BFR Therapy After ACL Reconstruction

NCT03794570 | Withdrawn DMC FDA Device

• 1 other identifier: 2018-35
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

ACL Injury; Quadriceps Muscle Atrophy

Outcome Measures

Primary Outcomes (1)

• Change in Quadriceps Cross-Sectional Area

  Change in quadriceps cross-sectional area measured on MRI pre-operatively compared to post-operatively

  Pre-op and 6-weeks post-operative

Secondary Outcomes (3)

• Numeric rating scale pain

  Days 1, 14, and 6 weeks after surgery

• Thigh girth

  Days 1, 14, and 6 weeks after surgery

• Knee joint range of motion

  Days 1, 14, and 6 weeks after surgery

Study Arms (2)

Control

SHAM COMPARATOR

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

Device: Sham blood flow restriction therapy - with Delfi Personalized Tourniquet System

Blood Flow Restriction (BFR) Therapy

EXPERIMENTAL

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

Device: Blood flow restriction therapy - with Delfi Personalized Tourniquet System

Interventions

Blood flow restriction therapy - with Delfi Personalized Tourniquet System DEVICE

Physical therapy performed with Blood flow restriction therapy tourniquet inflated to 80% limb occlusion pressure

Blood Flow Restriction (BFR) Therapy

Sham blood flow restriction therapy - with Delfi Personalized Tourniquet System DEVICE

Physical therapy performed with Blood flow restriction therapy tourniquet inflated to only minimal pressure

Control

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Steadman Philippon Research Institute: lead

Study Sites (1)

The Steadman Clinic

Vail, Colorado, 81657, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients and outcomes assessors will be blinded to treatment group. Physical therapy providers will not be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blinded randomized control trial

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: January 7, 2019
• Study Start: December 18, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: December 4, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)