Actively Recruiting
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal Tibia Fractures
Led by Comeback Mobility Inc · Updated on 2026-04-14
30
Participants Needed
18
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn whether personalized weight-bearing prescriptions using Smart Crutch Tips™ can improve recovery after surgery for extra-articular distal tibia fractures. The study will also assess how safe and practical this approach is in daily outpatient use. Can a personalized weight-bearing program based on CT and finite element analysis help the fracture heal faster? Can it help patients return to full weight-bearing sooner? Can it reduce the fear of movement during recovery? Researchers will compare standard rehabilitation, AO Foundation-based recommendations, and personalized weight-bearing programs derived from finite element analysis (FEA) to determine which approach leads to faster healing, earlier mobility, and better outcomes. Participants will: Use Smart Crutch Tips™ during walking for up to 24 weeks; Follow a personalized weight-bearing prescription based on CT scans and biomechanical modeling; Follow a specific walking plan with real-time audio and visual feedback; Attend eight follow-up visits over 36 weeks for clinical exams, x-rays, and CT scans; Complete online questionnaires about pain, activity, and fear of movement.
CONDITIONS
Official Title
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal Tibia Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent after full information about the study
- Age between 18 and 80 years, both males and pre-menopausal females
- Body weight between 40 and 120 kg
- Diagnosed with a closed tibial shaft fracture (AO/OTA 43-1, 43-2, 43-3) needing surgery
- Fracture treated only with plates and/or intramedullary nail
- No diabetes or well-controlled diabetes (HbA1c 64 7.0%)
- Able to use crutches without losing balance and medically cleared for partial weight-bearing on operated leg
- Willing to follow prescribed weight-bearing protocol using Smart Crutch Tips12
- Enrollment within 48 hours after surgery
- Alcohol consumption within acceptable limits (up to 2-3 times per week)
- Willing to comply with all study procedures and follow-up visits
- Patients with stable fractures extending into distal tibial epiphysis articular surface may be included
You will not qualify if you...
- Open or high-energy fractures, multiple lower-limb fractures, or use of bone grafts
- Fractures classified as 41-A, 41-B, or 42-A,B by AO/OTA
- Chronic alcoholism (>14 drinks/week for men or >7 for women)
- Metabolic disorders like uncontrolled thyroid dysfunction, severe kidney or liver disease
- Pathological fractures from osteoporosis, infections, tumors, metastases, or rickets
- Lower-limb contractures with grade II or higher functional impairment
- Pregnancy or planning pregnancy during the study
- Psychiatric, cognitive, or neurological disorders affecting rehabilitation or communication
- Significant heart failure (ejection fraction <40% or symptoms like edema, breathlessness at rest)
- Lung insufficiency with chronic low oxygen or high carbon dioxide requiring oxygen or limiting activity
- Neurological disorders affecting motor function or coordination (e.g., stroke, Parkinson's)
- Epilepsy or seizures not fully controlled by medication
- Progressive neurodegenerative diseases (e.g., ALS, Huntington's, dementia)
- Sensory, balance, or vestibular disorders impairing safe device use
- Participation in another clinical trial within past 6 months that may affect results
- Current or planned use of medications that affect bone healing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Kyiv City Clinical Hospital No. 1
Kyiv, Kyiv Oblast, Ukraine, 02091
Actively Recruiting
2
Municipal Clinical Hospital No. 4 of the Dnipro City Counci
Dnipro, Ukraine, 49102
Actively Recruiting
3
Communal Non-Profit Enterprise "Regional Family Health Medical Center" of the Dnipropetrovsk Regional Council
Dnipro, Ukraine
Actively Recruiting
4
Municipal Non-Profit Enterprise "City Clinical Hospital No. 16" of the Dnipro City Council
Dnipro, Ukraine
Actively Recruiting
5
Municipal Non-Profit Enterprise of the Dnipro Regional Council "Dnipro Regional Clinical Hospital named after Mechnikov"
Dnipro, Ukraine
Actively Recruiting
6
University Hospital of the Dnipro State Medical University
Dnipro, Ukraine
Actively Recruiting
7
Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Clinical Hospital of the Ivano-Frankivsk Regional Council"
Ivano-Frankivsk, Ukraine
Actively Recruiting
8
Kyiv City Clinical Hospital No. 17
Kyiv, Ukraine, 01133
Not Yet Recruiting
9
Institute of Traumatology and orthopedics of the national academy of medical sciences of Ukraine
Kyiv, Ukraine, 01601
Not Yet Recruiting
10
Kyiv City Clinical Hospital No. 12
Kyiv, Ukraine, 02000
Not Yet Recruiting
11
Kyiv City Clinical Hospital No. 6
Kyiv, Ukraine, 03126
Not Yet Recruiting
12
Kyiv City Clinical Hospital No. 7
Kyiv, Ukraine, 03179
Actively Recruiting
13
Kyiv Regional Council "Kyiv Regional Clinical Hospital"
Kyiv, Ukraine, 04106
Not Yet Recruiting
14
Kyiv City Clinical Hospital No. 9
Kyiv, Ukraine, 04112
Actively Recruiting
15
Kyiv City Clinical Hospital No. 8
Kyiv, Ukraine, 04201
Actively Recruiting
16
State Institution "Feofaniya Clinical Hospital of the State Administration of Affairs"
Kyiv, Ukraine
Actively Recruiting
17
Municipal Non-Profit Enterprise "Lviv Territorial Medical Association" "Multidisciplinary Clinical Hospital for Intensive Treatment Methods and Emergency Medical Care"
Lviv, Ukraine
Actively Recruiting
18
Municipal Non-Profit Enterprise "Lviv Territorial Medical Association" "Multidisciplinary Clinical Hospital for Intensive Treatment Methods and Emergency Medical Care"
Lviv, Ukraine
Actively Recruiting
Research Team
N
Nataliia POPOVA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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