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Blood Flow Restriction After Meniscus Repair

Primary Purpose

Meniscus Disorder, Meniscus, Torn Tibial, Meniscus Lesion

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood flow restriction (Delfi Personalized Tourniquet System)
Standard rehabilitation
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniscus Disorder focused on measuring blood flow restriction, rehabilitation, meniscus repair

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants who undergo surgery for arthroscopic meniscus repair

Exclusion Criteria:

  • Participants undergoing surgery for concomitant ligamentous surgeries
  • Patients with Diabetes Mellitus, vascular disease, or infections of the involved extremity

Sites / Locations

  • University of California, San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Blood flow restriction

Standard rehabilitation

Arm Description

The blood flow restriction arm will include the use of the pneumatic tourniquet applied to the operative lower extremity throughout post-operative rehabilitation sessions. The tourniquet pressure will be titrated to 80% of the measured extremity arterial limb occlusion pressure with the participant lying supine.

The standard rehabilitation arm will undergo the same rehabilitation protocol as the experimental arm. A tourniquet will still be applied, but will only be inflated to 20 mmHg, a pressure that will not occlude blood flow.

Outcomes

Primary Outcome Measures

Knee extension torque at Week 1
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Knee extension torque at Week 2
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Knee extension torque at Week 3
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Knee extension torque at Week 4
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Knee extension torque at Week 5
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Knee extension torque at Week 6
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Knee extension torque at Week 7
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Knee extension torque at Week 8
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Knee extension torque at Week 9
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Knee extension torque at Week 10
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Knee extension torque at Week 11
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Knee extension torque at Week 12
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Thigh circumference at Week 1
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh circumference at Week 2
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh circumference at Week 3
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh circumference at Week 4
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh circumference at Week 5
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh circumference at Week 6
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh circumference at Week 7
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh circumference at Week 8
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh circumference at Week 9
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh circumference at Week 10
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh circumference at Week 11
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Thigh circumference at Week 12
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh

Secondary Outcome Measures

International Knee Documentation Committee (IKDC) Score at Week 6
Patient-reported outcome measure (numerical score) from survey. Min: 0 = lowest level of function/highest level of symptoms. Max: 100 = highest level of function/lowest level of symptoms
International Knee Documentation Committee (IKDC) Score at Week 12
Patient-reported outcome measure (numerical score) from survey. Min: 0 = lowest level of function/highest level of symptoms. Max: 100 = highest level of function/lowest level of symptoms
International Knee Documentation Committee (IKDC) Score at Week 24
Patient-reported outcome measure (numerical score) from survey. Min: 0 = lowest level of function/highest level of symptoms. Max: 100 = highest level of function/lowest level of symptoms
Y-balance testing at Week 12
Functional outcome measure (numerical score). The lower quarter Y-balance test evaluates dynamic stability and functional symmetry. The subject stands on a single leg and reaches in three directions (anterior, posteromedial, posterolateral) and a composite score is calculated as a percentage: (sum of reach distances in each direction) / (3*limb length) * 100.
Y-balance testing at Week 24
Functional outcome measure (numerical score). The lower quarter Y-balance test evaluates dynamic stability and functional symmetry. The subject stands on a single leg and reaches in three directions (anterior, posteromedial, posterolateral) and a composite score is calculated as a percentage: (sum of reach distances in each direction) / (3*limb length) * 100.
3-hop test at Week 12
Functional outcome measure (numerical score). The 3-hop test assesses dynamic stability and limb control. The subject hops three times consecutively forward in a same line and at the final landing, pauses in position while a measurement is made from the starting line to the toe at the end of the final hop in centimeters. The test is compared to the contralateral, uninjured limb, and scoring is reported as a percentage of the uninjured limb.
3-hop test at Week 24
Functional outcome measure (numerical score). The 3-hop test assesses dynamic stability and limb control. The subject hops three times consecutively forward in a same line and at the final landing, pauses in position while a measurement is made from the starting line to the toe at the end of the final hop in centimeters. The test is compared to the contralateral, uninjured limb, and scoring is reported as a percentage of the uninjured limb.
Single leg squat testing at Week 12
Functional outcome measure (numerical score). Single leg squat testing evaluates core stability and ability to perform functional movement safely. Subjects will be asked to perform a single leg squat and will be evaluated on 5 criteria, with one point for clinician-rated good performance in each (A) maintenance in balance, depth, speed (B) trunk posture (C) pelvic rotation & tilt (D) Hip adduction or femoral internal rotation (E) knee joint apparent valgus. Min: 0 = poor balance and motor control; Max: 5 = good balance and motor control
Single leg squat testing at Week 24
Functional outcome measure (numerical score). Single leg squat testing evaluates core stability and ability to perform functional movement safely. Subjects will be asked to perform a single leg squat and will be evaluated on 5 criteria, with one point for clinician-rated good performance in each (A) maintenance in balance, depth, speed (B) trunk posture (C) pelvic rotation & tilt (D) Hip adduction or femoral internal rotation (E) knee joint apparent valgus. Min: 0 = poor balance and motor control; Max: 5 = good balance and motor control

Full Information

First Posted
June 15, 2020
Last Updated
January 31, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT04436523
Brief Title
Blood Flow Restriction After Meniscus Repair
Official Title
Outcomes of Blood Flow Restriction Training in Post-operative Rehabilitation After Meniscus Repair Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

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
The purpose of this study is to evaluate post-operative outcomes after meniscus surgery in participants undergoing blood flow restriction training as a rehabilitative adjunct compared to those with standard rehabilitation.
Detailed Description
The investigators will conduct a double-blinded, single-institution, randomized controlled trial to compare patients undergoing arthroscopic meniscus repair with post-operative rehabilitation protocol as (1) a standard-of-care rehabilitative protocol with a non-occlusive blood pressure cuff (inflated to 20-30 mm Hg) applied to the operative extremity versus (2) blood flow restriction training with cuff occlusion applied to the operative extremity. Patients will be enrolled prospectively and pre-operatively at their initial clinic visit after meniscus injury. Rehabilitative exercises would be advanced per the physical therapists' discretion with similar exercises for patients in both groups for direct comparison. These exercises are part of an already-established post-operative protocol that is in place, with the only difference being the addition of the blood flow restriction protocol in the intervention group. All patients would undergo their supervised post-operative rehabilitation at our institution.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniscus Disorder, Meniscus, Torn Tibial, Meniscus Lesion, Meniscus Tear, Tibial, Atrophy, Muscular
Keywords
blood flow restriction, rehabilitation, meniscus repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blood flow restriction
Arm Type
Experimental
Arm Description
The blood flow restriction arm will include the use of the pneumatic tourniquet applied to the operative lower extremity throughout post-operative rehabilitation sessions. The tourniquet pressure will be titrated to 80% of the measured extremity arterial limb occlusion pressure with the participant lying supine.
Arm Title
Standard rehabilitation
Arm Type
Sham Comparator
Arm Description
The standard rehabilitation arm will undergo the same rehabilitation protocol as the experimental arm. A tourniquet will still be applied, but will only be inflated to 20 mmHg, a pressure that will not occlude blood flow.
Intervention Type
Device
Intervention Name(s)
Blood flow restriction (Delfi Personalized Tourniquet System)
Other Intervention Name(s)
Delfi Personalized Tourniquet System
Intervention Description
The Delfi Personalized Tourniquet System will be utilized to apply the blood flow restriction protocol.
Intervention Type
Other
Intervention Name(s)
Standard rehabilitation
Intervention Description
Post-operative physical therapy as guided by a standardized protocol for patients undergoing meniscus repair.
Primary Outcome Measure Information:
Title
Knee extension torque at Week 1
Description
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Time Frame
Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Knee extension torque at Week 2
Description
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Time Frame
Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Knee extension torque at Week 3
Description
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Time Frame
Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Knee extension torque at Week 4
Description
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Time Frame
Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Knee extension torque at Week 5
Description
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Time Frame
Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Knee extension torque at Week 6
Description
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Time Frame
Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Knee extension torque at Week 7
Description
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Time Frame
Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Knee extension torque at Week 8
Description
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Time Frame
Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Knee extension torque at Week 9
Description
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Time Frame
Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Knee extension torque at Week 10
Description
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Time Frame
Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Knee extension torque at Week 11
Description
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Time Frame
Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Knee extension torque at Week 12
Description
Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
Time Frame
Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Thigh circumference at Week 1
Description
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Time Frame
Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Thigh circumference at Week 2
Description
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Time Frame
Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Thigh circumference at Week 3
Description
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Time Frame
Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Thigh circumference at Week 4
Description
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Time Frame
Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Thigh circumference at Week 5
Description
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Time Frame
Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Thigh circumference at Week 6
Description
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Time Frame
Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Thigh circumference at Week 7
Description
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Time Frame
Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Thigh circumference at Week 8
Description
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Time Frame
Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Thigh circumference at Week 9
Description
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Time Frame
Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Thigh circumference at Week 10
Description
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Time Frame
Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Thigh circumference at Week 11
Description
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Time Frame
Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Title
Thigh circumference at Week 12
Description
Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
Time Frame
Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Secondary Outcome Measure Information:
Title
International Knee Documentation Committee (IKDC) Score at Week 6
Description
Patient-reported outcome measure (numerical score) from survey. Min: 0 = lowest level of function/highest level of symptoms. Max: 100 = highest level of function/lowest level of symptoms
Time Frame
6 weeks (measured at 6 weeks, 3 months, and 6 months post-operatively)
Title
International Knee Documentation Committee (IKDC) Score at Week 12
Description
Patient-reported outcome measure (numerical score) from survey. Min: 0 = lowest level of function/highest level of symptoms. Max: 100 = highest level of function/lowest level of symptoms
Time Frame
3 months (measured at 6 weeks, 3 months, and 6 months post-operatively)
Title
International Knee Documentation Committee (IKDC) Score at Week 24
Description
Patient-reported outcome measure (numerical score) from survey. Min: 0 = lowest level of function/highest level of symptoms. Max: 100 = highest level of function/lowest level of symptoms
Time Frame
6 months (measured at 6 weeks, 3 months, and 6 months post-operatively)
Title
Y-balance testing at Week 12
Description
Functional outcome measure (numerical score). The lower quarter Y-balance test evaluates dynamic stability and functional symmetry. The subject stands on a single leg and reaches in three directions (anterior, posteromedial, posterolateral) and a composite score is calculated as a percentage: (sum of reach distances in each direction) / (3*limb length) * 100.
Time Frame
3 months (performed at 3 months and 6 months post-operatively)
Title
Y-balance testing at Week 24
Description
Functional outcome measure (numerical score). The lower quarter Y-balance test evaluates dynamic stability and functional symmetry. The subject stands on a single leg and reaches in three directions (anterior, posteromedial, posterolateral) and a composite score is calculated as a percentage: (sum of reach distances in each direction) / (3*limb length) * 100.
Time Frame
6 months (performed at 3 months and 6 months post-operatively)
Title
3-hop test at Week 12
Description
Functional outcome measure (numerical score). The 3-hop test assesses dynamic stability and limb control. The subject hops three times consecutively forward in a same line and at the final landing, pauses in position while a measurement is made from the starting line to the toe at the end of the final hop in centimeters. The test is compared to the contralateral, uninjured limb, and scoring is reported as a percentage of the uninjured limb.
Time Frame
3 months (performed at 3 months and 6 months post-operatively)
Title
3-hop test at Week 24
Description
Functional outcome measure (numerical score). The 3-hop test assesses dynamic stability and limb control. The subject hops three times consecutively forward in a same line and at the final landing, pauses in position while a measurement is made from the starting line to the toe at the end of the final hop in centimeters. The test is compared to the contralateral, uninjured limb, and scoring is reported as a percentage of the uninjured limb.
Time Frame
6 months (performed at 3 months and 6 months post-operatively)
Title
Single leg squat testing at Week 12
Description
Functional outcome measure (numerical score). Single leg squat testing evaluates core stability and ability to perform functional movement safely. Subjects will be asked to perform a single leg squat and will be evaluated on 5 criteria, with one point for clinician-rated good performance in each (A) maintenance in balance, depth, speed (B) trunk posture (C) pelvic rotation & tilt (D) Hip adduction or femoral internal rotation (E) knee joint apparent valgus. Min: 0 = poor balance and motor control; Max: 5 = good balance and motor control
Time Frame
3 months (performed at 3 months and 6 months post-operatively)
Title
Single leg squat testing at Week 24
Description
Functional outcome measure (numerical score). Single leg squat testing evaluates core stability and ability to perform functional movement safely. Subjects will be asked to perform a single leg squat and will be evaluated on 5 criteria, with one point for clinician-rated good performance in each (A) maintenance in balance, depth, speed (B) trunk posture (C) pelvic rotation & tilt (D) Hip adduction or femoral internal rotation (E) knee joint apparent valgus. Min: 0 = poor balance and motor control; Max: 5 = good balance and motor control
Time Frame
6 months (performed at 3 months and 6 months post-operatively)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants who undergo surgery for arthroscopic meniscus repair Exclusion Criteria: Participants undergoing surgery for concomitant ligamentous surgeries Patients with Diabetes Mellitus, vascular disease, or infections of the involved extremity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sachin Allahabadi, MD
Phone
415-514-6120
Email
sachin.allahabadi@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jocelyn Carpio
Phone
415-514-6120
Email
jocelyn.carpio@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sachin Allahabadi, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sachin Allahabadi, MD
Phone
415-514-6120
Email
sachin.allahabadi@gmail.com
First Name & Middle Initial & Last Name & Degree
Joceyln Carpio
Phone
415-514-6120
Email
jocelyn.carpio@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Drew A Lansdown, MD
First Name & Middle Initial & Last Name & Degree
Brian T Feeley, MD
First Name & Middle Initial & Last Name & Degree
Ivan Arriaga-Martinez, DPT

12. IPD Sharing Statement

Plan to Share IPD
No

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Blood Flow Restriction After Meniscus Repair

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