Smart Implants 2.0 – Weight-bearing and Gait Observation for Early Monitoring of Fracture Healing and Individualized Therapy after Trauma

Recruiting

Conditions: S82
S42
S32
Fracture of lower leg, including ankle
Fracture of shoulder and upper arm
Fracture of lumbar spine and pelvis

Registration Number: DRKS00025108

Lead Sponsor: niversitätsklinikum des SaarlandesKlinik für Unfall-, Hand- und Wiederherstellungschirurgie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 50

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

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.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Radiographic Union Score Tibia und Hip (RUST/RUSH Score) zum Follow-Up<br>- Patient-related functional outcome scores:<br>o Patient Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) / Pain Interference (PAIN INT)<br>o Hip Disability and Osteoarthritis Outcome Score [HOOS] <br>o Knee Injury and Osteoarthritis Outcome Score [KOOS]<br>o Foot and Ankle Ability Measure [FAAM]<br>o quick Disability of the Arm, Shoulder and Hand Score [quick-DASH]<br>Dynamic gait analysis<br>- Number of steps with or above 80% body weight<br>- Plantar pressure distribution<br>- Centre of Pressure of the foot<br>- Resulting ground reaction forces<br>- Gait analysis (time, stance phase, swing phase, gait cycle etc.)<br>- Motion capturing (joint angles)<br>- Blood flow measurements in the fracture gap (SO2, Hb, blood flow).

Secondary Outcome Measures

Name	Time	Method
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