Moderated Blood Flow Restriction After Anterior Cruciate Ligament Reconstruction

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.

Inclusion Criteria:

- Patients between 18-30 years of age.

- Diagnosis of isolated anterior cruciate ligament (ACL) tear and pending ACL
reconstruction.

Exclusion Criteria:

- age <18 years old or >30 years old

- Multi-ligament knee injury

- Revision ACL reconstruction

- History or peripheral vascular disease

- History of deep vein thrombosis or pulmonary embolism

- Any contraindication to moderated blood flow restriction therapy

- Inability to comply with post-operative ACL reconstruction rehabilitation

- If meniscal repair or a cartilage procedure is performed at the time of surgery that
would preclude the patient from being able to follow the standard post-operative ACL
rehabilitation.