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Trial record 3 of 29 for:    DELFI

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
Sponsor:
Information provided by (Responsible Party):
James Cook, University of Missouri-Columbia

Tracking Information
First Submitted Date  ICMJE August 5, 2016
First Posted Date  ICMJE September 22, 2016
Results First Submitted Date  ICMJE November 4, 2019
Results First Posted Date  ICMJE March 11, 2020
Last Update Posted Date March 11, 2020
Actual Study Start Date  ICMJE October 1, 2017
Actual Primary Completion Date October 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2016)
  • Change in muscle strength [ Time Frame: 2 weeks, 1 month, 4 months, 6 months, 8 months, 12 months ]
    KT 2000 arthrometer will be used to measure knee strength in millimeters in relation to pounds of force exerted.
  • Change in Lachman test score for knee range of motion [ Time Frame: 2 weeks, 1 month, 4 months, 6 months, 8 months, 12 months ]
    Lachman test will measure range of motion in millimeters (mm)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2016)
  • Change in HGH level [ Time Frame: 2 weeks, 6 weeks, 12 weeks, 24 weeks ]
    Blood will be drawn at clinic visits
  • Change in IGF level [ Time Frame: 2 weeks, 6 weeks, 12 weeks, 24 weeks ]
    Blood will be drawn at clinic visits
  • Change in Tegner Activity Survey score [ Time Frame: 4 months, 6 months, 12 months, 24 months ]
    Knee function will be assessed using the scores of the Tegner activity survey
  • Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) survey score. [ Time Frame: 4 months, 6 months, 12 months, 24 months ]
    Knee function will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) survey
  • Change in the International Knee Documentation Committee (IKDC) survey score [ Time Frame: 4 months, 6 months, 12 months, 24 months ]
    Knee function will be assessed using the International Knee Documentation Committee (IKDC) survey
  • Change in the Visual Analog Scale [ Time Frame: 4 months, 6 months, 12 months, 24 months ]
    Knee function will be assessed using the Visual Analog Scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Moderated Blood Flow Restriction After Anterior Cruciate Ligament Reconstruction
Official Title  ICMJE Moderated Blood Flow Restriction After Anterior Cruciate Ligament
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anterior Cruciate Ligament Tear
Intervention  ICMJE
  • Device: Delfi
    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
  • Other: Standard rehabilitation
    Patients will receive standard of care post-operative ACL reconstruction rehabilitation
Study Arms  ICMJE
  • Active Comparator: Standard rehabilitation
    Patients will receive standard post-operative ACL rehabilitation
    Intervention: Other: Standard rehabilitation
  • Experimental: Delfi moderated blood flow restriction
    Patients will receive Delfi moderated blood flow post-operative ACL rehabilitation
    Intervention: Device: Delfi
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 24, 2019)
7
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2016)
50
Actual Study Completion Date  ICMJE October 21, 2019
Actual Primary Completion Date October 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02911909
Other Study ID Numbers  ICMJE 2004255
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party James Cook, University of Missouri-Columbia
Original Responsible Party University of Missouri-Columbia
Current Study Sponsor  ICMJE University of Missouri-Columbia
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Cook University of MO-Columbia
PRS Account University of Missouri-Columbia
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP