Clinical trial NCT02320682: Bone Metabolism Adjacent to Hip Prosthetic Surfaces. A Clinical F-PET/CT Study
Official title: Bone Metabolism Adjacent to Hip Prosthetic Surfaces. A Randomized Clinical F-PET/CT Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Osteo Arthritis
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2014-12-19
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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?

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: FEMUR: to analyze difference in SUV of the 4 upper ROI's (No 1, 7, 8 and 13) analyzed together between the two study groups AND: to analyze SUV of the 4 upper ROI's analyzed together between each femur study group and the reference group
timeFrame: 1 months after surgery
measure: ACETABULUM: to analyze difference in SUV of all 9 ROI's analyzed together between the two study groups (PF and TT), and to analyze SUV of all 9 ROI's analyzed together between each acetabulum prosthetic component study group and the reference group
timeFrame: 1 months after surgery
Secondary outcomes:
measure: FEMUR:to analyze difference in SUV for each individual ROI inbetween the cemented and uncemented femur group
timeFrame: 1, 4 and 9 months aftyer surgery
measure: FEMUR: to analyze difference in SUV for each individual ROI between the cemented study group and the reference group. To analyze difference in SUV for each individual ROI between the uncemented study group and the reference group.
timeFrame: 1, 4 and 9 months aftyer surgery
measure: FEMUR:to analyze difference in SUV for each individual ROI between the 3 time points for the cemented group. To analyze difference in SUV for each individual ROI between the 3 time points for the uncemented group.
timeFrame: 1, 4 and 9 months aftyer surgery
measure: FEMUR:to analyze difference in SUV for the 4 upper ROI's (No 1, 7, 8 and 13) analyzed together between the 2 study groups
timeFrame: 4 and 9 months aftyer surgery
measure: FEMUR:to analyze difference in SUV for the 4 upper ROI's analyzed together between each study group and the reference group
timeFrame: 4 and 9 months aftyer surgery
measure: ACETABULUM: to analyze difference in SUV for each individual ROI between the 2 study groups
timeFrame: 1, 4 and 9 months aftyer surgery
measure: ACETABULUM: to analyze difference in SUV for each individual ROI between the two study groups. To analyze difference in SUV for each individual ROI between each of the two study groups and the reference group.
timeFrame: 1, 4 and 9 months aftyer surgery
measure: ACETABULUM: to analyze difference in SUV for each individual ROI for the Delta PF study group between the 3 time points. To analyze difference in SUV for each individual ROI for the Delta TT study group between the 3 time points.
timeFrame: 1, 4 and 9 months aftyer surgery
measure: ACETABULUM: to analyze difference in SUV of all 9 ROI's analyzed together between the two acetabular study groups
timeFrame: 4 and 9 months aftyer surgery
measure: ACETABULUM: to analyze SUV of all 9 ROI's analyzed together between each acetabulum study group and the reference group
timeFrame: 4 and 9 months
Other outcomes:
measure: To analyze radiographic difference for each of the four study groups between direct postoperativ and 9 months postoperative radiographs.
timeFrame: Direct postoperative (1-3 days) and 9 months
measure: To analyze clinical score for the four study groups
timeFrame: preoperatively and 9 months postoperatively.
Locations:
city: Gävle,
country: Sweden
facility: Orthopaedic department Gävle hospital
Study officials:
affiliation: Orthopaedic department Gävle hospital, Gävle, Sweden and Centre for Research & Development Uppsala University/County Council of Gävleborg.
name: Gösta Ullmark, MD
role: PRINCIPAL_INVESTIGATOR
References: