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

Hip Osteo Arthritis Clinical Trial

— Fp-III  

Official title:

Bone Metabolism Adjacent to Hip Prosthetic Surfaces. A Randomized Clinical F-PET/CT Study.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02320682
• Other study ID #: Fingerprint III
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 2014
• Est. completion date: December 2021

Study information

• Verified date: May 2018
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 32
• Est. completion date: December 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteo Arthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• Surgery for Total Hip Arthroplasty (THA)
THA surgery where four prosthetic components will randomly be inserted. Randomly an Exeter or SP-CL femur component will be combined with randomly a Delta TT or Delta PF acetabular component.

Locations

Country	Name	City	State
Sweden	Orthopaedic department Gävle hospital	Gävle,

Sponsors (1)

Lead Sponsor	Collaborator
gosta ullmark

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To analyze radiographic difference for each of the four study groups between direct postoperativ and 9 months postoperative radiographs.		Direct postoperative (1-3 days) and 9 months
Other	To analyze clinical score for the four study groups	Merle d Merle d´Aubignè and Postel score	preoperatively and 9 months postoperatively.
Primary	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	There are two study groups for femur: cemented and uncemented femur prosthetic components. There is also a femur reference group.	1 months after surgery
Primary	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	There are two study groups for acetabulum: two models of uncemented acetabular prosthetic components. There is also an acetabular reference group.	1 months after surgery
Secondary	FEMUR:to analyze difference in SUV for each individual ROI inbetween the cemented and uncemented femur group		1, 4 and 9 months aftyer surgery
Secondary	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.		1, 4 and 9 months aftyer surgery
Secondary	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.		1, 4 and 9 months aftyer surgery
Secondary	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		4 and 9 months aftyer surgery
Secondary	FEMUR:to analyze difference in SUV for the 4 upper ROI's analyzed together between each study group and the reference group		4 and 9 months aftyer surgery
Secondary	ACETABULUM: to analyze difference in SUV for each individual ROI between the 2 study groups		1, 4 and 9 months aftyer surgery
Secondary	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.		1, 4 and 9 months aftyer surgery
Secondary	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.		1, 4 and 9 months aftyer surgery
Secondary	ACETABULUM: to analyze difference in SUV of all 9 ROI`s analyzed together between the two acetabular study groups		4 and 9 months aftyer surgery
Secondary	ACETABULUM: to analyze SUV of all 9 ROI`s analyzed together between each acetabulum study group and the reference group		4 and 9 months