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Moderated Blood Flow Restriction After Anterior Cruciate Ligament Reconstruction (Delfi)

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ClinicalTrials.gov Identifier: NCT02911909
Recruitment Status : Recruiting
First Posted : September 22, 2016
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
James Cook, University of Missouri-Columbia

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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Tear Device: Delfi Other: Standard rehabilitation Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Moderated Blood Flow Restriction After Anterior Cruciate Ligament
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. 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.

  2. 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)


Secondary Outcome Measures :
  1. Change in HGH level [ Time Frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks ]
    Blood will be drawn at clinic visits

  2. Change in IGF level [ Time Frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks ]
    Blood will be drawn at clinic visits

  3. Change in Tegner Activity Survey score [ Time Frame: 4 months, 6 months, 8 months, 12 months ]
    Knee function will be assessed using the scores of the Tegner activity survey

  4. Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) survey score. [ Time Frame: 4 months, 6 months, 8 months, 12 months ]
    Knee function will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) survey

  5. Change in the International Knee Documentation Committee (IKDC) survey score [ Time Frame: 4 months, 6 months, 8 months, 12 months ]
    Knee function will be assessed using the International Knee Documentation Committee (IKDC) survey

  6. 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

  7. Change in CK level [ Time Frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks ]
    Blood will be drawn at clinic visits



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Harvery Oliver 573-884-4786 oliverha@health.missouri.edu
Contact: Stacee Clawson 573/884-9017 clawsons@health.missouri.edu

Locations
United States, Missouri
Missouri Orthopaedic Institute Recruiting
Columbia, Missouri, United States, 65212
Contact: James Cook, DVM, PhD    573-884-4689    cookjl@health.missouri.edu   
Contact: Stacee Clawson, BSN, RN    573-884-9017    clawsons@health.missouri.edu   
Principal Investigator: James P Stannard, MD         
Sub-Investigator: James Cook, DVM, PhD         
Sub-Investigator: Richard Ma, MD         
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: James Cook University of MO-Columbia

Responsible Party: James Cook, William & Kathryn Allen Distinguished Professor in Orthopaedic Surgery, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02911909     History of Changes
Other Study ID Numbers: 2004255
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
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
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries