Early MobilizationNCT06389240
Early Weight Bearing in Unicondylar Tibial Plateau Fractures
An observational study of Early Mobilization, run by University of Utah at 1 site in United States.
Trial summary
The investigators aim of the study is to assess the effects of early mobilization after surgically treated unicondylar tibia plateau fractures (6 weeks without weight bearing) on gait, patient satisfaction, return to work/sports and complication rate. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Early Mobilization
- What is being tested?
- 6 weeks post-operatively early weight bearing
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2022to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- Adult, Older adult
Study population: Adult patients,18 - 65 years of age with a unilateral tibial plateau fracture.
Who may be able to join
- Adult patients, at least 18 years of age, max 65 years of age
- Unilateral tibial plateau fracture AO:41b/c
- Written consent to participate (consent can be revoked at any time without giving reasons)
- Surgery during the study period
- Follow-up on-site (Salt Lake City, Utah, United States)
Who cannot join
- Multiple injured or polytraumatized patients
- Other injuries or illnesses that impair the patient's mobility or gait
- Cognitive limitations such as dementia, delirium or similar disease
- Refusal to participate
- Severe underlying disease with significant limitations in the ability to regenerate e.g.
- malignancies
Show all 9Show fewer
- Pathologic or osteoporotic fractures
- Unable to attend clinic in person for follow-ups
- pregnant women and fetus
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Utah Orthopedics
Salt Lake City, Utah, 84108
About this study
Official title: Early Weight Bearing in Unicondylar Tibial Plateau Fractures: How Does it Affect Gait Pattern, Mobility and Overall Outcome: A Randomized Controlled Trial
The investigators aim of the study is to assess the effects of early mobilization after surgically treated unicondylar tibia plateau fractures (6 weeks without weight bearing) on gait, patient satisfaction, return to work/sports and complication rate. The data will be compared to a 10-12 week non-weight bearing group (standard of care).
It is assumed that earlier mobilization does not lead to an increase in the complications - in particular osteosynthesis failure and infections -, but leads to improved patient satisfaction, reduced return to work/sports times, and has a positive impact on the overall outcome
Read the detailed description
Tibial plateau fractures are common sports injuries caused by accidents such as skiing and mountain biking. Thus, young adults with high functional and athletic demands are often affected. The best possible restoration of the original joint function and resilience is therefore particularly important for this group of patients. In addition, prolonged immobilization in this patient group poses a high risk of loss of earnings and a significant impairment in athletic performance.
These injuries usually require surgical treatment which is followed by 10-12 weeks without weight bearing. In recent years, there has been a shift towards earlier mobilization with many injuries. In addition, numerous studies showed the negative effects of prolonged immobility. Nevertheless, these negative effects must always be weighed against the possibility of osteosynthesis failure.
- Conditions
- Early Mobilization
- Being tested
- 6 weeks post-operatively early weight bearing, 10 weeks post-operatively weight bearing (standard of care)
- Keywords
- unicondylar tibia plateau fractures, early mobilization, Gait analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 weeks post-operatively early weight bearingOther
Early mobilization 6 weeks post-operatively. Gait analyses is carried out on when full mobilization is allowed. Gait analysis is performed while using force-measuring insoles (loadsol, Novel).
10 weeks post-operatively weight bearing (standard of care)Other
Standard of care mobilization at 10 weeks post-operatively. Gait analyses is carried out on when full mobilization is allowed. Gait analysis is performed while using force-measuring insoles (loadsol, Novel).
| Study group | Role | What they receive |
|---|---|---|
| 6 weeks post-operatively early weight bearing | Full weight bearing will be allowed 6 weeks post-operatively. Gait analyses is carried out on when full weight-bearing is allowed. Receives: Other: 6 weeks post-operatively early weight bearing | |
| 10 weeks post-operatively weight bearing (standard of care) | Full weight bearing will be allowed 10 weeks post-operatively. Gait analyses is carried out on when full weight-bearing is allowed. Receives: Other: 10 weeks post-operatively weight bearing (standard of care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average peak load (Newtons (N))
Gait analysis is performed while using force-measuring insoles. Patients are asked to complete an parcours with the force-measuring insoles (stand up from a chair with armrests, walk 10 meters, turn, walk back and sit down again. Afterwards (if possible), 5 steps with a handrail should be climbed up and down.
Measured: 6 weeks for early mobilization group
Average peak load (Newtons (N))
Gait analysis is performed while using force-measuring insoles. Patients are asked to complete an parcours with the force-measuring insoles (stand up from a chair with armrests, walk 10 meters, turn, walk back and sit down again. Afterwards (if possible), 5 steps with a handrail should be climbed up and down.
Measured: 10 weeks for standard of care (SOC) group
Average peak load (Newtons (N))
Gait analysis is performed while using force-measuring insoles. Patients are asked to complete an parcours with the force-measuring insoles (stand up from a chair with armrests, walk 10 meters, turn, walk back and sit down again. Afterwards (if possible), 5 steps with a handrail should be climbed up and down.
Measured: 1 week after full weight bearing is allowed for both 6 week early mobilization and SOC groups.
Average peak load (Newtons (N))
Gait analysis is performed while using force-measuring insoles. Patients are asked to complete an parcours with the force-measuring insoles (stand up from a chair with armrests, walk 10 meters, turn, walk back and sit down again. Afterwards (if possible), 5 steps with a handrail should be climbed up and down.
Measured: 2 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.
Average peak load (Newtons (N))
Gait analysis is performed while using force-measuring insoles. Patients are asked to complete an parcours with the force-measuring insoles (stand up from a chair with armrests, walk 10 meters, turn, walk back and sit down again. Afterwards (if possible), 5 steps with a handrail should be climbed up and down.
Measured: 6 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.
Average peak load (Newtons (N))
Gait analysis is performed while using force-measuring insoles. Patients are asked to complete an parcours with the force-measuring insoles (stand up from a chair with armrests, walk 10 meters, turn, walk back and sit down again. Afterwards (if possible), 5 steps with a handrail should be climbed up and down.
Measured: 12 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.
Average peak load (Newtons (N))
Gait analysis is performed while using force-measuring insoles. Patients are asked to complete an parcours with the force-measuring insoles (stand up from a chair with armrests, walk 10 meters, turn, walk back and sit down again. Afterwards (if possible), 5 steps with a handrail should be climbed up and down.
Measured: 6 months after full weight bearing is allowed for both 6 week early mobilization and SOC groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start21 Dec 2022
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early MobilizationStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Haller, University of Utah
- Investigators
- Justin Haller, M.D., Principal investigator, University of Utah Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389240
- Sponsor's protocol ID
- 160848
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Weight Bearing in Unicondylar Tibial Plateau Fractures: How Does it Affect Gait Pattern, Mobility and Overall Outcome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06389240
- Acronym / sponsor ID
- 160848
- Conditions
- Early Mobilization
- Keywords
- unicondylar tibia plateau fractures, early mobilization, Gait analysis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Apr 2024 (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 investigators aim of the study is to assess the effects of early mobilization after surgically treated unicondylar tibia plateau fractures (6 weeks without weight bearing) on gait, patient satisfaction, return to work/sports and complication rate. The data will be compared to a 10-12 week non-weight bearing group (standard of care).
It is assumed that earlier mobilization does not lead to an increase in the complications - in particular osteosynthesis failure and infections -, but leads to improved patient satisfaction, reduced return to work/sports times, and has a positive impact on the overall outcome
Detailed description
Tibial plateau fractures are common sports injuries caused by accidents such as skiing and mountain biking. Thus, young adults with high functional and athletic demands are often affected. The best possible restoration of the original joint function and resilience is therefore particularly important for this group of patients. In addition, prolonged immobilization in this patient group poses a high risk of loss of earnings and a significant impairment in athletic performance.
These injuries usually require surgical treatment which is followed by 10-12 weeks without weight bearing. In recent years, there has been a shift towards earlier mobilization with many injuries. In addition, numerous studies showed the negative effects of prolonged immobility. Nevertheless, these negative effects must always be weighed against the possibility of osteosynthesis failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6 weeks post-operatively early weight bearing | – | Other: 6 weeks post-operatively early weight bearingFull weight bearing will be allowed 6 weeks post-operatively. Gait analyses is carried out on when full weight-bearing is allowed. |
| 10 weeks post-operatively weight bearing (standard of care) | – | Other: 10 weeks post-operatively weight bearing (standard of care)Full weight bearing will be allowed 10 weeks post-operatively. Gait analyses is carried out on when full weight-bearing is allowed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients,18 - 65 years of age with a unilateral tibial plateau fracture.
Key inclusion criteria (5 listed)
- Adult patients, at least 18 years of age, max 65 years of age
- Unilateral tibial plateau fracture AO:41b/c
- Written consent to participate (consent can be revoked at any time without giving reasons)
- Surgery during the study period
- Follow-up on-site (Salt Lake City, Utah, United States)
Key exclusion criteria (9 listed)
- Multiple injured or polytraumatized patients
- Other injuries or illnesses that impair the patient's mobility or gait
- Cognitive limitations such as dementia, delirium or similar disease
- Refusal to participate
- Severe underlying disease with significant limitations in the ability to regenerate e.g.
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 |
|---|---|---|
| 6 weeks post-operatively early weight bearingEarly mobilization 6 weeks post-operatively. Gait analyses is carried out on when full mobilization is allowed. Gait analysis is performed while using force-measuring insoles (loadsol, Novel). | Other | 6 weeks post-operatively early weight bearing |
| 10 weeks post-operatively weight bearing (standard of care)Standard of care mobilization at 10 weeks post-operatively. Gait analyses is carried out on when full mobilization is allowed. Gait analysis is performed while using force-measuring insoles (loadsol, Novel). | Other | 10 weeks post-operatively weight bearing (standard of care) |
Primary outcome
Average peak load (Newtons (N))
Time frame: 6 weeks for early mobilization group
Gait analysis is performed while using force-measuring insoles. Patients are asked to complete an parcours with the force-measuring insoles (stand up from a chair with armrests, walk 10 meters, turn, walk back and sit down again. Afterwards (if possible), 5 steps with a handrail should be climbed up and down.
Average peak load (Newtons (N))
Time frame: 10 weeks for standard of care (SOC) group
Gait analysis is performed while using force-measuring insoles. Patients are asked to complete an parcours with the force-measuring insoles (stand up from a chair with armrests, walk 10 meters, turn, walk back and sit down again. Afterwards (if possible), 5 steps with a handrail should be climbed up and down.
Average peak load (Newtons (N))
Time frame: 1 week after full weight bearing is allowed for both 6 week early mobilization and SOC groups.
Gait analysis is performed while using force-measuring insoles. Patients are asked to complete an parcours with the force-measuring insoles (stand up from a chair with armrests, walk 10 meters, turn, walk back and sit down again. Afterwards (if possible), 5 steps with a handrail should be climbed up and down.
Average peak load (Newtons (N))
Time frame: 2 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.
Gait analysis is performed while using force-measuring insoles. Patients are asked to complete an parcours with the force-measuring insoles (stand up from a chair with armrests, walk 10 meters, turn, walk back and sit down again. Afterwards (if possible), 5 steps with a handrail should be climbed up and down.
Average peak load (Newtons (N))
Time frame: 6 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.
Gait analysis is performed while using force-measuring insoles. Patients are asked to complete an parcours with the force-measuring insoles (stand up from a chair with armrests, walk 10 meters, turn, walk back and sit down again. Afterwards (if possible), 5 steps with a handrail should be climbed up and down.
Average peak load (Newtons (N))
Time frame: 12 weeks after full weight bearing is allowed for both 6 week early mobilization and SOC groups.
Gait analysis is performed while using force-measuring insoles. Patients are asked to complete an parcours with the force-measuring insoles (stand up from a chair with armrests, walk 10 meters, turn, walk back and sit down again. Afterwards (if possible), 5 steps with a handrail should be climbed up and down.
Average peak load (Newtons (N))
Time frame: 6 months after full weight bearing is allowed for both 6 week early mobilization and SOC groups.
Gait analysis is performed while using force-measuring insoles. Patients are asked to complete an parcours with the force-measuring insoles (stand up from a chair with armrests, walk 10 meters, turn, walk back and sit down again. Afterwards (if possible), 5 steps with a handrail should be climbed up and down.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
Related trials for Early Mobilization
Not yet recruiting
Segmental Thoracic vs Lumbar Spinal: Recovery After Elective Cesarean
Cesarean
Active, not recruiting
PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Critical Illness
Active, not recruitingObservational study
Adverse Events During Physical Therapy in Neurocritical ICU Patients
Critical Illness, Brain Injury
Recruiting
Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury II (PROMPT-SCI II) Trial
Spinal Cord Injuries, Spinal Cord Injury (SCI), Initial Encounter
Not yet recruiting
The Effect of Bedside Yoga Intervention on Early Mobilization in Children
Children, Yoga Therapy
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.
Justin Haller, M.D. principal investigator
University of Utah Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Mobilization, run by University of Utah at 1 site 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 5 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Average peak load (Newtons (N)) (time frame: 6 weeks for early mobilization group). The study lists 7 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 29 Apr 2026.