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

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

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?

Study Overview

• Status: Unknown
• Conditions: Hip Osteo Arthritis
• Intervention / Treatment: Device: Surgery for Total Hip Arthroplasty (THA)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gävle,, Sweden, 80187
    • Orthopaedic department Gävle hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Exeter femur component and Delta TT acetabular component	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.
Active Comparator: SP-CL femur component and Delta TT acetabular component	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.
Active Comparator: SP-CL femoral component and Delta PF acetabular component	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.
Active Comparator: Exeter femoral component and Delta PF acetabular component	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Time Frame
FEMUR:to analyze difference in SUV for each individual ROI inbetween the cemented and uncemented femur group	1, 4 and 9 months aftyer surgery
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
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
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
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
ACETABULUM: to analyze difference in SUV for each individual ROI between the 2 study groups	1, 4 and 9 months aftyer surgery
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
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
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
ACETABULUM: to analyze SUV of all 9 ROI's analyzed together between each acetabulum study group and the reference group	4 and 9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
To analyze clinical score for the four study groups	Merle d Merle d´Aubignè and Postel score	preoperatively and 9 months postoperatively.

Collaborators and Investigators

• Sponsor: gosta ullmark
• Investigators: Principal Investigator: Gösta Ullmark, MD, Orthopaedic department Gävle hospital, Gävle, Sweden and Centre for Research & Development Uppsala University/County Council of Gävleborg.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 15, 2014
• First Submitted That Met QC Criteria: December 18, 2014
• First Posted (Estimate): December 19, 2014

Study Record Updates

• Last Update Posted (Actual): May 16, 2018
• Last Update Submitted That Met QC Criteria: May 15, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: Fingerprint III