Meniscal TearsNCT07815743
Meniscal Repair Augmented With Leukocyte-Poor Platelet-Rich Plasma: A Prospective Comparative Clinical Study
A study testing Leukocyte-poor platelet-rich plasma and Meniscal Repair in people with Meniscal Tears, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Meniscal Tears
- What is being tested?
- Leukocyte-poor platelet-rich plasma and Meniscal Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Hospital Universitario "Dr. José Eleuterio González"
Monterrey, Nuevo León, 64460
Rodolfo Morales Avalos, MD, +528116543223, rodolfo.moralesav@uanl.edu.mx
Luis Roberto García García, MD, +528112169420, luisrobertogarciag@gmail.com
About this study
Official title: Clinical Outcomes and Postoperative Recovery Following Meniscal Repair Augmented With Intraoperative Intralesional Leukocyte-Poor Platelet-Rich Plasma: A Prospective Comparative Clinical Study
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.
Read the detailed description
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.
- Conditions
- Meniscal Tears
- Being tested
- Leukocyte-poor platelet-rich plasma, Meniscal Repair
- Keywords
- Meniscal Repair, Meniscal Injury, Platelet-Rich Plasma, Leukocyte-Poor Platelet-Rich Plasma, LP-PRP, Knee Arthroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Meniscal Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (preoperative), 3 months, and 6 months postoperatively
Secondary outcomes (2)
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.
Measured: 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.
Measured: From surgery through 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscal TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodolfo Morales Avalos, Universidad Autonoma de Nuevo Leon
- Investigators
- Domingo Garay Mendoza, MD, Study director, Universidad Autonoma de Nuevo LeonMarcelo Ramírez Vela, Study chair, Universidad Autonoma de Nuevo LeonFelix Vilchez Cavazos, MD, Study director, Universidad Autonoma de Nuevo LeonRodolfo Morales Avalos, MD, Principal investigator, Universidad Autonoma de Nuevo LeonLuis Roberto García García, MD, Study director, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815743
- Sponsor's protocol ID
- OR26-00007
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes and Postoperative Recovery Following Meniscal Repair Augmented With Intraoperative Intralesional Leukocyte-Poor Platelet-Rich Plasma: A Prospective Comparative Clinical Study
- ClinicalTrials.gov ID
- NCT07815743
- Acronym / sponsor ID
- OR26-00007
- Conditions
- Meniscal Tears
- Keywords
- Meniscal Repair, Meniscal Injury, Platelet-Rich Plasma, Leukocyte-Poor Platelet-Rich Plasma, LP-PRP, Knee Arthroscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Meniscal Repair With LP-PRP | Experimental | Biological: Leukocyte-poor platelet-rich plasma, Procedure: Meniscal RepairParticipants 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. |
| Conventional Meniscal Repair | Active comparator | Procedure: Meniscal RepairParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leukocyte-poor platelet-rich plasmaLeukocyte-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. | Biological | Meniscal Repair With LP-PRP |
| Meniscal RepairParticipants 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. | Procedure or surgery | Conventional Meniscal Repair, Meniscal Repair With LP-PRP |
Primary outcome
Change in Knee Function Assessed by the IKDC Subjective Knee Form
Time frame: 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.
2 secondary outcomes
Change in Pain Intensity Assessed by the Visual Analog Scale
Time frame: Baseline (preoperative), 2 weeks, 1 month, 3 months, and 6 months postoperatively
Time to Return to Usual Activity
Time frame: From surgery through 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Domingo Garay Mendoza, MD study director
Universidad Autonoma de Nuevo Leon
Marcelo Ramírez Vela study chair
Universidad Autonoma de Nuevo Leon
Felix Vilchez Cavazos, MD study director
Universidad Autonoma de Nuevo Leon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leukocyte-poor platelet-rich plasma and Meniscal Repair in people with Meniscal Tears, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rodolfo Morales Avalos, MD (+528116543223, rodolfo.moralesav@uanl.edu.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Function Assessed by the IKDC Subjective Knee Form (time frame: Baseline (preoperative), 3 months, and 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.