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The impact of local bisphosphonate treatment on prosthetic fixation

The impact of local bisphosphonate treatment on prosthetic fixation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-014414-98-SE
Enrollment
Unknown
Registered
2009-09-01
Start date
2009-10-29
Completion date
Unknown
Last updated
2016-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the hip joint treated with total hip replacement

Interventions

Trade Name: Bonviva Product Name: Bonviva Pharmaceutical Form: Spot-on solution CAS Number: 0 Other descriptive name: IBANDRONIC ACID MONOSODIUM SALT, MONOHYDRATE Concentration unit: mg/ml milligram(s

Sponsors

Department of Orthopaedic Surgery University Hospital Linköping
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients 50-65 years of age with primary osteoarthritis of the hip that are planned for total hip arthroplasty. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Osteoporosis. Treatment with coticosteroids. Treatment with drugs that influence bone metabolism e.g.bisphosphonates, cytostatic drugs, anticonvulsive drugs. Osteomalacia, malignant disease, bonemetastases, osteogenesis imperfecta, dysplastic fibrosis, hyperparathyroidisim, hyperthyroidism, abnormal kidney function defined as elevated serum-kreatinin. Liver failure. Gastric ulceration within the last year.

Design outcomes

Primary

MeasureTime frame
Main Objective: To Investigate if local treatment of the bonebed with bisphosphonate solution prior to fixation of the acetabular component of a cemented hip prosthesis decreases the risk for future loosening of the prosthesis.;Secondary Objective: ;Primary end point(s): Local treatment of the acetabular bone bed with bisphosphonate drugs results in less resorption of the periprosthetic bone and consequently in a more stabile fixation. End Point: Radiostereometric Analysis at 2 years post surgery.

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026