Effects of Early Weight Bearing on Rehabilitation Outcomes in Patients With Traumatic Ankle and Tibial Plateau Fractures

NCT ID: NCT04028414

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2025-03-31

Brief Summary

The overall objective of this study is to compare outcomes following early versus delayed weight bearing for adult patients operatively treated for an ankle fracture without syndesmotic fixation. Additionally, early weight bearing will be tested in patients with unicondylar plateau fractures that do not involve joint impaction in the context of a pilot study.

Detailed Description

The purpose of this multi-center, randomized controlled trial (RCT) is to compare outcomes following early versus delayed weight bearing among individuals with a traumatic ankle fracture. This study will enroll patients ages 18 or older surgically treated for an ankle fracture or fracture dislocation (without syndesmosis) at participating civilian trauma centers and military treatment facilities. Eligible patients will be identified during hospitalization for definitive treatment and enrolled prior to discharge or at the first post op clinic visit. Patients that consent to participate will complete a baseline assessment at the first post op clinic visit and will be randomized to early versus delayed weight bearing. Both treatment groups will receive standardized exercises that can be done at home or with a therapist. Outcomes will be evaluated at 6 weeks, 3, 6 and 12 months following definitive fracture fixation. All 6 week, 3 and 6 month evaluations will take place in the surgeon's outpatient clinic and involve clinical and radiographic assessments of healing as well as functional outcome surveys. The 12 month evaluation will be conducted by phone except for individuals who were judged not to be healed (clinically or radiographically) at 6 months; these participants will be asked to return for their 12 month evaluation (to assess healing). Simultaneously, a pilot RCT will be conducted in patients 18 or older surgically treated with a unicondylar plateau fracture without joint impaction.

Conditions

Rehabilitation

Study Design

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

Study Groups

Early Weight Bearing

Patients with ankle fractures will be instructed to weight bear as tolerated (WBAT) while in a boot with a heel to toe normal gait and wean from walker or crutches to a cane or no support device. At the 6 week post op visit, patients with ankle fractures will be instructed to wean from the boot and continue full weight bearing as tolerated until full weight bearing is achieved. Patients with plateau fractures will be instructed to begin WBAT until full weight bearing is achieved.

Group Type: EXPERIMENTAL

Early Weight Bearing

Intervention Type: OTHER

Patients will be instruction to weight bear as tolerated while in a boot.

Delayed Weight Bearing

Patients with ankle fractures will be instructed to touch-down (toe touch or foot flat) weight bear (approximately 10% of body weight) while in the boot for. Patients will be instructed to keep foot off of floor or set ball of foot or heal on ground for balance using walker or crutches at all times. After the 6 week post op visit, patients may begin weight bearing as tolerated. Patients with tibial plateau fractures will be instructed to touch down (toe touch or foot flat) weight bear (approximately 10% of body weight) for at least 6 weeks. After the 6 week post op visit, patients may begin weight bearing as tolerated until full weight bearing is achieved.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Early Weight Bearing

Patients will be instruction to weight bear as tolerated while in a boot.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Adults ages 18 or older

2. Surgically treated open or closed fractures of the ankle (OTA Codes 44A,B,C) meeting one of the following criteria:

1. bimalleolar fracture requiring fixation of any two malleoli (i.e. lateral/medial, medial/posterior, lateral/posterior)

2. bimalleolar equivalent SER4 fractures (lateral malleolus fracture requiring fixation and no medial or posterior malleolus fixation)

3. trimalleolar fracture with fixation of at least two malleoli (i.e. lateral/medial, medial/posterior, lateral/posterior)

3. Operative treatment of an isolated lower extremity unicondylar tibial plateau fracture (AO/OTA 41B1, Schatzker Type 1or 4) without joint impaction.

Exclusion Criteria

1. Gustilo Type III injuries or soft tissue injury of either lower extremity that would contra-indicate immediate or delayed WB

2. Syndesmotic injuries/fixation

3. Osteoporosis as defined by treatment with a bisphosphonate and/or other osteoporosis medications, including Prolia and Forteo; or a prior fragility fracture (e.g., spine compression, proximal humerus, distal radius, femoral neck/intertrochanteric fracture)

4. Neuropathy, defined as diagnosis of peripheral neuropathy in medical record, neuropathic foot ulcer, or diminished or absent plantar sensation to light touch.

5. Pathologic fracture related to neoplasm

6. Fractures and dislocations to the ipsilateral or contralateral lower limb that prevent weight bearing as tolerated after fist post-op visit

7. Other contra-indication to immediate or delayed weight bearing (e.g., ipsilateral fracture effecting weight bearing status such as a calcaneus fracture); fractures of the ipsilateral lower extremity that would not affect WB status may be included (e.g., proximal femur, femoral shaft or tibia shaft fractures)

8. Any upper limb injury that would limit upper extremity weight bearing (e.g., surgical neck fracture of proximal humerus)

9. Injuries to other body systems that would affect the ability to comply with either WB protocol (e.g., spinal cord injury; severe TBI; major abdominal or chest injury)

10. Patient has third degree burns on >10% total surface area affecting the study limb

11. Tibial plateau fractures that are required to wear a locking brace or fractures that require fixed immobilization beyond four weeks (e.g., cast)

12. Non-ambulatory pre-injury

13. Pre-injury limitation to ROM of ipsilateral hip, knee or ankle

14. Morbidly obese (BMI ≥40)

15. Documented psychiatric disorder requiring admission in perioperative period

16. Severe problems with maintaining follow-up (e.g., patients who are prisoners or homeless at the time of injury or who are intellectually challenged without adequate family support)

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

Sponsors

Major Extremity Trauma Research Consortium

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Reider, PhD

Role: PRINCIPAL_INVESTIGATOR

Major Extremity Trauma Research Consortium

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of California San Francisco Medical Center

San Francisco, California, United States

Methodist Hospital

Indianapolis, Indiana, United States

University of Maryland R Adams Cowley Shock Trauma Center

Baltimore, Maryland, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Hennepin County Medical Center / Regions Hospita

Minneapolis, Minnesota, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

San Antonio Military Medical Center (SAMMC)

San Antonio, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

University of Washington/Harborview Medical Center

Seattle, Washington, United States

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

W81XWH-18-1-0810

Identifier Type: -

Identifier Source: org_study_id