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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
70
The Delfi Personalized Tourniquet System will be utilized to apply the blood flow restriction protocol.
Post-operative physical therapy as guided by a standardized protocol for patients undergoing meniscus repair.
University of California, San Francisco
San Francisco, California, United States
RECRUITINGKnee extension torque at Week 1
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)
Knee extension torque at Week 2
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)
Knee extension torque at Week 3
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)
Knee extension torque at Week 4
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)
Knee extension torque at Week 5
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)
Knee extension torque at Week 6
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)
Knee extension torque at Week 7
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Knee extension torque at Week 8
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)
Knee extension torque at Week 9
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)
Knee extension torque at Week 10
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)
Knee extension torque at Week 11
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)
Knee extension torque at Week 12
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)
Thigh circumference at Week 1
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)
Thigh circumference at Week 2
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)
Thigh circumference at Week 3
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)
Thigh circumference at Week 4
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)
Thigh circumference at Week 5
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)
Thigh circumference at Week 6
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)
Thigh circumference at Week 7
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)
Thigh circumference at Week 8
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)
Thigh circumference at Week 9
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)
Thigh circumference at Week 10
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)
Thigh circumference at Week 11
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)
Thigh circumference at Week 12
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)
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
Time frame: 6 weeks (measured at 6 weeks, 3 months, and 6 months post-operatively)
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
Time frame: 3 months (measured at 6 weeks, 3 months, and 6 months post-operatively)
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
Time frame: 6 months (measured at 6 weeks, 3 months, and 6 months post-operatively)
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.
Time frame: 3 months (performed at 3 months and 6 months post-operatively)
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.
Time frame: 6 months (performed at 3 months and 6 months post-operatively)
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.
Time frame: 3 months (performed at 3 months and 6 months post-operatively)
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.
Time frame: 6 months (performed at 3 months and 6 months post-operatively)
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
Time frame: 3 months (performed at 3 months and 6 months post-operatively)
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
Time frame: 6 months (performed at 3 months and 6 months post-operatively)