Anterior Cruciate Ligament TearDelfiNCT02911909
Moderated Blood Flow Restriction After Anterior Cruciate Ligament Reconstruction
A study testing Delfi and Standard rehabilitation in people with Anterior Cruciate Ligament Tear, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Anterior Cruciate Ligament Tear
- What is being tested?
- Delfi and Standard rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 21 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients between 18-30 years of age.
- Diagnosis of isolated anterior cruciate ligament (ACL) tear and pending ACL reconstruction.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Missouri Orthopaedic Institute
Columbia, Missouri, 65212
About this study
Official title: Moderated Blood Flow Restriction After Anterior Cruciate Ligament
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Tear
- Being tested
- Delfi, Standard rehabilitation
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DelfiDevice
Also called moderated blood flow restriction device
Patients will receive standard of care post-operative ACL reconstruction rehabilitation plus the Delfi moderated blood flow restriction therapy.
Standard rehabilitationOther
Patients will receive standard of care post-operative ACL reconstruction rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Standard rehabilitation | Active comparator | Patients will receive standard post-operative ACL rehabilitation Receives: Other: Standard rehabilitation |
| Delfi moderated blood flow restriction | Experimental | Patients will receive Delfi moderated blood flow post-operative ACL rehabilitation Receives: Device: Delfi |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (10)
Range of Motion
Compare the total Range of motion of the involved leg at 12 months between the Delfi and the control group
Measured: 12 months
Tegner Activity Survey Score
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.
Measured: 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Survey Score.
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
Measured: 12 months
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.
Measured: 12 months
Visual Analog Scale (VAS)
Compare the mean VAS scores (0 no pain - 10 worse pain ever) between the Delfi and the control group
Measured: 12 months
Tight Circumference
Compare tight circumference of the involved leg between Delfi and the control group
Measured: 12 months
KT-2000 Anterior Tibial Translation
Compare the mean anterior translation of the tibia between delfi and control groups anterior translation was measured using a KT-2000 device
Measured: 12 months
CK Level
Compare CK levels at 12 months between delfi and control group
Measured: 12 months
HGH Level
Compare mean HGH blood levels between the delfi and the control group
Measured: 12 months
IGF Level
Compare the mean IGF blood values between delfi and control group
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study start1 Oct 2017
- Primary completion21 Oct 2019
- Study completion21 Oct 2019
Why it stopped: Recruitment was unsuccessful
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anterior Cruciate Ligament TearStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Cook, University of Missouri-Columbia
- Investigators
- James Cook, Principal investigator, University of MO-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911909
- Sponsor's protocol ID
- 2004255
- Acronym
- Delfi
- Status last verified
- Mar 2020
- First submitted
- 5 Aug 2016
- Last updated
- 11 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderated Blood Flow Restriction After Anterior Cruciate Ligament
- ClinicalTrials.gov ID
- NCT02911909
- Acronym / sponsor ID
- Delfi / 2004255
- Conditions
- Anterior Cruciate Ligament Tear
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was unsuccessful
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 21 Oct 2019 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Posted 11 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard rehabilitation | Active comparator | Other: Standard rehabilitationPatients will receive standard post-operative ACL rehabilitation |
| Delfi moderated blood flow restriction | Experimental | Device: DelfiPatients will receive Delfi moderated blood flow post-operative ACL rehabilitation |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients between 18-30 years of age.
- Diagnosis of isolated anterior cruciate ligament (ACL) tear and pending ACL reconstruction.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DelfiAlso: moderated blood flow restriction devicePatients will receive standard of care post-operative ACL reconstruction rehabilitation plus the Delfi moderated blood flow restriction therapy. | Device | Delfi moderated blood flow restriction |
| Standard rehabilitationPatients will receive standard of care post-operative ACL reconstruction rehabilitation | Other | Standard rehabilitation |
Primary outcome
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
10 secondary outcomes
Range of Motion
Time frame: 12 months
Tegner Activity Survey Score
Time frame: 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS) Survey Score.
Time frame: 12 months
International Knee Documentation Committee (IKDC) Survey Score
Time frame: 12 months
Visual Analog Scale (VAS)
Time frame: 12 months
Tight Circumference
Time frame: 12 months
KT-2000 Anterior Tibial Translation
Time frame: 12 months
CK Level
Time frame: 12 months
HGH Level
Time frame: 12 months
IGF Level
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Anterior Cruciate Ligament Tear
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Cook principal investigator
University of MO-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delfi and Standard rehabilitation in people with Anterior Cruciate Ligament Tear, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Strength (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.