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

gosta ullmark

Status: Unknown

Conditions: Hip Osteo Arthritis

Treatments: Device: Surgery for Total Hip Arthroplasty (THA)

Study type: Interventional

Funder types: Other

Identifiers

NCT02320682

Fingerprint III

Details and patient eligibility

About

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?

Full description

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 50 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients diagnosed to have unilateral hip osteo arthritis verified by radiography (Charnley group A) aimed for THA at Gävle hospital and accepting to participate in the study.

Exclusion criteria

• any systemic disease (other than osteo arthritis) or medication affecting skeleton methabolism

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Exeter femur component and Delta TT acetabular component

Active Comparator group

Treatment:

Device: Surgery for Total Hip Arthroplasty (THA)

SP-CL femur component and Delta TT acetabular component

Active Comparator group

Treatment:

Device: Surgery for Total Hip Arthroplasty (THA)

SP-CL femoral component and Delta PF acetabular component

Active Comparator group

Treatment:

Device: Surgery for Total Hip Arthroplasty (THA)

Exeter femoral component and Delta PF acetabular component

Active Comparator group

Treatment:

Device: Surgery for Total Hip Arthroplasty (THA)