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New treatment option for Medial Patellofemoral Ligament (MPFL) Reconstruction
Official title Evaluation of Pain Management After Surgery When Using Exparel in the Pediatric Population
ClinicalTrials.gov ID: NCT06559215
What this study is testing
What is Exparel?
Exparel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for medial patellofemoral ligament (mpfl) reconstruction.
Also referred to as Liposomal bupivacaine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this randomized clinical trial is to determine if administration of Exparel via local infiltration for medial patellofemoral ligament (MPFL) reconstruction procedures in pediatric orthopaedic sports medicine patients provides significant pain relief and decreased narcotic use. The main questions it aims to answer are: Does Exparel significantly reduce Visual Analog Scale (VAS) pain scores and pain levels up to one week postoperatively?
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 21
You may be able to join if
- Must be aged 13+ years at time of surgery
- Must present with injury requiring an isolated MPFL Reconstruction
- Ability to provide assent, legally appointed representative available to provide informed consent
You likely can't join if
- Patient \<13 years old
- Requires fracture repair or another non-standardized surgery
- Any MPFL Reconstruction that requires the use of arthrotomy or a tibial tubercle osteotomy
- Any lower extremity procedure that is not an isolated MPFL Reconstruction
- Patient pregnancy
- Inability to provide assent or legally appointed representative to provide informed consent
See the full eligibility criteria
- Must be aged 13+ years at time of surgery
- Must present with injury requiring an isolated MPFL Reconstruction
- Ability to provide assent, legally appointed representative available to provide informed consent
- Patient \<13 years old
- Requires fracture repair or another non-standardized surgery
- Any MPFL Reconstruction that requires the use of arthrotomy or a tibial tubercle osteotomy
- Any lower extremity procedure that is not an isolated MPFL Reconstruction
- Patient pregnancy
- Inability to provide assent or legally appointed representative to provide informed consent
- Prior history of hypersensitivity to Exparel or any local anesthesia
- BMI ≥ 40
The study team makes the final eligibility decision.
Where it's taking place
- Frisco, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Frisco, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.