Anterior Cruciate Ligament Tear Clinical Trial
Official title:
Moderated Blood Flow Restriction After Anterior Cruciate Ligament
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 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 orthopaedic 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 ROM, KT 2000, Lachman exam, and labs for HGH, IGF, and CK will be
obtained preoperatively. Patients will also complete preoperative IKDC, Tegner, PROMIS, and
VAS pain surveys. Measurements of thigh circumference and knee range of motion will occur at
2 week intervals post operatively. Strength testing will start at 6 weeks 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 month intervals. The study will conclude at 12 month follow up. All
post-operative visits will be standard of care. No additional clinic visits will be required
for this study. Background patient information will be collected including age, sex, BMI, and
co-morbidities.
The control group will be necessary to provide a baseline measure on which moderated blood
flow therapy will be compared.
Blinding of the subject will not be possible as the patient will be able to recognize if they
have or have not had the moderated blood flow (Delfi) device applied during therapy and
application of a sham-device is not practical or considered standard of care. Evaluators
performing measurements will be blinded to the patient's treatment group during assessment of
muscle strength, thigh circumference, knee range of motion, Lachman exam, and KT2000.
Surgeons will also be blinded to the respective treatment groups. All other outcome measures
are objective and quantitative.
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