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

G

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)

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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