Bone Forming at Prosthetic Surfaces. Fingerprint2

Osteo Arthritis Clinical Trial

Official title: Bone Forming at Prosthetic Surfaces. A Randomized Clinical F-PET/CT Study

Status Recruiting

Clinical Trial Summary

What is the intensity of F-PET uptake in healthy and osteo arthritic femur and acetabulum, compared to the uptake adjacent to four analyzed endoprosthetic components 1½ and 6 months after surgery?

Clinical Trial Description

A clinical study of 26 patients, age 50-69 years, healthy unless osteoarthritis in one hip, randomized in four groups plus a reference group of same 26 patient´s contralateral healthy hip.

Intervention will be surgery with a total hip arthroplasty. The studied endoprosthetic components are: Cemented Lubinus SP II stem with a ceramic 32 mm head, a cemented Lubinus cross linked cup (Waldemar Link, Hamburg, Germany). Palacose cement with gentamycin, applied with 3:rd generation cementation technique will be used for those cemented implants.

Uncemented HA-coated Corail stem with a ceramic 32 mm head (DePuy, Johnson & Johnson, USA), a fibrous metal Regenerex RingLoc cup (Biomet, Warsaw, Il, USA) All cups will have cross linked Ultra-high-molecular-weight polyethylene (UHWMP).

Clinical score, radiography and PET uptake of Fluoride tracer (SUV) adjacent to the prosthetic surfaces will be analyzed. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteo Arthritis
• Osteoarthritis

• NCT number: NCT01623687
• Study type: Interventional
• Source: Uppsala University
• Contact: Gösta Ullmark, MD, PhD
• Phone: +46706466149
• Email: gosta.ullmark@lg.se
• Status: Recruiting
• Phase: Phase 4
• Start date: August 2011
• Completion date: March 2015