Moderated Blood Flow Restriction After Anterior Cruciate Ligament Reconstruction (Delfi)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02911909|
Recruitment Status : Terminated (Recruitment was unsuccessful)
First Posted : September 22, 2016
Results First Posted : March 11, 2020
Last Update Posted : March 11, 2020
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Anterior Cruciate Ligament Tear||Device: Delfi Other: Standard rehabilitation||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Moderated Blood Flow Restriction After Anterior Cruciate Ligament|
|Actual Study Start Date :||October 1, 2017|
|Actual Primary Completion Date :||October 21, 2019|
|Actual Study Completion Date :||October 21, 2019|
Active Comparator: Standard rehabilitation
Patients will receive standard post-operative ACL rehabilitation
Other: Standard rehabilitation
Patients will receive standard of care post-operative ACL reconstruction rehabilitation
Experimental: Delfi moderated blood flow restriction
Patients will receive Delfi moderated blood flow post-operative ACL rehabilitation
Patients will receive standard of care post-operative ACL reconstruction rehabilitation plus the Delfi moderated blood flow restriction therapy.
Other Name: moderated blood flow restriction device
- Muscle Strength [ Time Frame: 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
- Range of Motion [ Time Frame: 12 months ]Compare the total Range of motion of the involved leg at 12 months between the Delfi and the control group
- Tegner Activity Survey Score [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 12 months ]Compare the mean VAS scores (0 no pain - 10 worse pain ever) between the Delfi and the control group
- Tight Circumference [ Time Frame: 12 months ]Compare tight circumference of the involved leg between Delfi and the control group
- KT-2000 Anterior Tibial Translation [ Time Frame: 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 [ Time Frame: 12 months ]Compare CK levels at 12 months between delfi and control group
- HGH Level [ Time Frame: 12 months ]Compare mean HGH blood levels between the delfi and the control group
- IGF Level [ Time Frame: 12 months ]Compare the mean IGF blood values between delfi and control group
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 30 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients between 18-30 years of age.
- Diagnosis of isolated anterior cruciate ligament (ACL) tear and pending ACL reconstruction.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02911909
|United States, Missouri|
|Missouri Orthopaedic Institute|
|Columbia, Missouri, United States, 65212|
|Principal Investigator:||James Cook||University of MO-Columbia|
Documents provided by James Cook, University of Missouri-Columbia:
|Responsible Party:||James Cook, William & Kathryn Allen Distinguished Professor in Orthopaedic Surgery, University of Missouri-Columbia|
|Other Study ID Numbers:||
|First Posted:||September 22, 2016 Key Record Dates|
|Results First Posted:||March 11, 2020|
|Last Update Posted:||March 11, 2020|
|Last Verified:||March 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
Anterior Cruciate Ligament Injuries
Wounds and Injuries