Moderated Blood Flow Restriction After Anterior Cruciate Ligament Reconstruction

Moderated Blood Flow Restriction After Anterior Cruciate Ligament

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02911909

Acronym

Delfi

Enrollment

Registered

2016-09-22

Start date

2017-10-01

Completion date

2019-10-21

Last updated

2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Tear

Brief 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.

Detailed 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.

Interventions

DEVICEDelfi

Patients will receive standard of care post-operative ACL reconstruction rehabilitation plus the Delfi moderated blood flow restriction therapy.

OTHERStandard rehabilitation

Patients will receive standard of care post-operative ACL reconstruction rehabilitation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 30 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Muscle Strength	12 months	Compare mean peak muscle strength at 60 degrees of knee flexion (during extension) of the involved leg between the blood restriction and the control groups

Secondary

Measure	Time frame	Description
Tegner Activity Survey Score	12 months	Compare the Tegner Activity Survey score mean between the Delfi and the control group. Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. The score varies from 0-10. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports \>6 score can only be achieved if the person participates in recreational or competitive sport.
Patient-Reported Outcomes Measurement Information System (PROMIS) Survey Score.	12 months	Compare the mean Patient-Reported Outcomes Measurement Information System Global Physical health row score (PROMIS) between the Delfi and the control group. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. The Score is represented in a 0 to 100 scale. Zero is the worst possible outcome and 100 is teh best possible outcome
International Knee Documentation Committee (IKDC) Survey Score	12 months	Compare the mean International Knee Documentation Committee (IKDC) survey score between the delfi and the control group The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee. Meanwhile, the sports activity subscale focuses on functions like going up and down the stairs, rising from a chair, squatting and jumping. The knee function subscale asks patients one simple question: how is their knee at present versus how was their knee prior to injury? Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
Visual Analog Scale (VAS)	12 months	Compare the mean VAS scores (0 no pain - 10 worse pain ever) between the Delfi and the control group
Range of Motion	12 months	Compare the total Range of motion of the involved leg at 12 months between the Delfi and the control group
KT-2000 Anterior Tibial Translation	12 months	Compare the mean anterior translation of the tibia between delfi and control groups anterior translation was measured using a KT-2000 device
CK Level	12 months	Compare CK levels at 12 months between delfi and control group
HGH Level	12 months	Compare mean HGH blood levels between the delfi and the control group
IGF Level	12 months	Compare the mean IGF blood values between delfi and control group
Tight Circumference	12 months	Compare tight circumference of the involved leg between Delfi and the control group

Countries

United States

Participant flow

Participants by arm

Arm	Count
Standard Rehabilitation Patients will receive standard post-operative ACL rehabilitation Standard rehabilitation: Patients will receive standard of care post-operative ACL reconstruction rehabilitation	2
Delfi Moderated Blood Flow Restriction Patients will receive Delfi moderated blood flow post-operative ACL rehabilitation Delfi: Patients will receive standard of care post-operative ACL reconstruction rehabilitation plus the Delfi moderated blood flow restriction therapy.	0
Total	2

Baseline characteristics

Characteristic	Total	Standard Rehabilitation
Age, Continuous	29.5 years STANDARD_DEVIATION 1.5	29.5 years STANDARD_DEVIATION 1.5
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants
Race (NIH/OMB) White	2 Participants	2 Participants
Sex: Female, Male Female	1 Participants	1 Participants
Sex: Female, Male Male	1 Participants	1 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 2	0 / 0
other Total, other adverse events	0 / 2	0 / 0
serious Total, serious adverse events	0 / 2	0 / 0

Outcome results

Primary

Muscle Strength

Compare mean peak muscle strength at 60 degrees of knee flexion (during extension) of the involved leg between the blood restriction and the control groups

Time frame: 12 months

Population: No Subjects in the Deflfi group completed the muscle strength evaluation at 12 months

Arm	Measure	Value (MEAN)	Dispersion
Standard Rehabilitation	Muscle Strength	95.5 FT-LBS	Standard Deviation 60.7

Secondary

CK Level

Compare CK levels at 12 months between delfi and control group

Time frame: 12 months

Population: Samples were not processed due to study termination

Secondary

HGH Level

Compare mean HGH blood levels between the delfi and the control group

Time frame: 12 months

Population: Samples were not processed due to study termination

Secondary

IGF Level

Compare the mean IGF blood values between delfi and control group

Time frame: 12 months

Population: samples were not processed due to study termination

Secondary

International Knee Documentation Committee (IKDC) Survey Score

Compare the mean International Knee Documentation Committee (IKDC) survey score between the delfi and the control group The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee. Meanwhile, the sports activity subscale focuses on functions like going up and down the stairs, rising from a chair, squatting and jumping. The knee function subscale asks patients one simple question: how is their knee at present versus how was their knee prior to injury? Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.

Time frame: 12 months