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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514903-33-00

Enrollment

107

Registered

2024-07-10

Start date

2014-01-12

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

Osteoarthritis in the knee treated with cementless total knee arthroplasty

Brief summary

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).

Detailed description

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

Interventions

DRUGZoledronic Acid Fresenius Kabi 4 mg/5 ml koncentrat till infusionsvätska

DRUGlösning

DRUGSODIUM CHLORIDE

DRUGProlia 60 mg solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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).	—

Secondary

Measure	Time frame
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	—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026