Clinical trial NCT01623687: Bone Forming at Prosthetic Surfaces. Fingerprint2
Official title: Bone Forming at Prosthetic Surfaces. A Randomized Clinical F-PET/CT Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteo Arthritis
Keywords: total hip arthroplasty
bone metabolism
mineralisation
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2012-06-20
Enrollment: 26
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 in healthy and osteo arthritic femur and acetabulum, compared to the uptake adjacent to four analyzed endoprosthetic components 1½ and 6 months after surgery?

Detailed 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.

Eligibility criteria: 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

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 cemented and uncemented groups AND: to analyze SUV of the 4 upper ROI's analyzed together between each femur study group and the reference group
timeFrame: 6 weeks after surgery
measure: ACETABULUM: to analyze difference in SUV of all 9 ROI's analyzed together between the cemented and uncemented acetabular study groups, and to analyze SUV of all 9 ROI's analyzed together between each acetabulum study group and the reference group
timeFrame: 6 weeks after surgery
Secondary outcomes:
measure: FEMUR:to analyze difference in SUV for each individual ROI inbetween the cemented and uncemented femur group
timeFrame: 6 weeks and 6 months
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: 6 weks and 6 months
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: preoperatively, 6 weeks and 6 months
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: 6 months
measure: FEMUR:to analyze difference in SUV for the 4 upper ROI's analyzed together between each study group and the reference group
timeFrame: 6 months
measure: ACETABULUM: to analyze difference in SUV for each individual ROI between the 2 study groups
timeFrame: 6 weeks and 6 months
measure: ACETABULUM: 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: 6 weeks and 6 months
measure: ACETABULUM: to analyze difference in SUV for each individual ROI for the cemented study group between the 3 time points. To analyze difference in SUV for each individual ROI for the uncemented study group between the 3 time points.
timeFrame: preoperatively, 6 weeks and 6 months
measure: ACETABULUM: to analyze difference in SUV of all 9 ROI's analyzed together between the cemented and uncemented acetabular study groups
timeFrame: 6 months
measure: ACETABULUM: to analyze difference in SUV of all 9 ROI's analyzed together between the cemented and uncemented acetabular study groups, and to analyze SUV of all 9 ROI's analyzed together between each acetabulum study group and the reference group
timeFrame: 6 months
Other outcomes:
Locations:
city: Gävle
country: Sweden
facility: Centre for research and development Uppsala university/County council of Gävleborg
Study officials:
affiliation: Ass Professor
name: Gösta Ullmark
role: STUDY_CHAIR
References:
citation: Ullmark G, Sorensen J, Nilsson O, Maripuu E. Bone mineralisation adjacent to cemented and uncemented acetabular cups: analysis by [18F]-fluoride-PET in a randomised clinical trial. Hip Int. 2020 Nov;30(6):745-751. doi: 10.1177/1120700019861274. Epub 2020 Jul 19.
citation: Ullmark G, Sorensen J, Maripuu E, Nilsson O. Fingerprint pattern of bone mineralisation on cemented and uncemented femoral stems: analysis by [18F]-fluoride-PET in a randomised clinical trial. Hip Int. 2019 Nov;29(6):609-617. doi: 10.1177/1120700018815404. Epub 2018 Dec 6.