Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02911909
Study type Interventional
Source University of Missouri-Columbia
Contact
Status Terminated
Phase N/A
Start date October 1, 2017
Completion date October 21, 2019

See also
  Status Clinical Trial Phase
Completed NCT05109871 - Reliability and Validity of Inline Dynamometry Study for Measuring Knee Extensor Torque N/A
Recruiting NCT04088227 - Effects of Platelet Rich Plasma Injections on Biomarkers After Anterior Cruciate Ligament Tears Phase 2
Completed NCT04956393 - The SOAR (Stop OsteoARthritis) Program Proof-of-Concept Study N/A
Recruiting NCT05574946 - Comparison of Two ACL Reconstruction Techniques: All-inside Versus Complete Tibial Tunnel Technique N/A
Completed NCT01447277 - Prospective Femoral Versus Femoral and Sciatic Nerve Block for Anterior Cruciate Ligament (ACL) Reconstruction N/A
Recruiting NCT06430775 - Exploring Prolonged AMR in ACL Reconstructed Patients
Completed NCT02760589 - Magnetic Resonance Imaging and Functional Performance Outcome After ACL Repair With Internal Brace Technique
Completed NCT02787096 - Dynamic Knee Laxity Measurement Coupled to MRI in Cases of Suspected Partial Anterior Cruciate Ligament Tear N/A
Completed NCT04635579 - Personalized Blood Flow Restriction for Anterior Cruciate Ligament Rehabilitation N/A
Completed NCT01850758 - Regenexx™ SD Versus Exercise Therapy for ACL Tears N/A
Recruiting NCT05204836 - Altering Bone Microarchitecture and Mechanics by Off-label Pharmaceutical Intervention Following an Acute Knee Injury Phase 1
Recruiting NCT04592471 - Assessment of the Safety and Performance of Knee Ligament Supports in the Context of a Return to Sport After Sprain
Completed NCT01580722 - Comparison of Early Versus Delay Reconstruction in Anterior Cruciate Ligament Tearing Phase 2
Recruiting NCT05174611 - Vitamin D to Improve Quadricep Muscle Strength Phase 2
Recruiting NCT05501210 - Vibration on Patellofemoral Joint Pain After ACLR N/A
Recruiting NCT05682820 - Analysis of Radiological Features of Lateral Femoral Impaction Fracture / Lateral Femoral Notch Sign
Terminated NCT02930122 - IL-1RA Treatment in Patients With Acute ACL Tear and Painful Effusions Phase 2
Recruiting NCT05306054 - Physical Activity, Knee Joint Loading and Joint Health
Completed NCT04374968 - Use of Blood Flow Restriction Therapy Following ACL Tear N/A
Recruiting NCT04998656 - Werewolf Flow 50 During ACL Reconstruction N/A