Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries (AlterG)

Major Extremity Trauma Research Consortium

Status: Completed

Conditions: Pilon Fracture; Distal Tibia Fracture; Tibial Plateau Fracture; Distal Femur Fracture

Treatments: Other: AlterG anti-gravity treadmill

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03562364

W81XWH-16-2-0060 AlterG

Details and patient eligibility

About

The overall objective of this study is to compare outcomes following early advanced weight bearing (EAWB) using the AlterG antigravity treadmill versus standard of care physical therapy for adult patients with lower extremity periarticular injuries.

Enrollment: 81 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages 18-55
• Closed or Open (Gustilo Type I, II or IIIA) fractures: Distal femur (AO/OTA 33B, 33C), tibial plateau (AO/OTA 41B, 41C), or Distal tibia/pilon (AO/OTA 43B, 43C)
• Definitively treated with a plate
• Ambulatory prior to injury
• Able to participate in rehab starting 28 days after definitive fixation
• Meets AlterG requirements (4'8- 6'4; 85-400lbs)

Exclusion criteria

• Medical or psychological disease that would preclude safe functional testing (e.g., severe traumatic brain injury, stroke, heart disease, etc.)
• Prior joint trauma or disease of the operative extremity that resulted in pain, stiffness, or other limitation to mobility
• Injury to the contra-lateral limb, upper extremities or axial skeleton that would influence single limb weight-bearing or use of an assistive device
• Pregnancy
• Unable to speak English
• Severe problems with maintaining follow-up (e.g. patients who are prisoners, homeless at the time of injury, who are intellectually challenged without adequate family support, or have documented psychiatric disorders).
• Unable to provide informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

The standard of care group will remain non-weight bearing for 10-12 weeks following definitive fixation and receive physical therapy in accordance with standard practice at the treating center.

Early Advanced Weight Bearing (EAWB)

Experimental group

Description:

The Early Advanced Weight Bearing (EAWB) group will receive early weight-bearing treatment using the antigravity AlterG treadmill. These sessions will begin 14-28 days following definitive fixation and last for a total of 10 weeks

Treatment:

Other: AlterG anti-gravity treadmill