Clinical Outcomes and Postoperative Recovery Following Meniscal Repair Augmented With Intraoperative Intralesional Leukocyte-Poor Platelet-Rich Plasma: A Prospective Comparative Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change in Knee Function Assessed by the IKDC Subjective Knee Form
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Meniscal Repair With LP-PRP
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.
干预措施: Leukocyte-poor platelet-rich plasma (Biological)
Meniscal Repair With LP-PRP
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.
干预措施: Meniscal Repair (Procedure)
Conventional 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.
干预措施: Meniscal Repair (Procedure)
结局指标
主要结局
Change in Knee Function Assessed by the IKDC Subjective Knee Form
时间窗: Baseline (preoperative), 3 months, and 6 months postoperatively
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.
次要结局
- 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)
研究者
Rodolfo Morales Avalos
Principal Investigator
Universidad Autonoma de Nuevo Leon