A 4-way randomized double-blinded migration (RSA), bone density (DXA), and biomarker study assessing adaptive bone changes and implant fixation and longevity of the new Regenerex Porous Titanium Tibial Tray with different adjuvant medical therapies.
interventional
N/A
1 country
1
Investigate the possibility to improve immediate and long term fixation of cementless tibial components of total knee arthroplasty by use of adjuvant treatment by denosumab or topical zoledronic acid through assessment of implant migration in relation to the bone by radiostereophotogrammetric analysis (RSA) and assessment of bone mineral density changes in the periprosthetic bone as measured by dual energy x-ray absorptiometry (DXA). H1: Tibial components are more stable (RSA) in the intervention groups receiving active substances (denosumab s.c. injection or topical zoledronic acid) compared to placebo.
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June 21, 2024
Actual (reported)Implant migration (RSA) measured continuously from baseline to followup (MTPM) and estimation of Continuous MTPM (MTPM migration > 0.2 mm between 12 and 24 months of follow-up) according to Ryd et al. (Ryd et al., 1995).
DXA - Changes in Bone Mineral Density under the Tibial Tray and in proximity of the central stem.
Biomarkers - Bone resorption from baseline to follow-ups and correlation between bone density changes, biomarkers of bone resorption and implant migration
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Formulated product
Prolia 60 mg solution for injection in pre-filled syringe
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SOLUTION FOR INJECTION
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Prolia 60 mg solution for injection in pre-filled syringe
Named ingredient: Denosumab
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Aarhus Universitetshospital
Aarhus N, 8200, Denmark
Department of Orthopedics
First Submitted
June 21, 2024
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