Bone Metabolism Adjacent to Hip Prosthetic Surfaces. A Clinical F-PET/CT Study - Clinical Trial for Hip Osteo Arthritis | NCT02320682

Back to results

Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Surgery for Total Hip Arthroplasty (THA)

About this trial

This is an interventional treatment trial for Hip Osteo Arthritis

Eligibility Criteria

50 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Orthopaedic department Gävle hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Exeter femur component and Delta TT acetabular component

SP-CL femur component and Delta TT acetabular component

SP-CL femoral component and Delta PF acetabular component

Exeter femoral component and Delta PF acetabular component

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

FEMUR:to analyze difference in SUV for each individual ROI inbetween the cemented and uncemented femur group

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.

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.

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

FEMUR:to analyze difference in SUV for the 4 upper ROI's analyzed together between each study group and the reference group

ACETABULUM: to analyze difference in SUV for each individual ROI between the 2 study groups

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.

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.

ACETABULUM: to analyze difference in SUV of all 9 ROI's analyzed together between the two acetabular study groups

ACETABULUM: to analyze SUV of all 9 ROI's analyzed together between each acetabulum study group and the reference group

Full Information

NCT ID

NCT02320682

First Posted

December 15, 2014

Last Updated

May 15, 2018

Sponsor

gosta ullmark

1. Study Identification

Unique Protocol Identification Number

NCT02320682

Brief Title

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

Acronym

Fp-III

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Unknown status

Study Start Date

December 2014 (undefined)

Primary Completion Date

October 2020 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

gosta ullmark

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Osteo Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Exeter femur component and Delta TT acetabular component

Arm Type

Active Comparator

Arm Title

SP-CL femur component and Delta TT acetabular component

Arm Type

Active Comparator

Arm Title

SP-CL femoral component and Delta PF acetabular component

Arm Type

Active Comparator

Arm Title

Exeter femoral component and Delta PF acetabular component

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Surgery for Total Hip Arthroplasty (THA)

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

There are two study groups for femur: cemented and uncemented femur prosthetic components. There is also a femur reference group.

Time Frame

1 months after surgery

Title

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

Description

There are two study groups for acetabulum: two models of uncemented acetabular prosthetic components. There is also an acetabular reference group.

Time Frame

1 months after surgery

Secondary Outcome Measure Information:

Title

FEMUR:to analyze difference in SUV for each individual ROI inbetween the cemented and uncemented femur group

Time Frame

1, 4 and 9 months aftyer surgery

Title

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.

Time Frame

1, 4 and 9 months aftyer surgery

Title

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.

Time Frame

1, 4 and 9 months aftyer surgery

Title

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

Time Frame

4 and 9 months aftyer surgery

Title

FEMUR:to analyze difference in SUV for the 4 upper ROI's analyzed together between each study group and the reference group

Time Frame

4 and 9 months aftyer surgery

Title

ACETABULUM: to analyze difference in SUV for each individual ROI between the 2 study groups

Time Frame

1, 4 and 9 months aftyer surgery

Title

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.

Time Frame

1, 4 and 9 months aftyer surgery

Title

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.

Time Frame

1, 4 and 9 months aftyer surgery

Title

ACETABULUM: to analyze difference in SUV of all 9 ROI's analyzed together between the two acetabular study groups

Time Frame

4 and 9 months aftyer surgery

Title

ACETABULUM: to analyze SUV of all 9 ROI's analyzed together between each acetabulum study group and the reference group

Time Frame

4 and 9 months

Other Pre-specified Outcome Measures:

Title

To analyze radiographic difference for each of the four study groups between direct postoperativ and 9 months postoperative radiographs.

Time Frame

Direct postoperative (1-3 days) and 9 months

Title

To analyze clinical score for the four study groups

Description

Merle d Merle d´Aubignè and Postel score

Time Frame

preoperatively and 9 months postoperatively.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gösta Ullmark, MD

Organizational Affiliation

Orthopaedic department Gävle hospital, Gävle, Sweden and Centre for Research & Development Uppsala University/County Council of Gävleborg.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Orthopaedic department Gävle hospital

City

Gävle,

ZIP/Postal Code

80187

Country

Sweden

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

Hip Osteo Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial