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Procedure
Graft Tension Techniques for ACL Rupture
N/A
Waitlist Available
Led By Braden C. Fleming, PhD
Research Sponsored by Rhode Island Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Tegner activity score of 5 or greater, indicating participant is at least moderately active
Candidate for ACL reconstruction surgery using a bone-patellar tendon-bone graft or a four-stranded hamstring tendon graft (looped semitendinosus and gracilis muscles)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
Study Summary
This trial will study the long-term effects of different types of ACL reconstruction surgery.
Who is the study for?
This trial is for individuals with a single-knee ACL injury, who are moderately active (Tegner score ≥5), and candidates for ACL reconstruction using specific graft types. Excluded are those with previous knee injuries, certain ligament laxities, arthritis signs, cartilage-damaging diseases, old ACL tears (>12 months), or large meniscal tears.Check my eligibility
What is being tested?
The study investigates the impact of initial graft tension during ACL reconstruction surgery on the development of knee arthritis over a period of at least 15 years. It aims to understand how different tensions applied to the reconstructed ligament influence long-term joint health.See study design
What are the potential side effects?
While not explicitly stated in this summary, potential side effects may include typical surgical risks such as pain, swelling, infection risk at the incision site, blood clots and complications related to anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am moderately active or more, based on the Tegner activity score.
Select...
I am a candidate for ACL surgery using my own knee tendons.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiographic joint space narrowing
Secondary outcome measures
Isokinetic Strength
Knee injury and osteoarthritis outcome score (KOOS)
Knee joint laxity
+6 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Low-tensionExperimental Treatment1 Intervention
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the Low-tension group will receive the low-tension treatment with initial graft tension set so that the anterior-posterior (A-P) displacement of the reconstructed knee is equal to that of the uninjured knee.
Group II: High-tensionExperimental Treatment1 Intervention
Patients recruited to study the initial graft tension during ACL reconstruction surgery who were randomized to the High-tension group will receive the high-tension treatment with the initial graft tension set to reduce A-P displacement by 2 millimeters relative to that of the uninjured knee.
Group III: Uninjured Control GroupActive Control1 Intervention
Uninjured age, sex, and race matched control group
Find a Location
Who is running the clinical trial?
Rhode Island HospitalLead Sponsor
260 Previous Clinical Trials
71,566 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
483 Previous Clinical Trials
1,086,772 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Rupture
270 Patients Enrolled for Anterior Cruciate Ligament Rupture
Braden C. Fleming, PhDPrincipal InvestigatorRhode Island Hospital/Brown Medical School
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am moderately active or more, based on the Tegner activity score.I am a candidate for ACL surgery using my own knee tendons.I do not have conditions like rheumatoid arthritis that risk damaging my joint cartilage.I have moderate knee cartilage damage.You have had a knee injury in the past.One of my knee ligaments is looser than the same ligament in my other knee.You are pregnant.My ACL tear happened over a year ago.I need part of my meniscus removed due to a large tear.I have an ACL injury in one knee with minor meniscal tears.
Research Study Groups:
This trial has the following groups:- Group 1: High-tension
- Group 2: Uninjured Control Group
- Group 3: Low-tension
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the protocol of this trial encompass persons beyond sixty years of age?
"As specified by the study's eligibility requirements, patients must be between 15 and 50 years of age in order to participate."
Answered by AI
Is this research endeavor actively seeking participants?
"Data available on clinicaltrials.gov implies that this study is not open for enrolment at present time, as the last update was made in February 2022. Fortunately, there are presently 95 other trials actively recruiting patients."
Answered by AI
Do I fulfill the requirements for enrollment in this research project?
"This medical experiment requires 168 participants aged between 15 and 50 to have suffered a ruptured ACL. The fundamental criteria for applicants include eligibility for reconstruction surgery with either bone-patellar tendon-bone or four-stranded hamstring tendon grafts, having an activity score of 5+, and only being afflicted in one knee (minor tears up to 1/3 are permissible)."
Answered by AI
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