NCT03900039

Brief Summary

The aim of the study is to assess the ideal bearing surfaces in hip replacement by comparing 4 different combinations. In a hip replacement this means what the head and the socket liner are made of.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

July 26, 2005

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
Last Updated

April 2, 2019

Status Verified

April 1, 2019

Enrollment Period

13 years

First QC Date

March 28, 2019

Last Update Submit

April 1, 2019

Conditions

Arthroplasty ComplicationsHip Arthritis

Keywords

Hip arthroplastyTribologywear

Outcome Measures

Primary Outcomes (1)

  • Wear rates of polyethylene over 10 years

    Linear and volumetric wear were measured in the most recent radiographs using a computer software package (Polyware Rev. 5; Draftware).

    Over 10 years of wear rates

Secondary Outcomes (1)

  • Survivorship of implant combinations

    over 10 years

Study Arms (4)

Conventional Polyethylene versus metal head

ACTIVE COMPARATOR

This is the more conventional group bearing surfaces

Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral head

Conventional Polyethylene versus oxidized zirconium head

EXPERIMENTAL

This group uses the more conventional polyethylene against the newer head

Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral head

Newer Cross linked Polyethylene metal head

EXPERIMENTAL

In this group we continued with the conventional polyethylene, but added in the new type of head (oxidized zirconium)

Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral head

Newer Cross linked Polyethylene versus oxidized zirconium head

EXPERIMENTAL

In this group, we added both the new head and the new polyethylene

Device: Highly Cross Linked Polyethylene and oxidized zirconium femoral head

Interventions

Highly Cross Linked Polyethylene and oxidized zirconium femoral headDEVICE

Differing bearing surfaces: 1. Conventional polyethylene versus cobalt Chrome heads 2. Conventional polyethylene versus Oxidized Zirconium heads 3. Highly Cross-linked polyethylene versus Cobalt Chrome heads 4. Highly Cross-linked polyethylene versus Oxidized Zirconium heads

Also known as: Varilast - from Smith & Nephew
Conventional Polyethylene versus metal headConventional Polyethylene versus oxidized zirconium headNewer Cross linked Polyethylene metal headNewer Cross linked Polyethylene versus oxidized zirconium head

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adults with no history of cancer, infection of the hip and with the capacity to make informed consent for the trial

You may not qualify if:

  • those under the age of 18 and over 65. Those with a history of cancer and infection. Those without the capacity to make an informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (2)

  • Atrey A, Ward SE, Khoshbin A, Hussain N, Bogoch E, Schemitsch EH, Waddell JP. Ten-year follow-up study of three alternative bearing surfaces used in total hip arthroplasty in young patients: a prospective randomised controlled trial. Bone Joint J. 2017 Dec;99-B(12):1590-1595. doi: 10.1302/0301-620X.99B12.BJJ-2017-0353.R1.

    PMID: 29212681BACKGROUND

  • Rames RD, Stambough JB, Pashos GE, Maloney WJ, Martell JM, Clohisy JC. Fifteen-Year Results of Total Hip Arthroplasty With Cobalt-Chromium Femoral Heads on Highly Cross-Linked Polyethylene in Patients 50 Years and Less. J Arthroplasty. 2019 Jun;34(6):1143-1149. doi: 10.1016/j.arth.2019.01.071. Epub 2019 Feb 5.

    PMID: 30808529RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessment of the implants was done by a secondary center that was unaware of which the bearing type was in which patient.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2019

First Posted

April 2, 2019

Study Start

July 26, 2005

Primary Completion

July 26, 2018

Study Completion

March 26, 2019

Last Updated

April 2, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)