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BFR Therapy After ACL Reconstruction (BFR)

Primary Purpose

ACL Injury, Quadriceps Muscle Atrophy

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood flow restriction therapy - with Delfi Personalized Tourniquet System
Sham blood flow restriction therapy - with Delfi Personalized Tourniquet System
Sponsored by
Steadman Philippon Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACL Injury

Eligibility Criteria

14 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 14-70
  • Undergoing ACL reconstruction with patellar tendon autograft
  • Full weightbearing after surgery
  • Surgery performed within 14 days of ACL injury
  • No nerve catheter in place

Exclusion Criteria:

  • Meniscal root tears
  • radial meniscal tears
  • multi-ligament knee injury
  • revision ACL reconstruction
  • concomitant osteotomies
  • concomitant cartilage resurfacing procedures
  • fracture preventing full-weightbearing of operated extremity
  • previous history of deep vein thrombosis (DVT)
  • new nerve injury/findings affecting operative extremity
  • active femoral nerve catheter
  • nerve block lasting longer than day of surgery
  • patients unable to tolerate BFR treatment
  • untolerable post-operative pain due to absence of nerve catheter
  • proximal thigh girth greater than 34cm
  • time to surgery greater than 14 days

Sites / Locations

  • The Steadman Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control

Blood Flow Restriction (BFR) Therapy

Arm Description

Patients in this group will have BFR tourniquet applied but inflated to only minimal pressure.

Patients in this group will have BFR tourniquet applied and inflated to 80% limb occlusion pressure

Outcomes

Primary Outcome Measures

Change in Quadriceps Cross-Sectional Area
Change in quadriceps cross-sectional area measured on MRI pre-operatively compared to post-operatively

Secondary Outcome Measures

Numeric rating scale pain
Patient reported pain levels using numeric rating scale (NRS) on a scale of 1-10 where 10 represents maximal pain and 1 represents minimal pain
Thigh girth
Measured thigh girth 15cm above knee joint line
Knee joint range of motion
Measure knee range of motion

Full Information

First Posted
December 20, 2018
Last Updated
December 2, 2019
Sponsor
Steadman Philippon Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03794570
Brief Title
BFR Therapy After ACL Reconstruction
Acronym
BFR
Official Title
Blood Flow Restriction Therapy to Prevent Muscle Atrophy Following Anterior Cruciate Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator separated from institution
Study Start Date
December 18, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Steadman Philippon Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a prospective, double-blinded, randomized control trial examining the effect of blood flow restriction (BFR) therapy on reducing post-operative quadriceps atrophy in patients undergoing anterior cruciate ligament reconstruction (ACLR). Following ACLR, patients will undergo a rehabilitation protocol either w/ BFR therapy or sham BFR therapy.
Detailed Description
Patients will be randomized to either BFR therapy or no BFR therapy. Randomization will be carried out using block randomization with blocks of 6. Those undergoing BFR therapy will have a Delfi Personalized Tourniquet System (PTS) cuff applied to the proximal thigh of their operative leg and inflated to 80% limb occlusive pressure (LOP) calculated by the Delfi PTS device during physical therapy (PT) sessions from day 2 after surgery through day 7 after surgery. Those in the no BFR group will have the Delfi PTS cuff applied to their proximal thigh with inflation of the tourniquet to minimal pressure only. BFR therapy will be administered by health care providers who have undergone training and certification for BFR therapy with the Delfi PTS device. Both groups will undergo the following PT regimen two times daily beginning on the day after the surgical procedure and lasting for 6 weeks post-operatively: Quad sets = x1 min isometric hold, 30 sec off, 3 sets Terminal knee extensions = 3x15, 30 sec rest or short arc quads sitting 1 x 30 + 3 x 15, 30 sec rest Once range of motion (ROM) allows: Bike 10 mins, low to no resistance Each physical therapy visit will last approximately 60 minutes. During that time, there will be a total estimated time of 5-7 minutes during which the tourniquet cuff will be on the thigh, and the tourniquet will be inflated for a similar time period. The tourniquet will inflate for about 1 minute in order to find out the specific pressure for the patient's leg and then will remain inflated until exercises are completed, which should take 4-6 minutes. The cuff will then be deflated and is removed from the leg within about 30 seconds of being deflated. Patients will have MRI performed pre-operatively and at 6 weeks post-operatively with axial cuts to 50% femoral length above joint line. Quadriceps cross-sectional area will be measured by a blinded observer using MRI. Patients will have clinical measurements including thigh girth, Lachman test, knee joint range of motion, and knee joint swelling performed pre-operatively, at post-op day 1, post-op day 14, and 6 weeks post-operatively. All clinical measurements will be performed by a blinded observer. Additionally, patient reported pain level will be obtained at the same timepoints in which clinical measurements are performed using visual analog scale. In order to ensure there are no nerve injuries present in patients prior to undergoing application and inflation of thigh tourniquet, all patients in the study will have single shot adductor and/or sciatic nerve blocks to ensure 24 hour period without nerve block prior to initiation of BFR therapy. Patients included in the study cannot have a nerve block lasting longer than the day of surgery. To ensure no new nerve deficits are present, the patients will undergo a physical examination during morning rounding on post-operative day 1 to assess for new nerve deficits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury, Quadriceps Muscle Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blinded randomized control trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Patients and outcomes assessors will be blinded to treatment group. Physical therapy providers will not be masked.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Patients in this group will have BFR tourniquet applied but inflated to only minimal pressure.
Arm Title
Blood Flow Restriction (BFR) Therapy
Arm Type
Experimental
Arm Description
Patients in this group will have BFR tourniquet applied and inflated to 80% limb occlusion pressure
Intervention Type
Device
Intervention Name(s)
Blood flow restriction therapy - with Delfi Personalized Tourniquet System
Intervention Description
Physical therapy performed with Blood flow restriction therapy tourniquet inflated to 80% limb occlusion pressure
Intervention Type
Device
Intervention Name(s)
Sham blood flow restriction therapy - with Delfi Personalized Tourniquet System
Intervention Description
Physical therapy performed with Blood flow restriction therapy tourniquet inflated to only minimal pressure
Primary Outcome Measure Information:
Title
Change in Quadriceps Cross-Sectional Area
Description
Change in quadriceps cross-sectional area measured on MRI pre-operatively compared to post-operatively
Time Frame
Pre-op and 6-weeks post-operative
Secondary Outcome Measure Information:
Title
Numeric rating scale pain
Description
Patient reported pain levels using numeric rating scale (NRS) on a scale of 1-10 where 10 represents maximal pain and 1 represents minimal pain
Time Frame
Days 1, 14, and 6 weeks after surgery
Title
Thigh girth
Description
Measured thigh girth 15cm above knee joint line
Time Frame
Days 1, 14, and 6 weeks after surgery
Title
Knee joint range of motion
Description
Measure knee range of motion
Time Frame
Days 1, 14, and 6 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 14-70 Undergoing ACL reconstruction with patellar tendon autograft Full weightbearing after surgery Surgery performed within 14 days of ACL injury No nerve catheter in place Exclusion Criteria: Meniscal root tears radial meniscal tears multi-ligament knee injury revision ACL reconstruction concomitant osteotomies concomitant cartilage resurfacing procedures fracture preventing full-weightbearing of operated extremity previous history of deep vein thrombosis (DVT) new nerve injury/findings affecting operative extremity active femoral nerve catheter nerve block lasting longer than day of surgery patients unable to tolerate BFR treatment untolerable post-operative pain due to absence of nerve catheter proximal thigh girth greater than 34cm time to surgery greater than 14 days
Facility Information:
Facility Name
The Steadman Clinic
City
Vail
State/Province
Colorado
ZIP/Postal Code
81657
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No sharing

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BFR Therapy After ACL Reconstruction

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