Bone Forming at Prosthetic Surfaces. Fingerprint2

Uppsala University

Status and phase: Unknown; Phase 4

Conditions: Osteo Arthritis

Treatments: Device: Arthroplasty components are for the femur (Corail stem); Device: Components for the acetabulum (Lubinus cross linked cup); Device: Arthroplasty components are for the femur (Cemented Lubinus SP II stem); Device: Component for acetabulum (Regenerex RingLoc cup)

Study type: Interventional

Funder types: Other

Identifiers

NCT01623687

GUllmark Apr -12

Details and patient eligibility

About

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?

Full 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.

Enrollment: 26 estimated patients

Sex: All

Ages: 50 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients diagnosed to have unilateral hip osteo arthritis (Charnley group A) aimed for THA at the orthopedic clinic Gävle hospital.

Exclusion criteria

• Systemic disease or medication affecting the skeleton

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 4 patient groups

Regenerex

Active Comparator group

Treatment:

Device: Component for acetabulum (Regenerex RingLoc cup)

Lub cup

Active Comparator group

Treatment:

Device: Components for the acetabulum (Lubinus cross linked cup)

SP II

Active Comparator group

Treatment:

Device: Arthroplasty components are for the femur (Cemented Lubinus SP II stem)

Corail

Active Comparator group

Treatment:

Device: Arthroplasty components are for the femur (Corail stem)