Trial Outcomes & Findings for Moderated Blood Flow Restriction After Anterior Cruciate Ligament Reconstruction (NCT NCT02911909)

NCT ID: NCT02911909

Last Updated: 2020-03-11

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 7 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2020-03-11

Participant Flow

Participant milestones

Measure	Standard Rehabilitation Patients will receive standard post-operative ACL rehabilitation Standard rehabilitation: Patients will receive standard of care post-operative ACL reconstruction rehabilitation	Delfi Moderated Blood Flow Restriction Patients will receive Delfi moderated blood flow post-operative ACL rehabilitation Delfi: Patients will receive standard of care post-operative ACL reconstruction rehabilitation plus the Delfi moderated blood flow restriction therapy.
Overall Study STARTED	4	3
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Moderated Blood Flow Restriction After Anterior Cruciate Ligament Reconstruction

Baseline characteristics by cohort

Measure	Standard Rehabilitation n=2 Participants Patients will receive standard post-operative ACL rehabilitation Standard rehabilitation: Patients will receive standard of care post-operative ACL reconstruction rehabilitation	Delfi Moderated Blood Flow Restriction Patients will receive Delfi moderated blood flow post-operative ACL rehabilitation Delfi: Patients will receive standard of care post-operative ACL reconstruction rehabilitation plus the Delfi moderated blood flow restriction therapy.	Total n=2 Participants Total of all reporting groups
Age, Continuous	29.5 years STANDARD_DEVIATION 1.5 • n=5 Participants	—	29.5 years STANDARD_DEVIATION 1.5 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: No Subjects in the Deflfi group completed the muscle strength evaluation at 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

Outcome measures

Measure	Standard Rehabilitation n=2 Participants Patients will receive standard post-operative ACL rehabilitation Standard rehabilitation: Patients will receive standard of care post-operative ACL reconstruction rehabilitation	Delfi Moderated Blood Flow Restriction Patients will receive Delfi moderated blood flow post-operative ACL rehabilitation Delfi: Patients will receive standard of care post-operative ACL reconstruction rehabilitation plus the Delfi moderated blood flow restriction therapy.
Muscle Strength	95.5 FT-LBS Standard Deviation 60.7	—

SECONDARY outcome

Timeframe: 12 months

Population: No patient in the Delfi group complete the 12 months evaluation / No data obtained in the Delfi group

Compare the total Range of motion of the involved leg at 12 months between the Delfi and the control group

Outcome measures

Measure	Standard Rehabilitation n=2 Participants Patients will receive standard post-operative ACL rehabilitation Standard rehabilitation: Patients will receive standard of care post-operative ACL reconstruction rehabilitation	Delfi Moderated Blood Flow Restriction Patients will receive Delfi moderated blood flow post-operative ACL rehabilitation Delfi: Patients will receive standard of care post-operative ACL reconstruction rehabilitation plus the Delfi moderated blood flow restriction therapy.
Range of Motion	135 Degrees Standard Deviation 5	—

SECONDARY outcome

Timeframe: 12 months

Population: No patient in the Delfi group complete the 12 months evaluation / No data obtained in the Delfi group

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.

Outcome measures

Measure	Standard Rehabilitation n=2 Participants Patients will receive standard post-operative ACL rehabilitation Standard rehabilitation: Patients will receive standard of care post-operative ACL reconstruction rehabilitation	Delfi Moderated Blood Flow Restriction Patients will receive Delfi moderated blood flow post-operative ACL rehabilitation Delfi: Patients will receive standard of care post-operative ACL reconstruction rehabilitation plus the Delfi moderated blood flow restriction therapy.
Tegner Activity Survey Score	1 score on a scale Standard Deviation 1	—

SECONDARY outcome

Timeframe: 12 months

Population: No patient in the Delfi group complete the 12 months evaluation / No data obtained in the Delfi group

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

Outcome measures

Measure	Standard Rehabilitation n=2 Participants Patients will receive standard post-operative ACL rehabilitation Standard rehabilitation: Patients will receive standard of care post-operative ACL reconstruction rehabilitation	Delfi Moderated Blood Flow Restriction Patients will receive Delfi moderated blood flow post-operative ACL rehabilitation Delfi: Patients will receive standard of care post-operative ACL reconstruction rehabilitation plus the Delfi moderated blood flow restriction therapy.
Patient-Reported Outcomes Measurement Information System (PROMIS) Survey Score.	11.5 score on a scale Standard Deviation 1.5	—

SECONDARY outcome

Timeframe: 12 months

Population: No patient in the Delfi group complete the 12 months evaluation / No data obtained in the Delfi group

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.

Outcome measures

Measure	Standard Rehabilitation n=2 Participants Patients will receive standard post-operative ACL rehabilitation Standard rehabilitation: Patients will receive standard of care post-operative ACL reconstruction rehabilitation	Delfi Moderated Blood Flow Restriction Patients will receive Delfi moderated blood flow post-operative ACL rehabilitation Delfi: Patients will receive standard of care post-operative ACL reconstruction rehabilitation plus the Delfi moderated blood flow restriction therapy.
International Knee Documentation Committee (IKDC) Survey Score	72.415 score on a scale Standard Deviation 27.585	—

SECONDARY outcome

Timeframe: 12 months

Population: No patient in the Delfi group complete the 12 months evaluation / No data obtained in the Delfi group

Compare the mean VAS scores (0 no pain - 10 worse pain ever) between the Delfi and the control group

Outcome measures

Measure	Standard Rehabilitation n=2 Participants Patients will receive standard post-operative ACL rehabilitation Standard rehabilitation: Patients will receive standard of care post-operative ACL reconstruction rehabilitation	Delfi Moderated Blood Flow Restriction Patients will receive Delfi moderated blood flow post-operative ACL rehabilitation Delfi: Patients will receive standard of care post-operative ACL reconstruction rehabilitation plus the Delfi moderated blood flow restriction therapy.
Visual Analog Scale (VAS)	1.5 score on a scale Standard Deviation 1.5	—

SECONDARY outcome

Timeframe: 12 months

Population: No patient in the Delfi group complete the 12 months evaluation / No data obtained in the Delfi group

Compare tight circumference of the involved leg between Delfi and the control group

Outcome measures

Measure	Standard Rehabilitation n=2 Participants Patients will receive standard post-operative ACL rehabilitation Standard rehabilitation: Patients will receive standard of care post-operative ACL reconstruction rehabilitation	Delfi Moderated Blood Flow Restriction Patients will receive Delfi moderated blood flow post-operative ACL rehabilitation Delfi: Patients will receive standard of care post-operative ACL reconstruction rehabilitation plus the Delfi moderated blood flow restriction therapy.
Tight Circumference	49.375 cm Standard Deviation 0.625	—

SECONDARY outcome

Timeframe: 12 months

Population: No patient in the Delfi group complete the 12 months evaluation / No data obtained in the Delfi group

Compare the mean anterior translation of the tibia between delfi and control groups anterior translation was measured using a KT-2000 device

Outcome measures

Measure	Standard Rehabilitation n=2 Participants Patients will receive standard post-operative ACL rehabilitation Standard rehabilitation: Patients will receive standard of care post-operative ACL reconstruction rehabilitation	Delfi Moderated Blood Flow Restriction Patients will receive Delfi moderated blood flow post-operative ACL rehabilitation Delfi: Patients will receive standard of care post-operative ACL reconstruction rehabilitation plus the Delfi moderated blood flow restriction therapy.
KT-2000 Anterior Tibial Translation	9 milimiters Standard Deviation 1	—

SECONDARY outcome

Timeframe: 12 months

Population: Samples were not processed due to study termination

Compare CK levels at 12 months between delfi and control group

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Samples were not processed due to study termination

Compare mean HGH blood levels between the delfi and the control group

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: samples were not processed due to study termination

Compare the mean IGF blood values between delfi and control group

Outcome measures

Outcome data not reported

Adverse Events

Standard Rehabilitation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delfi Moderated Blood Flow Restriction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ennio Rizzo

University of Missouri

Phone: 573-882-7615

Email: eardvb@health.missouri.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place