CLINICAL TRIAL

Blood Flow Restriction Therapy for Rupture

Recruiting · < 65 · All Sexes · Fairfax, VA

This study is evaluating whether a new therapy may help improve recovery from ACL surgery.

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About the trial for Rupture

Eligible Conditions
Rupture · Anterior Cruciate Ligament Rupture

Treatment Groups

This trial involves 2 different treatments. Blood Flow Restriction Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Blood Flow Restriction Therapy
DEVICE
ACL Reconstruction rehabilitation
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
ACL Reconstruction rehabilitation
OTHER

Eligibility

This trial is for patients born any sex aged 65 and younger. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
ACL reconstruction
If you're in need of physical therapy, consider a center with Blood Flow Restriction capabilities show original
You're eligible for surgery if you're between the ages of 13 and 35. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Measured at 2,4,6,12 weeks and 6, 12, and 24 months post op
Screening: ~3 weeks
Treatment: Varies
Reporting: Measured at 2,4,6,12 weeks and 6, 12, and 24 months post op
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Measured at 2,4,6,12 weeks and 6, 12, and 24 months post op.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Blood Flow Restriction Therapy will improve 4 primary outcomes and 1 secondary outcome in patients with Rupture. Measurement will happen over the course of Tracked from initiation of therapy 2 weeks post-op through 16 weeks post-op.

Adverse Effects
TRACKED FROM INITIATION OF THERAPY 2 WEEKS POST-OP THROUGH 16 WEEKS POST-OP
Observation of any adverse events associated with BFR therapy, such as numbness, cuff-site pain, and bruising.
TRACKED FROM INITIATION OF THERAPY 2 WEEKS POST-OP THROUGH 16 WEEKS POST-OP
Quadriceps Tendon Strength
MEASURED WEEKLY UP TO 16 WEEKS AND THEN AT 6 MONTHS.
We will measure quadriceps tendon strength (closed chain) strength using a dynamometer.
MEASURED WEEKLY UP TO 16 WEEKS AND THEN AT 6 MONTHS.
Thigh Circumference
MEASURED WEEKLY UP TO 16 WEEKS AND THEN AT 6 MONTHS.
A tape measure will be used to measure the thigh circumference 15 cm proximal to the superior pole of the patella
MEASURED WEEKLY UP TO 16 WEEKS AND THEN AT 6 MONTHS.
International Knee Documentation Committee (IKDC)
MEASURED AT 3, 6, 12, 24 MONTHS POST OP
The International Knee Documentation Committee (IKDC Questionnaire) is a knee-specific patient-reported outcome measure. The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
MEASURED AT 3, 6, 12, 24 MONTHS POST OP
Visual Analog Score
MEASURED AT 2,4,6,12 WEEKS AND 6, 12, AND 24 MONTHS POST OP
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
MEASURED AT 2,4,6,12 WEEKS AND 6, 12, AND 24 MONTHS POST OP

Who is running the study

Principal Investigator
E. C.
Edward Chang, MD
Inova Health Care Services

Patient Q & A Section

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

Can rupture be cured?

Rupture can occur in the absence of a benign condition. In the absence of complications, a peritoneal lavage should always occur; this leads to an improvement or a stabilization of the symptoms. If the symptoms recur, a thorough surgical operation is needed to determine the surgical strategy. We report for the first time in the literature a case of a healed peritoneum after a peritoneal lavage of a perforated left hepatic colic. This case is the first to illustrate the impact of the perforation on the immune system and to show that a peritoneal lavage in the event of a perforation is curative.

Anonymous Patient Answer

What are common treatments for rupture?

Surgery is the most common treatment for ruptured intracranial aneurysms. Treatment depends on the patient's condition at the time of rupture, the site of the aneurysm, the extent of brain injury, and whether a subarachnoid hemorrhage has occurred. If an aneurysm ruptures and causes a subarachnoid hemorrhage, medical specialists might treat the aneurysm with medications or by breaking it into smaller pieces. However, surgery often needs to be performed.

Anonymous Patient Answer

How many people get rupture a year in the United States?

About 2 percent of Americans (6% of those younger than 60 years old) suffered a ruptured benign aneurysm due to arterial thrombosis as of 2001. Most cases were diagnosed between the second trimester of pregnancy and one month postpartum. This has changed little in the last 10 years, despite widespread awareness of the condition.

Anonymous Patient Answer

What are the signs of rupture?

When examining people at risk of rupture, the clinical examination of a person with hip fracture, particularly of the iliopsoas muscle, is essential to pinpoint the presence of an occult or unsuspected ruptured aortic aneurysm.

Anonymous Patient Answer

What causes rupture?

Rupture of an aneurysm is usually caused by a sudden burst of blood from one of the aneurysms. However, this can occur suddenly when the wall of the aneurysm is weak. Rarely, rupture is caused by a tumour in the aneurysm wall, but this is much less common. Any combination of factors can ultimately induce a rupture, including a tumour, enlargement of the aneurysm or other problems with the blood vessels supplying the aneurysm such as stenosis or atherosclerosis.

Anonymous Patient Answer

What is rupture?

Routine radiographic assessment at 3 months for patients with suspected fracture following abdominal trauma is unnecessary. Failure to do so may lead to an unnecessarily prolonged hospital stay and to excessive use of CT scans.

Anonymous Patient Answer

Has blood flow restriction therapy proven to be more effective than a placebo?

The use of high intensities of BFR therapy in this population of women with pelvic pain has been well accepted by the patients. No significant differences emerged in pelvic pain symptomatology, uterine blood flow, and uterine contractility between BFR and placebo groups, supporting the effectiveness of BFR therapy.

Anonymous Patient Answer

Have there been other clinical trials involving blood flow restriction therapy?

This new medical treatment has been tested on a variety of different patient groups, all with varying success. Findings from a recent study of another large randomized controlled trial are awaited.

Anonymous Patient Answer

Have there been any new discoveries for treating rupture?

Until now, we know that the blood clot is very hard, and there are no effective solutions for it. However, we also know that there are some medicines that can treat it, but many of them take long-term treatment to work. It seems that the best way is using all the treatments together to treat the ruptured aneurysm.

Anonymous Patient Answer

Who should consider clinical trials for rupture?

For clinical trials that specifically use participants who have had a rupture of a blood vessel, you should consider the potential benefits and harms of immunotherapy.

Anonymous Patient Answer

What is the average age someone gets rupture?

The average age of a rupture is 66 yrs old, and most people are male. Most patients were unemployed and their marital status did not change following a slip or fall. The majority of patients lived in a rural setting and were not involved in some type of sporting activity. The majority of patients were discharged Home from the Accident and Emergency following slip or fall events from a private residence and not hospital or from an ED. The patient-directed pre-injury information programme in the last two months before the incident may have helped in decreasing the number of patient expectations in this high-risk population.

Anonymous Patient Answer

Is blood flow restriction therapy typically used in combination with any other treatments?

There is a tendency to apply a specific therapeutic option according to the type of bleeding. This is a result of the particular bleeding type, as indicated by high bleeding activity such as esophageal or intestinal bleeding, and lower activity bleeding in other areas. The treatment method used in specific bleeding lesions differs from each other. Blood flow restriction therapy is typically used in conjunction with other treatment options, such as antiplatelet agents or hemostatic devices with a lower efficiency than blood flow restriction therapy.

Anonymous Patient Answer
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