NCT01623687

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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 4, 2014

Status Verified

April 1, 2014

Enrollment Period

3.1 years

First QC Date

January 17, 2012

Last Update Submit

April 3, 2014

Conditions

Osteo Arthritis

Keywords

total hip arthroplastybone metabolismmineralisation

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (10)

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

    6 weeks and 6 months

  • 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

  • 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

  • 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

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

    6 months

  • +5 more secondary outcomes

Study Arms (4)

Regenerex

ACTIVE COMPARATOR
Device: Component for acetabulum (Regenerex RingLoc cup)

Lub cup

ACTIVE COMPARATOR
Device: Components for the acetabulum (Lubinus cross linked cup)

SP II

ACTIVE COMPARATOR
Device: Arthroplasty components are for the femur (Cemented Lubinus SP II stem)

Corail

ACTIVE COMPARATOR
Device: Arthroplasty components are for the femur (Corail stem)

Interventions

Component for acetabulum (Regenerex RingLoc cup)DEVICE

A fibrous metal uncemented Regenerex RingLoc cup (Biomet, Warsaw, Il, USA)

Also known as: Regenerex RingLoc cup
Regenerex
Components for the acetabulum (Lubinus cross linked cup)DEVICE

cemented Lubinus cross linked cup (Waldemar Link, Hamburg, Germany).

Also known as: Lubinus cross linked cup
Lub cup
Arthroplasty components are for the femur (Cemented Lubinus SP II stem)DEVICE

Cemented Lubinus SP II stem (Waldemar Link, Hamburg, Germany) with a ceramic 32 mm head.

Also known as: Cemented Lubinus SP II stem
SP II
Arthroplasty components are for the femur (Corail stem)DEVICE

Uncemented HA-coated Corail stem with a ceramic 32 mm head (DePuy, Johnsson \& Johnsson, USA).

Also known as: Uncemented HA-coated Corail stem with a ceramic 32 mm head
Corail

Eligibility Criteria

Age50 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients diagnosed to have unilateral hip osteo arthritis (Charnley group A) aimed for THA at the orthopedic clinic Gävle hospital.

You may not qualify if:

  • Systemic disease or medication affecting the skeleton

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for research and development Uppsala university/County council of Gävleborg

Gävle, 80187, Sweden

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32686502DERIVED

  • 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.

    PMID: 30520317DERIVED

Study Officials

  • Gösta Ullmark

    Ass Professor

    STUDY CHAIR

Central Study Contacts

Gösta Ullmark, MD, PhD

CONTACT

+46706466149gosta.ullmark@lg.se

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2012

First Posted

June 20, 2012

Study Start

August 1, 2011

Primary Completion

September 1, 2014

Study Completion

March 1, 2015

Last Updated

April 4, 2014

Record last verified: 2014-04

Locations

SE(1)