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

NCT07815743 | Not Yet Recruiting

• 1 other identifier: OR26-00007
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Meniscal Tears

Keywords

Meniscal Repair; Meniscal Injury; Platelet-Rich Plasma; Leukocyte-Poor Platelet-Rich Plasma; LP-PRP; Knee Arthroscopy

Outcome Measures

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.

  Baseline (preoperative), 3 months, and 6 months postoperatively

Secondary Outcomes (2)

• Change in Pain Intensity Assessed by the Visual Analog Scale

  Baseline (preoperative), 2 weeks, 1 month, 3 months, and 6 months postoperatively

• Time to Return to Usual Activity

  From surgery through 6 months postoperatively

Study Arms (2)

Meniscal Repair With LP-PRP

EXPERIMENTAL

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

Conventional Meniscal Repair

ACTIVE COMPARATOR

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

Interventions

Leukocyte-poor platelet-rich plasma BIOLOGICAL

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 With LP-PRP

Meniscal Repair PROCEDURE

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.

Conventional Meniscal Repair; Meniscal Repair With LP-PRP

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Ability to provide informed consent and comply with the 6-month clinical follow-up schedule.

You may not qualify if:

• 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.
• Advanced chondral damage, defined as Outerbridge grade III or IV, or significant osteoarthritis.
• Irreparable meniscal lesions or cases not considered candidates for meniscal repair.
• Known allergy or hypersensitivity to PRP or components used in its preparation.
• Inability to complete the required 6-month clinical follow-up.

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead

Study Sites (1)

Hospital Universitario "Dr. José Eleuterio González"

Monterrey, Nuevo León, 64460, Mexico

Location

Study Officials

• Domingo Garay Mendoza, MD

  Universidad Autonoma de Nuevo Leon

  STUDY DIRECTOR

• Marcelo Ramírez Vela

  Universidad Autonoma de Nuevo Leon

  STUDY CHAIR

• Felix Vilchez Cavazos, MD

  Universidad Autonoma de Nuevo Leon

  STUDY DIRECTOR

• Rodolfo Morales Avalos, MD

  Universidad Autonoma de Nuevo Leon

  PRINCIPAL INVESTIGATOR

• Luis Roberto García García, MD

  Universidad Autonoma de Nuevo Leon

  STUDY DIRECTOR

Central Study Contacts

Rodolfo Morales Avalos, MD

CONTACT

+528116543223; rodolfo.moralesav@uanl.edu.mx

Luis Roberto García García, MD

CONTACT

+528112169420; luisrobertogarciag@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and data analysts will be blinded to treatment allocation. The operating surgeon cannot be blinded because the surgeon performs the intraoperative LP-PRP application.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to one of two parallel groups: meniscal repair augmented with intraoperative intralesional LP-PRP or conventional meniscal repair without biological augmentation.

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)