Methods against Non-Union: From Grassroots to Clinical Application – Sub-project "Therapeutic Strategies in Pre-clinical Animal Models"

Status:

ongoing

Aims:

MaNGA-TsT deploys a standardised rat non-union model as a pre-clinical filter to systematically assess combinations of ceramic bone-graft substitutes (Cerament^® G) or autologous cancellous bone grafts with osteostimulatory adjuvants (BMP-2, zoledronic acid, parathyroid hormone). The strategic objective is to advance to clinical use only those therapeutic regimens that demonstrably accelerate bone healing without relevant toxicity, thereby delivering a superior benefit-risk profile for patients.

Activities/Methods:

Using a two-stage critical-size femoral defect model in Sprague-Dawley rats, 19 treatment arms are benchmarked. Primary endpoint is torsional strength; secondary metrics include μCT bone volume, histological remodelling, vascularisation and serum biomarkers. An adaptive, double-blinded design and full ARRIVE/GCP compliance ensure translational robustness.

Expected Outcomes / Impact
The study will delineate effective and safe osteostimulative combinations, define therapeutic windows and help to generate a data package for early-phase human trials. Anticipated downstream effects are fewer revision surgeries, shorter time-to-work and substantial cost savings in the management of aseptic or septic non-unions – directly supporting DGUV’s prevention and rehabilitation mandate.

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