Humerus Fracture Displaced Proximal
Conditions
Keywords
large bone defect, bone marrow-derived mononuclear cells
Brief summary
In the present phase-II clinical trial the researchers investigate efficacy and proof of concept of the augmentation with preoperatively isolated autologous BMC cells seeded onto ß-TCP in combination with an angle stable fixation (Philos plate®) for the therapy of proximal humeral fractures.
Interventions
BIOLOGICALBMC2012
DEVICEbeta-TCP Chronos® Synthes
Sponsors
LOEWE CGT
Goethe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* patients aged between 50. and 90. years with proximal humerus fractures * indication for open reposition and internal stabilisation with a proximal fixed- angle plate for humerus (PHILOS, Synthes, Oberdorf, Swiss): * 2-, 3- or 4-fragment fracture according to Neer * dislocation of \>10 mm between fragments and/or * angle of \> 45° between fragments and/or * dislocation of tuberculum majus \> 5 mm * negative pregnancy test of premenopausal women * signed informed consent for surgery and participation in the clinical trial
Exclusion criteria
* contraindications against administration of Investigational medicinal product (IMP) is pregnancy and nursing * dislocation fracture * known psychic disorder that leads to incompliance (e.g. dementia, schizophrenia, major depression) * pathologic fractures caused by other underlying diseases * fracture-induced nerve damage * tumor disease with recent adjuvant therapy or treatment during the last 3 months (e.g. chemotherapy, radiotherapy), untreated tumor diseases * known hypersensibility against components of the transplant * participation in a clinical trial during the last 3 months prior to this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Secondary dislocation of fracture | 12 weeks | Secondary dislocation is diagnosed on plain radiographs, if more than 20° varus collapse of the humeral head fragment in relation to the humeral shaft and / or screw penetration through the humeral head is detected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome after fixation | 12 weeks | Functional outcome after fixation will be recorded by the Dash-Score at week 12; assessment of safety: all adverse reactions will be recorded and analyzed. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Concomitant medication | day -1 | Documentation of concomitant medication |
| Adverse events | day -1 | Documentation of adverse events |
| Degree of bony bridging (percent of defect area) in the bone fracture | week 1 | Analysis of fracture healing by radiologic evaluation, consolidation, necrosis |
Countries
Germany
Outcome results
None listed