NCT02911909

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
1 year until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2019

Completed
5 months until next milestone

Results Posted

Study results publicly available

March 11, 2020

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

2.1 years

First QC Date

August 5, 2016

Results QC Date

November 4, 2019

Last Update Submit

March 5, 2020

Conditions

Anterior Cruciate Ligament Tear

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Secondary Outcomes (10)

  • Range of Motion

    12 months

  • Tegner Activity Survey Score

    12 months

  • Patient-Reported Outcomes Measurement Information System (PROMIS) Survey Score.

    12 months

  • International Knee Documentation Committee (IKDC) Survey Score

    12 months

  • Visual Analog Scale (VAS)

    12 months

  • +5 more secondary outcomes

Study Arms (2)

Standard rehabilitation

ACTIVE COMPARATOR

Patients will receive standard post-operative ACL rehabilitation

Other: Standard rehabilitation

Delfi moderated blood flow restriction

EXPERIMENTAL

Patients will receive Delfi moderated blood flow post-operative ACL rehabilitation

Device: Delfi

Interventions

DelfiDEVICE

Patients will receive standard of care post-operative ACL reconstruction rehabilitation plus the Delfi moderated blood flow restriction therapy.

Also known as: moderated blood flow restriction device
Delfi moderated blood flow restriction
Standard rehabilitationOTHER

Patients will receive standard of care post-operative ACL reconstruction rehabilitation

Standard rehabilitation

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients between 18-30 years of age.
  • Diagnosis of isolated anterior cruciate ligament (ACL) tear and pending ACL reconstruction.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Missouri Orthopaedic Institute

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Limitations and Caveats

Finding patients that meet all the inclusion criteria was cumbersome. Some patients after enrollment had intra-operative findings that would later make them not eligible to keep participating in the study (required procedures beyond ACL recon)

Results Point of Contact

Title
Ennio Rizzo
Organization
University of Missouri
eardvb@health.missouri.edu
573-882-7615

Study Officials

  • James Cook

    University of MO-Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
William & Kathryn Allen Distinguished Professor in Orthopaedic Surgery

Study Record Dates

First Submitted

August 5, 2016

First Posted

September 22, 2016

Study Start

October 1, 2017

Primary Completion

October 21, 2019

Study Completion

October 21, 2019

Last Updated

March 11, 2020

Results First Posted

March 11, 2020

Record last verified: 2020-03

Locations

US(1)