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, 2018
|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)|
|Estimated Enrollment :||50 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|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 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
- 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 in HGH level [ Time Frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks ]Blood will be drawn at clinic visits
- Change in IGF level [ Time Frame: Baseline, 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, 8 months, 12 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, 8 months, 12 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, 8 months, 12 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
- Change in CK level [ Time Frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 24 weeks ]Blood will be drawn at clinic visits
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
|Contact: Harvery Oliveremail@example.com|
|Contact: Stacee Clawsonfirstname.lastname@example.org|
|United States, Missouri|
|Missouri Orthopaedic Institute||Recruiting|
|Columbia, Missouri, United States, 65212|
|Contact: James Cook, DVM, PhD 573-884-4689 email@example.com|
|Contact: Stacee Clawson, BSN, RN 573-884-9017 firstname.lastname@example.org|
|Principal Investigator: James P Stannard, MD|
|Sub-Investigator: James Cook, DVM, PhD|
|Sub-Investigator: Richard Ma, MD|
|Principal Investigator:||James Cook||University of MO-Columbia|