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Procedure

Graft Choice in ACL Reconstruction Surgery for ACL Rupture

N/A
Waitlist Available
Research Sponsored by Panam Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
X-rays showing skeletal maturity and no fractures
Patients must be 14 to </= 50 years (at time of surgery)
Must not have
Confirmed connective tissue disorder
Unwillingness to be followed for 24 months post-operatively
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying whether one of three types of ACL reconstruction surgery is better than the others at preventing re-injury and improving quality of life.

Who is the study for?
This trial is for individuals aged 14 to 50 with a confirmed diagnosis of a complete primary unilateral ACL rupture, based on injury history, physical exams, and MRI. They must have mature skeletons without fractures and be willing to follow up for two years post-surgery. Exclusions include previous ACL injuries on the other limb, certain ligament tears requiring surgery, severe knee cartilage damage, pregnancy, inability to understand English or give informed consent.
What is being tested?
The study aims to compare re-injury rates and patient outcomes after an Anterior Cruciate Ligament (ACL) reconstruction using one of three different grafts: hamstring tendon (STG), bone-patellar-tendon-bone (BPTB), or quadriceps tendon (QT). It will also assess quality of life and functional performance following the surgery.
What are the potential side effects?
While not explicitly stated in the provided information, common side effects from ACL reconstruction can include pain at the graft site, swelling around the knee joint area, limited range of motion temporarily after surgery and potential risk for infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My X-rays show fully developed bones with no breaks.
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I am between 14 and 50 years old.
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I have a confirmed tear in my ACL from an injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a diagnosed connective tissue disorder.
Select...
I am not willing to have follow-up visits for 24 months after surgery.
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I do not have a major illness that would give me less than a year to live.
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My knee cartilage damage is severe, confirmed during surgery.
Select...
I had ACL reconstruction with donor tissue.
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I have a history of rheumatoid arthritis.
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I need surgery for a torn ligament in my knee.
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I have a torn ACL in the opposite limb.
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My ACL is partially torn, confirmed during surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
graft re-injury (re-rupture, partial tear) or graft failure
Secondary study objectives
Concentric maximal strength
Knee laxity
Pain log

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: Quads tendonActive Control1 Intervention
The graft tissue will be quadriceps tendon
Group II: HamstringActive Control1 Intervention
Semitendinosus and gracilis will be used for graft
Group III: BPTBActive Control1 Intervention
Bone patellar tendon bone graft to be used.

Find a Location

Who is running the clinical trial?

Panam ClinicLead Sponsor
16 Previous Clinical Trials
1,208 Total Patients Enrolled

Media Library

ACL reconstruction - graft choice (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03671421 — N/A
Anterior Cruciate Ligament Rupture Research Study Groups: Quads tendon, Hamstring, BPTB
Anterior Cruciate Ligament Rupture Clinical Trial 2023: ACL reconstruction - graft choice Highlights & Side Effects. Trial Name: NCT03671421 — N/A
ACL reconstruction - graft choice (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03671421 — N/A
~41 spots leftby Dec 2025
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