Patients will be randomized into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone. for Anterior Cruciate Ligament Tear

Phase-Based Estimates
1
Effectiveness
1
Safety
Lurie Children's Hospital, Chicago, IL
Anterior Cruciate Ligament Tear+2 More
Patients will be randomized into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone. - Procedure
Eligibility
< 65
All Sexes
Eligible conditions
Anterior Cruciate Ligament Tear

Study Summary

This study is evaluating whether a surgery to repair a torn anterior cruciate ligament (ACL) may also help repair a torn anterior cruciate ligament (ACL) in

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Eligible Conditions

  • Anterior Cruciate Ligament Tear
  • Anterior Cruciate Ligament Injuries
  • ACL Tears
  • ACL Injury

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Patients will be randomized into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone. will improve 1 primary outcome and 2 secondary outcomes in patients with Anterior Cruciate Ligament Tear. Measurement will happen over the course of Complete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years..

Year 5
Complications of ALL reconstruction
Graft failure
Patient reported outcome measures

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

No Control Group
Concomitant ACL and ALL reconstruction

This trial requires 720 total participants across 2 different treatment groups

This trial involves 2 different treatments. Patients Will Be Randomized Into One Of Two Study Arms: (1) Concomitant ACL And ALL Reconstruction Or (2) ACL Reconstruction Alone. is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Concomitant ACL and ALL reconstruction
Procedure
The participant will undergo both the ACL and ALL reconstruction surgery.
ACL reconstruction alone
Procedure
The participant will undergo only ACL reconstruction surgery.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: complete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly complete when all 780 participants have been recruited, received an intervention and have been followed for data collection for up to 5 years. for reporting.

Who is running the study

Principal Investigator
N. P.
Neeraj Patel, MD
Ann & Robert H Lurie Children's Hospital of Chicago

Closest Location

Lurie Children's Hospital - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 18 and under
did not improve shoulder function Surgery within 6 months of injury did not improve shoulder function compared to those who did not have surgery. show original
If you have never had an ACL injury or surgery, you can still have a primary ACL reconstruction. show original
Autograft ACL reconstruction
Closing or closed physes

Patient Q&A Section

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

What are the signs of anterior cruciate ligament tear?

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A positive anteroposterior tibial translation of greater than 5 cm is the key sign or "red flag" for an ACL-injured knee. A negative tibial pivot sign on the symptomatic knee signifies a normal or non-injured ACL. Patients with positive anteroposterior tibial translations usually (68%) have concurrent meniscal tears and knee instability.

Unverified Answer

Can anterior cruciate ligament tear be cured?

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Despite evidence of spontaneous healing of the anterior cruciate ligament rupture, these patients, who present with the symptoms of the acute injury in the mid-range of the usual severity spectrum, continue to have significant knee symptoms at 1-year follow-up. However, they report an overall improvement of their quality of life. There is a trend to good clinical outcomes with respect to knee function when compared to previously published results for the acutely injured and the delayed ACL injury group; this could be due to earlier presentation of these patients with the chronic injury and thus perhaps to greater likelihood of spontaneous healing of the injury.

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What are common treatments for anterior cruciate ligament tear?

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There is no significant difference in outcomes between the different ACL reconstruction procedures; however, surgeons will most likely offer different rehabilitation protocols and offer knee stability exercises before people are given a surgery choice.

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How many people get anterior cruciate ligament tear a year in the United States?

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About 4.7 million American adults suffer an anterior cruciate ligament tear. This corresponds to an incidence of 20% of all the ACL injuries; it might be the most common injury in American females.

Unverified Answer

What causes anterior cruciate ligament tear?

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ACL tear is due to a combination of mechanical, physiological, and pathological factors. A better understanding of these factors is needed for a better assessment of the etiology of ACL injury and to reduce the incidence of injuries in this area of the knee.

Unverified Answer

What is anterior cruciate ligament tear?

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Anterior cruciate ligament tear occurs most commonly in athletes and is typically associated with an injury to the knee during pivot activities such as a high, valgus or external rotation in conjunction with the pivot landing. Injury patterns vary among athletes and different knee biomechanical stresses can lead to different patterns of tearing. As a result, the precise mechanism for injury and its associated tears are not known. Many times, the tears can be diagnosed based on an abnormal clinical exam. However, the lack of a physical examination and the low sensitivity of a clinical exam to objectively ascertain the exact degree of injury, has made a diagnosis in the first instance challenging.

Unverified Answer

Does anterior cruciate ligament tear run in families?

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Recent findings demonstrate that people with a first-degree relative with anterior cruciate ligament injury also are at increased risk of sustaining an injury, and a higher proportion than the risk for sporadic anterior cruciate ligament injuries. Individuals with a familial tendency to anterior cruciate ligament injury should undergo closer surveillance to better evaluate the need for surgery.

Unverified Answer

Have there been other clinical trials involving patients will be randomized into one of two study arms: (1) concomitant acl and all reconstruction or (2) acl reconstruction alone.?

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There are no previously published trials regarding concomitant acl and knee reconstruction. To our knowledge, this is the first study to our knowledge to describe the use and outcomes of this complex concomitant knee reconstruction surgery. The data collected from this study should influence the surgeon as well as the patient who will be treated with this procedure in the future. ClinicalTrials.gov identifier: NCT03120530.

Unverified Answer

Has patients will be randomized into one of two study arms: (1) concomitant acl and all reconstruction or (2) acl reconstruction alone. proven to be more effective than a placebo?

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One randomized controlled study (the ACRL study). Compared the safety, functional outcome and knee radiographs between ACL reconstruction and a composite ACL reconstruction with simultaneous reconstruction of the meniscus. Findings are that the ACL reconstruction with concomitant meniscus replacement showed no difference in functional outcomes and knee osteoarthritic change over time, but the ACL reconstruction alone yielded no difference in the radiographic knee osteoarthritis improvement over 5 years. However, it was only one randomized controlled study. There are potential for bias. Additional study is underway to compare the ACL reconstruction with a knee reconstruction and meniscus.

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What is the primary cause of anterior cruciate ligament tear?

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Among patients who were injured during sporting activities, ACL tears were typically caused by a valgus force (23%) or a combined valgus and femoral external rotation force (60%). There was also a high coincidence with the occurrence of a prior ACL injury.

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What are the latest developments in patients will be randomized into one of two study arms: (1) concomitant acl and all reconstruction or (2) acl reconstruction alone. for therapeutic use?

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Recent findings provides evidence that the use of an all reconstruction technique, as compared with acl rupture alone when used for therapeutic purposes, did not lead to improved clinical, functional, or imaging outcomes at 12 months.

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What is patients will be randomized into one of two study arms: (1) concomitant acl and all reconstruction or (2) acl reconstruction alone.?

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The current study has demonstrated significant and statistically meaningful improvement in function after reconstructive surgery, while highlighting significant differences in function, in both patient-reported and functional limitation, post-operatively. While this is a single institution retrospective study, this is the first detailed account of the clinical and radiological outcomes of concomitant acl augmentation with reconstruction in hip arthroscopy.

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