Table 1.
Inclusion and Exclusion Criteria for Entrance Into the BFRT Clinical Trial for Patients With ACL Injurya
| Inclusion Criteria |
|---|
| Male or female (15–40 years of age); must be skeletally mature with closed physes |
| Diagnosis of ACL tear with planned surgery confirmed via clinical examination and MRI within the past 8–10 weeks |
| No previous ACL injury or reconstruction on either the involved limb or noninvolved limb |
| At least a 5/10 on the Tegner Activity Scale |
| Pass the PARQ questionnaire with the exception of question 5, “Do you have a bone or joint problem?”, because the participant pool being recruited for this study will have an ACL tear and having this injury does not change the risk for the participant |
| Exclusion Criteria |
| Complete knee dislocation |
| Surgical management requiring repair of other structures within the knee other than the ACL and menisci (such as PCL, MCL, LCL) |
| Any current or previous conditions or surgeries that might affect gait |
| Body mass index ≥35 |
| Pregnant |
| Spinal fusion |
| Any implanted medical device or other contraindication for MRI |
| History of deep vein thrombosis and/or varicose veins or family history of deep vein thrombosis |
| Taking Warfarin/Coumadin, Clopidogrel/Plavix, Rivaroxabn/Xarelto, Dabigatran/Pradaxa, Apixaban/Eliguis, Edoxaban/Savaysa, Betrixaban, or any other anti-coagulant that may cause excess bleeding |
| Allergic to Betadine or Xylocaine HCl |
| Recent inflammation, bleeding disorders, active bleeding, or infection within the lower limbs |
| Diabetic or have uncontrolled hypertension |
| Diminished capacity to provide informed consent |
| Unfeasible to attend regular physical therapy and study visits |
ACL = anterior cruciate ligament; BFRT = blood flow restriction training; HCl = hydrochloride; LCL = lateral collateral ligament; MCL = medial collateral ligament; MRI = magnetic resonance imaging; PARQ = physical activity readiness questionnaire; PCL = posterior cruciate ligament.