Moderated Blood Flow Restriction After Anterior Cruciate Ligament Reconstruction

2016-09-22 20:53:21 | BioPortfolio


The aim of this study is to determine if there is a difference in post operative rehabilitation after anterior cruciate ligament (ACL) reconstruction surgery while using moderated blood flow therapy vs. standard physical therapy. All patients undergoing ACL reconstruction, between the ages of 18-30, that consent to taking part in the study, and meet eligibility criteria, will be included in the study. Patients will be followed for two years to determine any differences in muscle strength, thigh circumference, knee range of motion, pain, functional and activity levels, patient satisfaction, levels of Human growth hormone HGH), Insulin-like Growth Factor (IGF), and Creatine Kinase (CK), KT2000, and Lachman physical examination.


The study will be a prospective, randomized, controlled trial between two treatment cohorts. A total of 50 patients will be enrolled in the study. Informed consent will be obtained in clinic prior to any surgical intervention, per the Institutional Review Board (IRB) protocol. Enrollees will receive a copy of the consent and HIPAA form. All patients that meet inclusion criteria who consent to participate in the study will then be randomly assigned to either the control group or moderated blood flow therapy group. Randomization will occur by autogenerated permutated 1:1 block randomization using electronic assignment from the orthopedic research team prior to initiation of post-operative therapy. The control group will undergo standard of care, post-operative ACL reconstruction rehabilitation. The treatment group will also receive standard ACL rehabilitation combined with Delfi moderated blood flow restriction therapy. Patients will follow up at standard of care clinic visits and participate in the same standard of care physical therapy protocol for ACL reconstruction. Baseline measurements of thigh circumference, knee range of motion (ROM), KT 2000, Lachman exam, and labs for HGH, IGF, and CK will be obtained preoperatively. Patients will also complete preoperative International Knee Documentation Committee (IKDC), Tegner, and PROMIS surveys, and a Visual Analog Pain Scale (VAS). Measurements of thigh circumference, strength, and knee range of motion will occur at 2 week intervals post-operatively. These measurements will occur during standard therapy sessions. KT 2000 and Lachman exam will be performed at 4, 6, 8, and 12 months post-operatively. A standard functional return to sport evaluation will be performed at the 4, 6, 8, and 12 month postoperative visits. Labs for HGH, IGF, and CK will be drawn at 2, 6, 12, and 24 weeks. VAS pain scores will be recorded before and after each therapy session. The PROMIS, IKDC, and Tegner surveys will be given at 4, 6, 8, 12, 24 month intervals. The study will conclude at 24 month follow up.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Anterior Cruciate Ligament Tear


Delfi, Standard rehabilitation


Missouri Orthopaedic Institute
United States


Not yet recruiting


University of Missouri-Columbia

Results (where available)

View Results


Published on BioPortfolio: 2016-09-22T20:53:21-0400

Clinical Trials [882 Associated Clinical Trials listed on BioPortfolio]

French Prospective Anterior Cruciate Ligament Reconstruction Cohort Study (FAST)

In this study we will examine patients who have undergone anterior cruciate and/or posterior cruciate ligament and/or multi ligaments reconstruction to determine the rate of re-injury, con...

Dynamic Knee Laxity Measurement Coupled to MRI in Cases of Suspected Partial Anterior Cruciate Ligament Tear

Anterior cruciate ligament (ACL) tear is frequent, but the diagnosis of partial tears is difficult. Standard MRI may be used but is of limited diagnostic value. The present study aimed to ...

Comparison of Remnant Preserving Versus Remnant Resecting Anterior Cruciate Ligament Reconstruction

Anterior cruciate ligament injury is very common knee injury. Especially Anterior cruciate ligament complete rupture leads to knee joint instability and degenerative change of the knee. An...

Reconstruction of the Anterolateral Ligament (ALL) With Revision Anterior Cruciate Ligament (ACL) Surgery

Patients with combined Anterolateral ligament (ALL) reconstruction- Anterior cruciate ligament (ACL) revision will have a better rotational knee stability and therefore better patient repo...

Anterior Cruciate Ligament Rupture

The assess results of Anterior Cruciate Ligament (ACL) repair with the Ligamys® surgical technique versus standard technique. The aim of the study is to compare (laxity, instability, and...

PubMed Articles [9375 Associated PubMed Articles listed on BioPortfolio]

How to evaluate precisely return to sport after anterior cruciate ligament tear with operative or conservative treatment on patients with moderate sport level?

Several ways exist to assess return to sport (RTS) after anterior cruciate ligament tear (ACLT): main sport or anterior level, pivoting contact sports or competition. Performing a relevant evaluation ...

An In Vitro Robotic Assessment of the Anterolateral Ligament, Part 1: Secondary Role of the Anterolateral Ligament in the Setting of an Anterior Cruciate Ligament Injury.

Recent investigations have described the structural and functional behavior of the anterolateral ligament (ALL) of the knee through pull-apart and isolated sectioning studies. However, the secondary s...

Return to Play Following Anterior Cruciate Ligament Reconstruction.

Anterior cruciate ligament reconstructions are commonly performed in an attempt to return an athlete to sports activities. Accelerated rehabilitation has made recovery for surgery more predictable and...

Evolution of the anteroposterior laxity by GnRB at 6, 9 and 12 months post-surgical anterior cruciate ligament reconstruction.

This study aimed to analyze the evolution of the tibiofemoral anterior laxity during the return to sport after anterior cruciate ligament reconstruction.

Rehabilitation Following Anterior Cruciate Ligament Tears in Children: A Systematic Review.

Anterior cruciate ligament (ACL) tears are increasingly prevalent in the pediatric population. ACL rehabilitation is an essential component of recovery following injury and reconstruction, yet there a...

Medical and Biotech [MESH] Definitions

A strong ligament of the knee that originates from the posteromedial portion of the lateral condyle of the femur, passes anteriorly and inferiorly between the condyles, and attaches to the depression in front of the intercondylar eminence of the tibia.

A strong ligament of the knee that originates from the anterolateral surface of the medial condyle of the femur, passes posteriorly and inferiorly between the condyles, and attaches to the posterior intercondylar area of the tibia.

There are two lateral ligaments of the ankle - internal and external. The internal lateral ligament is attached to the apex and anterior and posterior bodies of the inner malleolus and inserted into the navicular bone, the inferior calcaneo-navicular ligament, the sustentaculum tali of the os calcis, and the inner side of the astragalus. The external lateral ligament, also called the lateral collateral ligament, consists of three distinct fasciculi - the calcaneofibular, the anterior talofibular, and the posterior talofibular.

Measurements of joint flexibility (RANGE OF MOTION, ARTICULAR), usually by employing an angle-measuring device (arthrometer). Arthrometry is used to measure ligamentous laxity and stability. It is often used to evaluate the outcome of ANTERIOR CRUCIATE LIGAMENT replacement surgery.

Fixation of the ANTERIOR CRUCIATE LIGAMENT, during surgical reconstruction, by the use of a bone- patellar tendon autograft.

More From BioPortfolio on "Moderated Blood Flow Restriction After Anterior Cruciate Ligament Reconstruction"

Quick Search

Relevant Topics

Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...

Joint Disorders
A joint is where two or more bones come together, like the knee, hip, elbow, or shoulder. Joints can be damaged by many types of injuries or diseases, including Arthritis - inflammation of a joint causes pain, stiffness, and swelling with ...

Searches Linking to this Trial