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

Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04028414
• Other study ID #: W81XWH-18-1-0810
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: Major Extremity Trauma Research Consortium
• Contact: ELIZABETH WYSOCKI, MS
• Phone: 4109550396
• Email: ewysock2[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Rehabilitation

Intervention

Other:
• Early Weight Bearing
Patients will be instruction to weight bear as tolerated while in a boot.

Locations

Country	Name	City	State
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	University of Alabama at Birmingham	Birmingham	Alabama
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Womack Army Medical Center at Ft. Bragg	Fort Bragg	North Carolina
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	University of Texas Health Science Center - Houston	Houston	Texas
United States	Methodist Hospital	Indianapolis	Indiana
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Wisconsin	Madison	Wisconsin
United States	Hennepin County Medical Center / Regions Hospita	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	San Antonio Military Medical Center (SAMMC)	San Antonio	Texas
United States	University of California San Francisco Medical Center	San Francisco	California
United States	University of Washington/Harborview Medical Center	Seattle	Washington
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Major Extremity Trauma Research Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Study Related Complications Experienced	Re-admissions for a limb related issue and all re-operations on the study limb will be prospectively tracked by the Research Coordinators by routinely scanning hospital admission and orthopaedic surgery logs to identify all admissions and same day surgeries of patients actively enrolled in the study. Complications include loss of reduction and hardware failure, infection, non-union, malunion and fusion.	12 months
Primary	Return to Usual Major Activity and Work Productivity	Participants will be asked what they were doing most of the time during the previous two weeks (working/active duty, laid off/looking for work, going to school, taking care of a home, etc.). If participants are working, the Work Productivity and Activity Impairment (WPAI) questionnaire will be administered.The WPAI measures work time missed and work and activity impairment because of a specified health problem during the past 7 days (http://www.reillyassociates.net/WPAI_SHP.html).	12 months