Prospective validation of the prognostic biomarker CD8+ TEMRA cells for disturbed fracture healing.

Recruiting

Conditions: S82.1
S82.2
S82.3
S82.7
S82.11
S82.18
S82.31
S72
S72.1
S72.2

Registration Number: DRKS00010872

Lead Sponsor: Charité Universitätsmedizin Berlin / Berlin-Brandenburger Centrum für Regenerative Therapien / Julius Wolff Institut

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 800

Inclusion Criteria

full Age (18+),
contractually capable,
patient who understand the informed consent + signed consent,
fracture of the Long bones,
surgery Treatment = osteosynthesis,
patient was mobilised before the fracture/surgery occured

Exclusion Criteria

periprothetic fractures,
pathological fractures,
active Tumor disease,
active Tumor therapy/Treatment,
HIV, Hepatitis B and/or C positive,
drug-dependent person
psyschological disease,
pregnant or nursing Person,
participation in another, parallel running interventional study

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fracture healing status 18 weeks post surgery.<br>Radiogical analyses to assess the size of the fracture gap and the implant stability as well as functional tests.<br>Definition of a delayed healing based on the radiological criteria:<br>a) An incomplete fracture healing or the absence of visible bone consolidation.<br>b) The presence of a resorption zone or incomplete callus formation.<br>c) An incomplete bridging, which means one to three cortices bridged. <br>d) No bridging, which means no cortex is bridged<br>

Secondary Outcome Measures

Name	Time	Method
fracture healing status 36 weeks post surgery.<br>Radiological analyses to assess the size of the fracture gap, the bone consolidation and the implant stability as well as functional tests.<br><br>The definition of a non-union is fullfilled if the patient meet one or more of the following criteria: <br>a) no fracture consolidation within 9 months following injury. <br>b) no signs of fracture consolidation over a three-month period<br>c) no signs of fracture consolidation within 5 months after initial surgery in the event of implant failure