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Bone Forming at Prosthetic Surfaces. Fingerprint2

NCT01623687 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2014-04-04

No results posted yet for this study

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?

Conditions

  • Osteo Arthritis

Interventions

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).

Sponsors & Collaborators

  • Uppsala University

    lead OTHER

Principal Investigators

  • Gösta Ullmark · Ass Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2014-09-30
Completion
2015-03-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01623687 on ClinicalTrials.gov