Bone Forming at Prosthetic Surfaces. Fingerprint2

Osteo Arthritis Clinical Trial

Official title:

Bone Forming at Prosthetic Surfaces. A Randomized Clinical F-PET/CT Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01623687
• Other study ID #: GUllmark Apr -12
• Status: Recruiting
• Phase: Phase 4
• First received: January 17, 2012
• Last updated: April 3, 2014
• Start date: August 2011
• Est. completion date: March 2015

Study information

• Verified date: April 2014
• Source: Uppsala University
• Contact: Gösta Ullmark, MD, PhD
• Phone: +46706466149
• Email: gosta.ullmark[@]lg.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: March 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteo Arthritis
• Osteoarthritis

Intervention

Device:
• Component for acetabulum (Regenerex RingLoc cup)
A fibrous metal uncemented Regenerex RingLoc cup (Biomet, Warsaw, Il, USA)
• Components for the acetabulum (Lubinus cross linked cup)
cemented Lubinus cross linked cup (Waldemar Link, Hamburg, Germany).
• Arthroplasty components are for the femur (Cemented Lubinus SP II stem)
Cemented Lubinus SP II stem (Waldemar Link, Hamburg, Germany) with a ceramic 32 mm head.
• Arthroplasty components are for the femur (Corail stem)
Uncemented HA-coated Corail stem with a ceramic 32 mm head (DePuy, Johnsson & Johnsson, USA).

Locations

Country	Name	City	State
Sweden	Centre for research and development Uppsala university/County council of Gävleborg	Gävle

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	There are two study groups for femur: cemented and uncemented femur prosthetic components. There are also a femur reference group.	6 weeks after surgery	No
Primary	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	There are two study groups for acetabulum: cemented and uncemented acetabular prosthetic components. There are also an acetabular reference group.	6 weeks after surgery	No
Secondary	FEMUR:to analyze difference in SUV for each individual ROI inbetween the cemented and uncemented femur group		6 weeks and 6 months	No
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.		6 weks and 6 months	No
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.		preoperatively, 6 weeks and 6 months	No
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		6 months	No
Secondary	FEMUR:to analyze difference in SUV for the 4 upper ROI's analyzed together between each study group and the reference group		6 months	No
Secondary	ACETABULUM: to analyze difference in SUV for each individual ROI between the 2 study groups		6 weeks and 6 months	No
Secondary	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.		6 weeks and 6 months	No
Secondary	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.		preoperatively, 6 weeks and 6 months	No
Secondary	ACETABULUM: to analyze difference in SUV of all 9 ROI`s analyzed together between the cemented and uncemented acetabular study groups		6 months	No
Secondary	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		6 months	No