uninflated AirBand for Anterior Cruciate Ligament Reconstruction

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Yale New Haven Hospital, Milford, CT
Anterior Cruciate Ligament Reconstruction
uninflated AirBand - Device
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether blood flow restriction can improve the immune system in people who have had anterior cruciate ligament reconstruction.

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Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether uninflated AirBand will improve 9 primary outcomes and 3 secondary outcomes in patients with Anterior Cruciate Ligament Reconstruction. Measurement will happen over the course of Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise.

Baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise
Change in Leukocyte metabolic gene expression
Change in amino acids concentrations
Change in catecholamines concentrations
Change in creatine kinase
Change in fatty acid concentrations
Change in glucagon concentrations
Change in glucose concentrations
Change in insulin concentrations
Change in lactate concentrations
Change in leukocyte substrate preference
Whether a baseline immunometabolic blueprint predicts the immunometabolic response to resistance training or to BFR.
Whether the immunometabolic response correlates with patient-reported soreness following a physical therapy training session.

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Uninflated Airbnd followed by AirBand
1 of 2
AirBand followed by uninflated AirBand
1 of 2
Experimental Treatment

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Uninflated AirBand is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Uninflated Airbnd followed by AirBandThe order of study days will be randomized. participants will wear an uninflated AirBand as the control intervention during the session in which BFR is not performed,
AirBand followed by uninflated AirBandThe order of study days will be randomized. participants will wear an uninflated AirBand as the control intervention during the session in which BFR is not performed,

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 0 (immediately at the end of the exercise session), 30, and 60 minutes post exercise for reporting.

Closest Location

Yale New Haven Hospital - Milford, CT

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
All genders, between 18 and 60 years of age
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for two study visits at least 1 week apart
In good general health without any underlying medical conditions or prior injury that would place the subject at risk of further injury/illness by participating in the study

Patient Q&A Section

What is uninflated airband?

"The uninflated airband is an effective means of achieving a low postoperative knee range of motion in patients undergoing a primary anterior cruciate ligament reconstruction." - Anonymous Online Contributor

Unverified Answer

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

"Each year, ACLR is performed on around 1.8 million men and women in the US. This makes up an average of one per every 678 citizens." - Anonymous Online Contributor

Unverified Answer

What is anterior cruciate ligament reconstruction?

"The ACL is a strong and well-suited ligament with a high degree of healing potential. However, due to the high load placed on the reconstructed ACL, the chances of failure are high and the time interval for obtaining an ACL graft is long. Furthermore, reconstruction surgery has a higher risk in younger patients, where the physical growth of the reconstructed graft is hindered by the reconstructed knee structure. Therefore, an ACL reconstruction should only be considered if the surgeon is sure of sufficient bone strength and adequate growth potential. The objective should be a reconstruction with a graft from the tibia. For a minimally invasive procedure with good postoperative results, preoperative treatment, especially hormonal injection and physiotherapy, must commence as early as possible." - Anonymous Online Contributor

Unverified Answer

What are common treatments for anterior cruciate ligament reconstruction?

"For ACL reconstruction it is important to focus less on the type of surgery and more on the recovery rate, so as to achieve the best clinical outcome." - Anonymous Online Contributor

Unverified Answer

What causes anterior cruciate ligament reconstruction?

"It appears that ACL injury is the major cause of anterior cruciate ligament reconstruction, with concomitant knee and hip pathology being almost certainly a factor but probably not the only cause. However, the knee-meniscectomy-injury subgroup is almost certainly the result of both factors. This research has the implications of avoiding knee surgery, and the possibility of early reconstruction." - Anonymous Online Contributor

Unverified Answer

Can anterior cruciate ligament reconstruction be cured?

"We did not find evidence of a clear association between ACL reconstruction and improvement of function. However, the high level of subjective recovery of function, the low number of patients who had no improvement of function, and the absence of difference between graft types made general conclusions difficult. Findings from a recent study do not permit conclusions on the efficacy of ACL reconstruction and the ability of ACL reconstruction to cure functional outcome." - Anonymous Online Contributor

Unverified Answer

What are the signs of anterior cruciate ligament reconstruction?

"These include instability of the knee and swelling in the thigh. The knee may show involuntary movements or involuntary movements after physical activity or following passive movements of the knee (i.e. when standing up). Swelling in the thigh joint may occur. Tenderness at the iliac crest may occur. Pain may be felt to the tibia. Symptoms from the surgery are swelling, pain, and swelling. These may last for over one month following surgery. There are no specific tests that will diagnose anterior cruciate ligament reconstruction.\n\nIn children, the following signs of an upper respiratory infection are not signs of arthritis or OA." - Anonymous Online Contributor

Unverified Answer

Does uninflated airband improve quality of life for those with anterior cruciate ligament reconstruction?

"Data from a recent study demonstrate statistically significant, statistically significant short-term improvement in the physical-as well as psychological-dimensions of HRQOL in ACUR group. Therefore, we conclude that using UAB as a noninvasive treatment may lead to short-term benefit of HRQOL in ACL Reconstruction. Further studies are needed to determine the long-term improvement and the best time to use UAB for ACL Reconstruction. Data from a recent study does not refute the idea that there would be benefit by using UAB in ACL Reconstruction to improve short-term HRQOL of ACL-reconstruction patients. The difference with this study might be that the number of patients and/or severity of patients in our study." - Anonymous Online Contributor

Unverified Answer

What does uninflated airband usually treat?

"Findings from a recent study suggest that with proper technique and rehabilitation, a torn ACL can heal and improve function with appropriate rehabilitation. Airband may lead to poorer functional recovery than conventional treatment. However, the results of the current study showed the positive effects of the airband on muscle, and the overall benefits of the standard treatment outweighed those of the airband." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for anterior cruciate ligament reconstruction?

"Physicians prescribing ACLR should consider clinical trials for patients>=20 years. Patients should not be excluded from clinical trials on the basis of age alone. Younger patients, however, should be excluded in the context of a clinical trial for patients<20 years." - Anonymous Online Contributor

Unverified Answer

Is uninflated airband typically used in combination with any other treatments?

"UAB is not an ideal material to use in the treatment of patients with ACL injuries. Given the wide range of methods that have been used to reconstruct ACL with UAB, these data suggest that UAB is an inappropriate treatment option unless an explanation can be drawn from existing literature to suggest that another method might be more effective." - Anonymous Online Contributor

Unverified Answer

How does uninflated airband work?

"There was no significant difference between the uninflated airband with saline and the conventional pressure-controlled ACL reconstruction in terms of graft remodelling, graft contraction, and clinical results at one-year postoperative. Therefore, uninflated airband used alone for ACL reconstruction is a viable option." - Anonymous Online Contributor

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