RehabilitationNCT04028414
Effects of Early Weight Bearing on Rehabilitation Outcomes in Patients With Traumatic Ankle and Tibial Plateau Fractures
A study testing Early Weight Bearing in people with Rehabilitation, run by Major Extremity Trauma Research Consortium at 17 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rehabilitation
- What is being tested?
- Early Weight Bearing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 435 participants
- Where
- 17 sitesUnited States
- Study dates
- 1 Jan 2020to 23 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ages 18 or older
- Surgically treated open or closed fractures of the ankle (OTA Codes 44A,B,C) meeting one of the following criteria:
- bimalleolar fracture requiring fixation of any two malleoli (i.e. lateral/medial, medial/posterior, lateral/posterior)
- bimalleolar equivalent SER4 fractures (lateral malleolus fracture requiring fixation and no medial or posterior malleolus fixation)
- trimalleolar fracture with fixation of at least two malleoli (i.e. lateral/medial, medial/posterior, lateral/posterior)
- Operative treatment of an isolated lower extremity unicondylar tibial plateau fracture (AO/OTA 41B1, Schatzker Type 1or 4) without joint impaction.
Who cannot join
- Gustilo Type III injuries or soft tissue injury of either lower extremity that would contra-indicate immediate or delayed WB
- Syndesmotic injuries/fixation
- 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)
- Neuropathy, defined as diagnosis of peripheral neuropathy in medical record, neuropathic foot ulcer, or diminished or absent plantar sensation to light touch.
- Pathologic fracture related to neoplasm
- Fractures and dislocations to the ipsilateral or contralateral lower limb that prevent weight bearing as tolerated after fist post-op visit
Show all 16Show fewer
- 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)
- Any upper limb injury that would limit upper extremity weight bearing (e.g., surgical neck fracture of proximal humerus)
- 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)
- Patient has third degree burns on >10% total surface area affecting the study limb
- Tibial plateau fractures that are required to wear a locking brace or fractures that require fixed immobilization beyond four weeks (e.g., cast)
- Non-ambulatory pre-injury
- Pre-injury limitation to ROM of ipsilateral hip, knee or ankle
- Morbidly obese (BMI ≥40)
- Documented psychiatric disorder requiring admission in perioperative period
- 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)
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Carolinas Medical Center
Charlotte, North Carolina, 28204
University of Virginia
Charlottesville, Virginia, 22908
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Methodist Hospital
Indianapolis, Indiana, 46202
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Wisconsin
Madison, Wisconsin, 53705
Hennepin County Medical Center / Regions Hospita
Minneapolis, Minnesota, 55415
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of Oklahoma
Oklahoma City, Oklahoma, 73104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
San Antonio Military Medical Center (SAMMC)
San Antonio, Texas, 78234
University of California San Francisco Medical Center
San Francisco, California, 94143
University of Washington/Harborview Medical Center
Seattle, Washington, 98104
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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
- Being tested
- Early Weight Bearing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Weight BearingOther
Patients will be instruction to weight bear as tolerated while in a boot.
| Study group | Role | What they receive |
|---|---|---|
| Early Weight Bearing | Experimental | 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. Receives: Other: Early Weight Bearing |
| Delayed Weight Bearing | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start1 Jan 2020
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Reider, PhD, Principal investigator, Major Extremity Trauma Research Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028414
- Sponsor's protocol ID
- W81XWH-18-1-0810
- Status last verified
- Apr 2026
- First submitted
- 17 Jul 2019
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing beyond manuscripts and scientific presentations will be processed through the METRC website in the short term. Currently, a standard form will be available for researchers outside METRC to request access to final data generated from METRC studies. These requests will be transmitted to the METRC Coordinating Center for initial review to make sure the relevant materials are provided in support of the request. METRC is committed to making data as widely available as possible while safeguarding the privacy of study participants and protecting the intellectual property of the Consortium. Data will only be made available after it is completely stripped of identifiable information such as dates, geographic locators, and any other event information which is sufficiently rare as to make it possible to deduce the identity of an individual participant. When necessary for complete de-identification, data may be grouped.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Weight Bearing on Rehabilitation Outcomes in Patients With Traumatic Ankle and Tibial Plateau Fractures
- ClinicalTrials.gov ID
- NCT04028414
- Acronym / sponsor ID
- W81XWH-18-1-0810
- Conditions
- Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Weight Bearing | Experimental | Other: Early Weight BearingPatients 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. |
| Delayed Weight Bearing | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults ages 18 or older
- Surgically treated open or closed fractures of the ankle (OTA Codes 44A,B,C) meeting one of the following criteria:
- Operative treatment of an isolated lower extremity unicondylar tibial plateau fracture (AO/OTA 41B1, Schatzker Type 1or 4) without joint impaction.
Key exclusion criteria (16 listed)
- Gustilo Type III injuries or soft tissue injury of either lower extremity that would contra-indicate immediate or delayed WB
- Syndesmotic injuries/fixation
- 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)
- Neuropathy, defined as diagnosis of peripheral neuropathy in medical record, neuropathic foot ulcer, or diminished or absent plantar sensation to light touch.
- Pathologic fracture related to neoplasm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Weight BearingPatients will be instruction to weight bear as tolerated while in a boot. | Other | Early Weight Bearing |
Primary outcome
Number of Study Related Complications Experienced
Time frame: 12 months
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.
Return to Usual Major Activity and Work Productivity
Time frame: 12 months
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Yes. Data sharing beyond manuscripts and scientific presentations will be processed through the METRC website in the short term. Currently, a standard form will be available for researchers outside METRC to request access to final data generated from METRC studies. These requests will be transmitted to the METRC Coordinating Center for initial review to make sure the relevant materials are provided in support of the request. METRC is committed to making data as widely available as possible while safeguarding the privacy of study participants and protecting the intellectual property of the Consortium. Data will only be made available after it is completely stripped of identifiable information such as dates, geographic locators, and any other event information which is sufficiently rare as to make it possible to deduce the identity of an individual participant. When necessary for complete de-identification, data may be grouped.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Reider, PhD principal investigator
Major Extremity Trauma Research Consortium
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Weight Bearing in people with Rehabilitation, run by Major Extremity Trauma Research Consortium at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Study Related Complications Experienced (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.