Osteoarthritis in the knee treated with cementless total knee arthroplasty MedDRA version: 16.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Zoledronic Acid (Zoledronsyre)
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ZOLEDRONIC ACID MONOHYDRATE
CAS Number: 165800-06-6
Other descriptive name: ZOLEDRONIC ACID M
Sponsors
ORtopædkirurgisk Forskningsenhed, Aarhus Universitetshospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 95 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - neuromuscular or vascular disease in the affected leg - 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 - renal failure (GFR 14, men > 21 units/week)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: H2: The periprostetic bone is better conserved in proximity of tibial components when adjuvant treatment by denosumab or zoledronic acid is used as compared to placebo. H3: Adjuvant treatment by denusomab will result in a systemic response whereas treatment with topical zoledronic acid and placebo will not result in a systemic response as measured by bone formation markers.;Primary end point(s): Implant migration (RSA) measured continuously from baseline to follow-up (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). ;Timepoint(s) of evaluation of this end point: First patient, first visit June 2013. Last Patient, last visit November 2025. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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 ;Timepoint(s) of evaluation of this end point: First patient, first visit June 2013. Last Patient, last visit November 2025. | — |
Countries
Denmark
Contacts
Public ContactMaiken Stilling
Ortopædkirurgisk Forskningsenhed
Outcome results
None listed