NCT02321683

Brief Summary

The purpose of this trial is to evaluate a new method of applying hydroxyapatite coatings on cement-less femoral stems.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_4

Status
completed

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

December 1, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed
Last Updated

December 22, 2014

Status Verified

December 1, 2014

Enrollment Period

1.5 years

First QC Date

December 17, 2014

Last Update Submit

December 17, 2014

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • Early and intermediate periprosthetic bone remodeling

    Bone densitometry measured by DXA

    5 years

  • Early and intermediate femoral stem stability

    Radiostereometric analysis of femoral stem movements relative to bone

    5 years

Secondary Outcomes (2)

  • Clinical function

    5 years

  • Radiographic signs of loosening

    5 years

Study Arms (2)

Bonemaster

EXPERIMENTAL

Cement-less femoral stems with electrochemical deposition of hydroxyapatite

Device: Taperloc

Hydroxyapatite

ACTIVE COMPARATOR

Cement-less femoral stems with plasmasprayed hydroxyapatite

Device: Taperloc

Interventions

TaperlocDEVICE

Femoral stem with electrochemical deposition of hydroxyapatite

BonemasterHydroxyapatite

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • non-inflammatory hip arthritis, life expectancy of at least 10 years and hip anatomy allowing the use of standard implants

You may not qualify if:

  • infection, revision surgery, severe morbidity and obvious bone loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Flatoy B, Rohrl SM, Boe B, Nordsletten L. No medium-term advantage of electrochemical deposition of hydroxyapatite in cementless femoral stems. 5-year RSA and DXA results from a randomized controlled trial. Acta Orthop. 2016 Feb;87(1):42-7. doi: 10.3109/17453674.2015.1084768. Epub 2015 Sep 12.

    PMID: 26364953DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Lars Nordsletten

Study Record Dates

First Submitted

December 17, 2014

First Posted

December 22, 2014

Study Start

December 1, 2003

Primary Completion

June 1, 2005

Study Completion

December 1, 2008

Last Updated

December 22, 2014

Record last verified: 2014-12