S82 S42 S32
Conditions
Interventions
Group 1: Patients with fractures of the tibia or the lower leg after surgery will be monitored with insoles (that measure ground-reaction forces) and motion sensors, as well as motion capturing and EM
Sponsors
Universitätsklinikum des SaarlandesKlinik für Unfall-, Hand- und Wiederherstellungschirurgie
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: Adults, able to give written consent, tibia fracture (either surgery or conservative treatment), fracture types AO Typ 42 & 43 A1 to C3 or femur fractures (AO Typ 31/32/33 A1 to C3), that allow for immediate weight bearing.
Exclusion criteria
Exclusion criteria: Younger than 18 years, immobility already before the fracture event, use of walking aid prior to the fracture, unability to give consent, further injuries of the lower extremities in addition to the fractures named under inclusion criteria, unability to handle the study (mobile phone usw etc.), alcohol or drug abuse, pregnancy, convicts, participation in another ongoing clinical study, or within the past month or less.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Radiographic Union Score Tibia und Hip (RUST/RUSH Score) zum Follow-Up - Patient-related functional outcome scores: o Patient Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) / Pain Interference (PAIN INT) o Hip Disability and Osteoarthritis Outcome Score [HOOS] o Knee Injury and Osteoarthritis Outcome Score [KOOS] o Foot and Ankle Ability Measure [FAAM] o quick Disability of the Arm, Shoulder and Hand Score [quick-DASH] Dynamic gait analysis - Number of steps with or above 80% body weight - Plantar pressure distribution - Centre of Pressure of the foot - Resulting ground reaction forces - Gait analysis (time, stance phase, swing phase, gait cycle etc.) - Motion capturing (joint angles) - Blood flow measurements in the fracture gap (SO2, Hb, blood flow). | — |
Secondary
| Measure | Time frame |
|---|---|
| Computer simulations of bone deformation: Which forces at the fracture site improve healing and which do not. Prediction of healing problems via gait pattern and via blood flow in the fracture gap | — |
Countries
Germany
Contacts
Public ContactAynur Götken
Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinikum des Saarlandes
Outcome results
None listed