Autonoma de Nuevo Leon62 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Interventions

Leukocyte-poor platelet-rich plasmaBIOLOGICAL

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 RepairPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18 to 40 years, with confirmed skeletal maturity. 2. Indication for primary meniscal repair, with no previous interventions in the same knee joint. 3. Repairable meniscal lesions, including horizontal, vertical longitudinal, radial, oblique, or complex tear patterns, provided that biomechanical stability criteria are met after suturing. 4. 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. 5. Ability to provide informed consent and comply with the 6-month clinical follow-up schedule. Exclusion Criteria: 1. Metabolic or systemic diseases that may impair healing (e.g., uncontrolled diabetes). 2. Active rheumatic or inflammatory diseases, such as rheumatoid arthritis. 3. Previous surgery in the same knee joint. 4. Recent use of nonsteroidal anti-inflammatory drugs (NSAIDs) that may interfere with the effects of PRP. 5. Advanced chondral damage, defined as Outerbridge grade III or IV, or significant osteoarthritis. 6. Irreparable meniscal lesions or cases not considered candidates for meniscal repair. 7. Known allergy or hypersensitivity to PRP or components used in its preparation. 8. Inability to complete the required 6-month clinical follow-up.

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.

Time frame: Baseline (preoperative), 3 months, and 6 months postoperatively

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 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