BridgeMD
RGX
EU CTIS ID: 2024-514903-33-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- primary knee osteoarthritis in capable men and women
- sufficient bone quality for total cruxiate retaining knee arthroplasty
- age above 18 years but maximum 75 years of age
- informed and written consent
You likely can't join if
- neuromuscular or vascular disease in the affected leg
- renal failure (GFR < 30 ml/min)
- persistent hypocalcaemia
- allergic to bisphosphonate or denusomab
- sporadic or permanent need of systemic glucocorticoid treatment
- active cancer
See the full eligibility criteria
- primary knee osteoarthritis in capable men and women
- sufficient bone quality for total cruxiate retaining knee arthroplasty
- age above 18 years but maximum 75 years of age
- informed and written consent
- neuromuscular or vascular disease in the affected leg
- renal failure (GFR < 30 ml/min)
- persistent hypocalcaemia
- allergic to bisphosphonate or denusomab
- sporadic or permanent need of systemic glucocorticoid treatment
- active cancer
- radiation or chemotherapy
- poor dental status (increased risk of jaw-necrosis with bisphosphonates/denusomab)
- high use of alcoholic beverages (women > 14, men > 21 units/week)
- peroperatively found to be unsuitable for a primary knee arthroplasty
- osteoporosis based on former diagnosis or preoperative DXA-scan
- fracture sequelae or previous PTO or previous extensive knee surgery
- need for a stem-elongation
- NSAID postoperatively
- pregnancy (positive pregnancy test) or at risk of becoming pregnant during the project (not using safe anti-conceptive agents like contraceptive pills, intra-uterine device (IUD), hormone depot injection, subdermal implantation of a contraceptive rod, hormone vaginal ring, transdermal depot hormone sticking plaster)
- metabolic bone disease
- rheumatoid arthritis
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.