Atrophy, Muscular, Meniscus Disorder, Meniscus Lesion, Meniscus Tear, Tibial, Meniscus, Torn Tibial
Conditions
Keywords
blood flow restriction, rehabilitation, meniscus repair
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.
Interventions
DEVICEBlood flow restriction (Delfi Personalized Tourniquet System)
The Delfi Personalized Tourniquet System will be utilized to apply the blood flow restriction protocol.
OTHERStandard rehabilitation
Post-operative physical therapy as guided by a standardized protocol for patients undergoing meniscus repair.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Extension Force at Week 1 | Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Peak knee extension force (lbs) evaluated with a hand-held dynamometer |
| Knee Extension Force at Week 2 | Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Peak knee extension force (lbs) evaluated with a hand-held dynamometer |
| Knee Extension Force at Week 3 | Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Peak knee extension force (lbs) evaluated with a hand-held dynamometer |
| Knee Extension Force at Week 4 | Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Peak knee extension force (lbs) evaluated with a hand-held dynamometer |
| Knee Extension Force at Week 5 | Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Peak knee extension force (lbs) evaluated with a hand-held dynamometer |
| Knee Extension Force at Week 6 | Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Peak knee extension force (lbs) evaluated with a hand-held dynamometer |
| Knee Extension Force at Week 7 | Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Peak knee extension force (lbs) evaluated with a hand-held dynamometer |
| Knee Extension Force at Week 8 | Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Peak knee extension force (lbs) evaluated with a hand-held dynamometer |
| Knee Extension Force at Week 9 | Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Peak knee extension force (lbs) evaluated with a hand-held dynamometer |
| Knee Extension Force at Week 10 | Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Peak knee extension force (lbs) evaluated with a hand-held dynamometer |
| Knee Extension Force at Week 11 | Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Peak knee extension force (lbs) evaluated with a hand-held dynamometer |
| Knee Extension Force at Week 12 | Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Peak knee extension force (lbs) evaluated with a hand-held dynamometer |
| Thigh Circumference at Week 1 | Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh |
| Thigh Circumference at Week 2 | Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh |
| Thigh Circumference at Week 3 | Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh |
| Thigh Circumference at Week 4 | Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh |
| Thigh Circumference at Week 5 | Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh |
| Thigh Circumference at Week 6 | Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh |
| Thigh Circumference at Week 7 | Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh |
| Thigh Circumference at Week 8 | Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh |
| Thigh Circumference at Week 9 | Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh |
| Thigh Circumference at Week 10 | Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh |
| Thigh Circumference at Week 11 | Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh |
| Thigh Circumference at Week 12 | Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks) | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Knee Documentation Committee (IKDC) Score at Week 6 | 6 weeks (measured at 6 weeks, 3 months, and 6 months post-operatively) | 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 | 3 months (measured at 6 weeks, 3 months, and 6 months post-operatively) | 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 | 6 months (measured at 6 weeks, 3 months, and 6 months post-operatively) | 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 | 3 months (performed at 3 months and 6 months post-operatively) | 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 centimeters in each direction) / (3\*limb length) \* 100. |
| Y-balance Testing at Week 24 | 6 months (performed at 3 months and 6 months post-operatively) | 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 centimeters in each direction) / (3\*limb length) \* 100. |
| 3-hop Test at Week 12 | 3 months (performed at 3 months and 6 months post-operatively) | 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 | 6 months (performed at 3 months and 6 months post-operatively) | 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 meters. |
| Single Leg Squat Testing at Week 12 | 3 months (performed at 3 months and 6 months post-operatively) | 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 | 6 months (performed at 3 months and 6 months post-operatively) | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSachin Allahabadi, MD
University of California, San Francisco
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 35.4 years STANDARD_DEVIATION 12.6 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 8 |
| other Total, other adverse events | 0 / 7 | 0 / 8 |
| serious Total, serious adverse events | 0 / 7 | 0 / 8 |
Outcome results
None listed