Bone Metabolism Adjacent to Hip Prosthetic Surfaces. A Clinical F-PET/CT Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2021-12-31

Brief Summary

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What is the intensity of F-PET uptake adjacent to four analyzed hip endoprosthetic components and in healthy femur and acetabulum, 1, 4 and 9 months after surgery?

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Detailed Description

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A clinical study of 32 patients, age 50-69 years, healthy unless osteoarthritis in one hip, randomized in two groups (16 each) plus a reference group of same 32 patient´s contralateral healthy hip.

Intervention will be surgery with a total hip arthroplasty. The four studied endoprosthetic components are:

* Cemented Exeter stem (Stryker Warsaw, USA) with a ceramic 32 mm head and Palacose cement with gentamycin, applied with 3:rd generation cementation technique.
* Uncemented Lubinus SP-CL stem (Waldemar Link, Hamburg, Germany) with a ceramic 32 mm head.
* Uncemented Delta PF cup (Limacorporate spa, Udine, Italy).
* Uncemented fibrous metal Delta TT cup (Limacorporate spa, Udine, Italy). Both cups will have cross linked Ultra-high-molecular-weight polyethylene (UHWMP).

Clinical score, radiography and uptake of Fluoride tracer will be analyzed.

Conditions

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Hip Osteo Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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