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Procedure
Tourniquet Use for Anterior Cruciate Ligament Repair
N/A
Waitlist Available
Led By Jonathan Riboh, MD
Research Sponsored by OrthoCarolina Research Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial assesses the effects of limited tourniquet use in ACL reconstruction surgery, aiming to reduce patient pain and speed up quadriceps recovery.
Who is the study for?
This trial is for English-speaking adults over 18 who need ACL reconstruction using their own patellar tendon and can attend specific physical therapy locations. It's not for those with additional knee surgeries, bleeding disorders, or allergies to certain medications used in the study.
What is being tested?
The study tests if using a tourniquet during ACL surgery affects how well you can see inside the joint, surgery duration, patient pain levels intra-operatively and post-operatively, and speed of quadriceps muscle recovery.
What are the potential side effects?
Potential side effects may include increased pain if a tourniquet is used and delayed muscle function recovery. The exact side effects will be compared between patients with limited or no tourniquet use.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Arthroscopic visibility
IKDC and the Marx Activity Rating Scale scores
Intra-operative opioid requirements
+8 moreOther study objectives
Body Mass Index (BMI)
Ethnicity
Race
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
Patients undergoing patellar bone-tendon-bone autograft ACL reconstruction with a tourniquet used for the duration of the case.
Group II: Treatment/InterventionActive Control1 Intervention
Patients undergoing ACL reconstruction with a tourniquet used only during patellar bone-tendon-bone autograft harvest, for a maximum of 20 minutes.
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Who is running the clinical trial?
OrthoCarolina Research Institute, Inc.Lead Sponsor
35 Previous Clinical Trials
5,962 Total Patients Enrolled
Jonathan Riboh, MDPrincipal InvestigatorOrthoCarolina Research Institute, Inc.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am not adhering to the specific study guidelines for anesthesia, medication, and post-surgery rehab.I am having ACL surgery with a graft from my patellar tendon.I am only having minor knee surgeries along with my main procedure.I have a condition that increases my risk of bleeding.I cannot use epinephrine or TXA due to health reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Treatment/Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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