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Procedure

Graft Choice in ACL Reconstruction Surgery for ACL Rupture

Q: To whom is recruitment for this investigative project available?

This clinical trial is seeking 286 participants who, between ages 14 and 50, have experienced an ACL tear. In addition to meeting this requirement, potential candidates must provide documentation of a prior <a href="https://www.withpower.com/clinical-trials/mri">MRI</a> scan (if the radiologist's report states incomplete or partial ACL but the surgeon diagnoses with complete unilateral tear based on their physical findings then they will still be eligible) as well as details regarding any history of trauma, positive results from Lachman test/anterior drawer test/pivot shift test assessments along with X-rays verifying skeletal maturity and no fractures. Final eligibility will be determined through intraoperative methods.

Q: How many participants are contributing to this research endeavor?

Affirmative. This clinical trial is currently recruiting patients, as evidenced by the information presented on clinicaltrials.gov which shows that it was initially posted on September 11th 2018 and last updated October 14th 2021. To date, 286 individuals are needed to be enrolled from 1 site alone.

Q: Is this research accessible to those under 30 in age?

This trial is recruiting patients aged between 14 and 50. For those who do not meet this criterion, there are 19 studies for minors and 49 specifically targeting seniors.

Q: Are recruitment efforts underway for this clinical investigation?

Affirmative. The information found on clinicaltrials.gov verifies that this medical experiment, which was first published in September 11th 2018, is actively recruiting patients. 286 participants need to be enlisted from 1 location.

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Select...

I am between 14 and 50 years old.

Select...

I have a confirmed tear in my ACL from an injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

graft re-injury (re-rupture, partial tear) or graft failure

Secondary outcome measures

ACL-QOL

Concentric maximal strength

Knee laxity

+3 more

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.

0 / 3Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom is recruitment for this investigative project available?

"This clinical trial is seeking 286 participants who, between ages 14 and 50, have experienced an ACL tear. In addition to meeting this requirement, potential candidates must provide documentation of a prior MRI scan (if the radiologist's report states incomplete or partial ACL but the surgeon diagnoses with complete unilateral tear based on their physical findings then they will still be eligible) as well as details regarding any history of trauma, positive results from Lachman test/anterior drawer test/pivot shift test assessments along with X-rays verifying skeletal maturity and no fractures. Final eligibility will be determined through intraoperative methods."

Answered by AI

How many participants are contributing to this research endeavor?

"Affirmative. This clinical trial is currently recruiting patients, as evidenced by the information presented on clinicaltrials.gov which shows that it was initially posted on September 11th 2018 and last updated October 14th 2021. To date, 286 individuals are needed to be enrolled from 1 site alone."

Answered by AI

Is this research accessible to those under 30 in age?

"This trial is recruiting patients aged between 14 and 50. For those who do not meet this criterion, there are 19 studies for minors and 49 specifically targeting seniors."

Answered by AI

Are recruitment efforts underway for this clinical investigation?

"Affirmative. The information found on clinicaltrials.gov verifies that this medical experiment, which was first published in September 11th 2018, is actively recruiting patients. 286 participants need to be enlisted from 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Number One Overall Graft Pick? Hamstring vs Bone-Patellar-Tendon-Bone vs Quadriceps Tendon

Peter MacDonald 2018. "Number One Overall Graft Pick? Hamstring vs Bone-Patellar-Tendon-Bone vs Quadriceps Tendon". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03671421.