Blood Flow Restriction Therapy Improves Tibial Plateau Fracture Recovery

NCT ID: NCT06589115

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2028-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rehabilitation Protocol

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.

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: OTHER

Standard physical therapy

Rehabilitation Protocol and Blood Flow Restriction

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.

Group Type: EXPERIMENTAL

Blood Flow Restriction Cuff

Intervention Type: OTHER

The standardized exercises will be performed while wearing a blood flow restriction cuff.

Physical Therapy

Intervention Type: OTHER

Standard physical therapy

Interventions

Blood Flow Restriction Cuff

The standardized exercises will be performed while wearing a blood flow restriction cuff.

Intervention Type: OTHER

Physical Therapy

Standard physical therapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Equal to or greater than 18 years of age

2. ORIF (open reduction and internal fixation) of a closed unicondylar tibial plateau fracture

3. Planning to attend physical therapy at one of the eligible Froedtert locations with BFR therapy capabilities

Exclusion Criteria

1. Patient is unable to provide consent

2. At time of tibial plateau fracture has evidence of a(n)

1. Open fracture(s)

2. Fracture(s) with associated vascular injury,

3. Fracture(s) with extensive soft tissue injury preventing the ability to apply a tourniquet

4. Ipsilateral or contralateral lower extremity fracture(s)

5. Pelvic or spinal trauma

3. History of deep venous thrombosis (DVT)

4. History of peripheral vascular disease

5. Body Mass Index > 40

6. Any history of condition that would affect the patient's ability to bear weight as tolerated post-operatively.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Nolte

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Nolte, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

PRO00047532

Identifier Type: -

Identifier Source: org_study_id