NCT01623687

Bone Forming at Prosthetic Surfaces. Fingerprint2

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 50 Years – 69 Years
• Healthy volunteers: Not accepted

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?

Detailed 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.

Conditions

• Osteo Arthritis

Interventions

Type	Name	Description
DEVICE	Component for acetabulum (Regenerex RingLoc cup)	A fibrous metal uncemented Regenerex RingLoc cup (Biomet, Warsaw, Il, USA)
DEVICE	Components for the acetabulum (Lubinus cross linked cup)	cemented Lubinus cross linked cup (Waldemar Link, Hamburg, Germany).
DEVICE	Arthroplasty components are for the femur (Cemented Lubinus SP II stem)	Cemented Lubinus SP II stem (Waldemar Link, Hamburg, Germany) with a ceramic 32 mm head.
DEVICE	Arthroplasty components are for the femur (Corail stem)	Uncemented HA-coated Corail stem with a ceramic 32 mm head (DePuy, Johnsson \& Johnsson, USA).

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-09-01
• Completion: 2015-03-01
• First posted: 2012-06-20
• Last updated: 2014-04-04

Locations

1 site across 1 country: Sweden