bone fracture in patients identified as being at high risk of impaired fracture healing based on elevated pre-operative CD8+ T effector memory cells re-expressing CD45RA (TEMRA) levels
Conditions
Brief summary
Radiological fracture healing at Week 18 assessed by CT
Detailed description
Radiological fracture healing at Week 18 and Week 36 (RUSH, mRUST, X-ray), Patient-reported outcomes at week 6, 18, 36, 52 (VAS pain score, EQ-5D-5L, SMFA, Return-to-work status), Incidence, severity and relationship of AEs graded according to NCI-CTCAE V6.0
Interventions
Sponsors
Charite Universitaetsmedizin Berlin KöR
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiological fracture healing at Week 18 assessed by CT | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiological fracture healing at Week 18 and Week 36 (RUSH, mRUST, X-ray), Patient-reported outcomes at week 6, 18, 36, 52 (VAS pain score, EQ-5D-5L, SMFA, Return-to-work status), Incidence, severity and relationship of AEs graded according to NCI-CTCAE V6.0 | — |
Outcome results
None listed