Kan topical bisfosfonat øge fiksation og overlevelseaf ucementeret knæledsprotese?Et prospektivt randomiseret migrations- og knogledensitetsstudie på tibia-implantater af trabeculært metal. - Knæprotese studie, topisk bisfosfonat

Conditions: Osteoarthritis of the knee treated with knee alloplastic
MedDRA version: 8.1Level: LLTClassification code 10031200Term: Osteoarthrosis, localized, primary, involving lower leg

Registration Number: EUCTR2006-003748-43-DK

Lead Sponsor: Ortopædkirurgisk Center, Aarhus Universitets Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Men and women with knee osteoarthrosis
2.Men and women with sufficient bonequality allowing knee alloplastics.
3.Older that 18 years and younger than 74 years. Duly qualified.
4.Written concent.

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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients with neuromuscular- or vascular diseases in the legs.
2. Patients whitch are peroperatively found not to be suited for
TKA.
3.Patients with osteoporosis verified with preoperative DEXA.
4.Patients with sequela after earlier knee fracture.
5.Patients with earlier major knee surgery.
6.Women who are pregnant or prone to pregnant within 5 times the
halftime of last given Ibandronic acid dose.
7.Patients with metabolic bonedisease.
8.Patients with rheumatoid arthritis.
9.Postmenopausale women treated with hormonal substitution.
10.Patients with a low creatinine-clearance (< 0,5 ml/s).
11.Patients with known hypocalcaemia.
12. Patients which are known allergic to ibandronic acid.
13. Patients undergoing intermittent or regular glucocorticoid treatment.
14. Patients with lactose intolerance (lactosis in tablets)
15. Patients with cancer.
16. Patients treated with radiotherapi or kemotherapi.
17. Patients with bad tooth status.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to estabilish whether topical- and systemic Ibandronic Acid increases the prosthetic fixation to the bone and increases the bone density close to the implant. Differences between the two adminitration ways is also evaluated.;Secondary Objective: ;Primary end point(s): 1: Bone mass density close to the implant assesed with DEXA scanning.<br>2: Prosthetic micromotion in the follow-up period.<br>

Secondary Outcome Measures