NCT06589115

Blood Flow Restriction Therapy Improves Tibial Plateau Fracture Recovery

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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: * Collect functional and patient self-reported outcomes data * Assess leg muscle atrophy * Acquire motion analysis dynamics and knee strength data. Participants will be randomized into either a rehabilitation protocol or that protocol with blood flow restriction and be followed for 1 year.

Detailed description

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.

Conditions

• Tibial Plateau Fractures

Interventions

Type	Name	Description
OTHER	Blood Flow Restriction Cuff	The standardized exercises will be performed while wearing a blood flow restriction cuff.
OTHER	Physical Therapy	Standard physical therapy

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-12-01
• Completion: 2028-12-31
• First posted: 2024-09-19
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States