Prosthetic migration in uncemented total hip replacement
Conditions
Interventions
Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion
INN or Proposed INN: ZOLEDRONIC ACID
CAS Number: 118072-93-8
Concentration unit: mg/ml milligram(s)/millilitre
Co
Sponsors
Region Östergötland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients 50-70 years of age with osteoarthritis of the hip in need of hip replacement. Written informed consent to participate in the study is required. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Abnormal configuration of the acetabulum or femur making implantation of the study implants unfeasible • Previous or present use of bisphosphonates or other antiresorptives • Prevalent use of other drugs, which influence bone, or use less than a year before randomization. ? Drugs with the following ATC codes will lead to exclusion of the patient o Antiepileptic drugs: N03AG, N03AF, N03AA, N03AB, N03AC, o Strontium: M05BX03 o Denosumab: M05BX04 o Parathyroid hormone: H05 o Corticosteroids (with a dosage equivalent to more than 5mg prednisolone) : H02 • Present use of nephrotoxic medication • Active malignant disease • Previous radiation therapy of the hip or pelvis • Metabolic disease (other than osteoporosis) affecting the skeleton • Rheumatic disease • Hypocalcemia as defined by local lab criteria (assessment is clinical routine) • Simultaneous bilateral surgery • Communication problems (drug abuse, language or behavior problems) • Creatinine clearance (GFR) <35 mL/min (assessment is clinical routine) • Expected follow-op period less than 3 years (e.g. due to uncontrolled malignancy) • Expected to require special postoperative surveillance due to increased surgical risk (e.g. for cardiac, psychiatric condition) • Participation in another clinical trial involving medication within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the effect of local zoledronate on migration of an uncemented acetabular cup at 2 years postop as measured by RSA (Radiostereometric analysis) The measurement technique used will be maximum total point motion (MTPM).;Secondary Objective: Secondary objectives are to find if local treatment of the bone bed with zoledronate immediately before insertion will lead to: Reduced migration of an uncemented stem at 2 years postop as measured by RSA. Reduced migration of an uncemented stem between 3 months and 2 years postop. Fewer patients exhibiting radiolucent zones around the cup at 2 years postop. Other secondary objectives are changes in HHS and HOOS from baseline to 2 years. ;Primary end point(s): Differences in cup migration from baseline until 2 years as measured with radiostereometric analysis is the primary endpoint. These differences will be evaluated with parametric tests after log transformation of MTPM values. ;Timepoint(s) of evaluation of this end point: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Differences in migration of an uncemented stem at 2 years postop as measured by RSA (MTPM). - Differences in migration of an uncemented stem between 3 months and 2 years postop. - Differences in the frequency of radiolucent zones around the cup at 2 years postop. Differences in changes of HHS and HOOS from baseline to 2 years ;Timepoint(s) of evaluation of this end point: 2 years | — |
Countries
Sweden
Contacts
Public ContactJörg Schilcher
Region Östergötland
Outcome results
None listed