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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00010872

Enrollment

800

Registered

2016-07-26

Start date

2016-12-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

S82.1 S82.2 S82.3 S82.7 S82.11 S82.18 S82.31 S72 S72.1 S72.2 S72.3 S72.4 S72.7 S72.8

Interventions

Group 1: We pre-surgery assess the CD8+TEMRA cell expression in all long bone fracture patients treated with an osteosynthesis. Within the post-surgery clinical routine visits, the healing Status of t

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactSimon Reinke

Charité UniversitätsmedizinBerlin / Berlin-Brandenburger Centrum für Regenerative Therapien / Julius Wolff Institut

simon.reinke@charite.de+4930450659617

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026