Blood Flow Restriction Therapy Improves Tibial Plateau Fracture Recovery

NCT06589115 | Withdrawn

• 1 other identifier: PRO00047532
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Tibial Plateau Fractures

Outcome Measures

Primary Outcomes (5)

• 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.

Study Arms (2)

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.

Other: Physical Therapy

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.

Other: Blood Flow Restriction Cuff; Other: Physical Therapy

Interventions

Blood Flow Restriction Cuff OTHER

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

Rehabilitation Protocol and Blood Flow Restriction

Physical Therapy OTHER

Standard physical therapy

Rehabilitation Protocol; Rehabilitation Protocol and Blood Flow Restriction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Equal to or greater than 18 years of age
• ORIF (open reduction and internal fixation) of a closed unicondylar tibial plateau fracture
• Planning to attend physical therapy at one of the eligible Froedtert locations with BFR therapy capabilities

You may not qualify if:

• Patient is unable to provide consent
• At time of tibial plateau fracture has evidence of a(n)
• Open fracture(s)
• Fracture(s) with associated vascular injury,
• Fracture(s) with extensive soft tissue injury preventing the ability to apply a tourniquet
• Ipsilateral or contralateral lower extremity fracture(s)
• Pelvic or spinal trauma
• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Tibial Plateau Fractures

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Knee Fractures; Fractures, Bone; Wounds and Injuries; Tibial Fractures; Knee Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Elizabeth Nolte, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: September 19, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)