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Study withdrawn prior to enrollment due to lack of available financial resources.
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The goal of this clinical trial is to investigates the effectiveness of physical therapy augmented with blood flow restriction (BFR) therapy relative to standard physical therapy in patients after an open reduction and internal fixation of a closed tibial plateau fracture.
The main aims are:
Participants will be randomized into either a rehabilitation protocol or that protocol with blood flow restriction and be followed for 1 year.
Standardized Surveys: Participants will complete two patient reported functional outcome assessments via questionnaires, the KOOS (Knee Injury and Osteoarthritis Outcome Score) and the PROMIS PF (Patient-Reported Outcomes Measurement Information System Physical Function). The PROMIS PF is a computer adaptive, reliable, and validated instrument used to evaluate patient-reported outcome measures regarding physical function ranging from low to very high, along with mental and social well-being. The KOOS is a knee-specific self-administered questionnaire that assesses five long-term and short-term outcomes of knee injury: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.
Blood Flow Restriction Cuff: Along with standard physical therapy, three of the standardized exercises will be performed while wearing an Owens Delfi blood flow restriction cuff (Delfi Medical, San Antonio, TX). To attain partial vascular occlusion, an easy-fit nylon cuff (11.5 cm x 86 cm, 5mm thick) will be placed as proximal as possible on the patient's thigh of the involved leg. Total limb occlusion pressure will be individualized and set between 60% to 80% of the complete arterial occlusion pressure. Limb occlusive pressure will be calculated with the participants in the position for exercise to ensure accurate calculation of limb occlusive pressure. This individual approach prevents excessive pressure in individuals with lower limb occlusion pressures.
Tape Measure: A non-elastic, flexible plastic tape measure will be used. The thigh circumference will be measured at a point 15 cm proximal to the superior pole of the patella. Calf circumference will be measured at the point of greatest circumference while subjects are supine with the knee extended; subcutaneous tissues will not be compressed.
Motion Analysis: Quantitative motion analysis will be conducted at the Medical College of Wisconsin (MCW) Center for Motion Analysis (CMA) using a motion analysis camera system and wireless surface electromyography (EMG) electrodes to determine temporal-spatial parameters, kinematics, kinetics, and muscle activity during walking, sit-to-stand, forward lunge, and step-up-and-over tasks. A validated standardized gait model will be used.
Leg Strength Assessment: Isometric, concentric and eccentric strength will be assessed using the Biodex System 3 Pro dynamometer. Each subject will undergo bilateral leg strength testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rehabilitation Protocol | Active Comparator | Standard physical therapy will be performed according to the clinic standard with manual lymphatic drainage, cryotherapy, and 20 minutes of physical therapy two times a week for fourteen weeks following the initial post-operative visit. |
|
| Rehabilitation Protocol and Blood Flow Restriction | Experimental | In addition to the standard physical therapy, the blood flow restriction group will also begin standard physical therapy care supplemented with blood flow restriction therapy two times a week for 10 weeks after wound healing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Flow Restriction Cuff | Other | The standardized exercises will be performed while wearing a blood flow restriction cuff. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Collect participant knee injury consequences questionnaire | Participants will complete the KOOS (Knee Injury and Osteoarthritis Outcome Score) questionnaire. | Prior to initiation of therapy, and 3, 6, and 12 months postoperatively |
| Collect participant reported function outcome questionnaire | Participants will complete the PROMIS PF (Patient-Reported Outcomes Measurement Information System Physical Function) questionnaire. | Prior to initiation of therapy, and 3, 6, and 12 months postoperatively |
| Assess leg muscle atrophy | Bilateral thigh and calf circumferential girth measurements will be taken once prior to initiation of therapy and then additionally at 3, 6, and 12 months postoperatively as a surrogate for muscle mass. | Prior to initiation of therapy and 3, 6, and 12 months postoperatively |
| Acquire motion analysis dynamics | Participants will undergo 3D motion analysis with concurrent surface EMG (i.e., the electrical activity of the muscle) during walking, sit-to-stand, forward lunge, and step-up-and-over tasks. | 6 and 12 months postoperatively. |
| Acquire knee strength data. | Bilateral knee strength (i.e., muscle force production) will be assessed for isometric, concentric and eccentric muscle contractions using a Biodex dynamometer. | 6 and 12 months postoperatively. |
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Inclusion Criteria:
Exclusion Criteria:
Patient is unable to provide consent
At time of tibial plateau fracture has evidence of a(n)
History of deep venous thrombosis (DVT)
History of peripheral vascular disease
Body Mass Index > 40
Any history of condition that would affect the patient's ability to bear weight as tolerated post-operatively.
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Nolte, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
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| ID | Term |
|---|---|
| D000092463 | Tibial Plateau Fractures |
| ID | Term |
|---|---|
| D000092443 | Knee Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D013978 | Tibial Fractures |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Physical Therapy | Other | Standard physical therapy |
|
| D007718 |
| Knee Injuries |
| D007869 | Leg Injuries |