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Completed

NCT Number: NCT03900039

An Assessment of 4 Different Bearing Types in Hip Replacement Types to Analsye the Lowest Wear Rates of Polyethylene

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.

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Key information

Conditions

Arthroplasty Complications Hip Arthritis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

About this study

In hip replacements, arguably the most important thing for survivorship is what rubs against what.

Traditionally surgeons used metal (Cobalt-Chrome) against a conventional polyethylene (plastic). More recently (around 15 years ago) a newer more dense type of polyethylene (called XLPE) had been developed and a new type of head called Oxidized Zirconium was also developed.

In this trial, adults who were undergoing hip replacements were randomized assigned into one of the four groups:

Group 1: old plastic vs metal head Group 2: Old plastic against Oxidized Zirconium Group 3: New plastic versus metal head Group 4 New plastic vs Oxidized Zirconium

All patients were followed up for a minimum of 10 years to assess which group wore the most amount of polyethylene and which group had the best survival rate.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Highly Cross Linked Polyethylene and oxidized zirconium femoral head

Device

Differing bearing surfaces:

  • Conventional polyethylene versus cobalt Chrome heads
  • Conventional polyethylene versus Oxidized Zirconium heads
  • Highly Cross-linked polyethylene versus Cobalt Chrome heads
  • Highly Cross-linked polyethylene versus Oxidized Zirconium heads

Other names: Varilast - from Smith & Nephew

Primary outcomes

  1. Wear rates of polyethylene over 10 years

    Time frame: Over 10 years of wear rates

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

Secondary outcomes

  1. Survivorship of implant combinations

    Time frame: over 10 years

    Assess linear and volumetric wear to assess if those bearing surfaces require to be revised (exchanged) during the experimental period in one group more than the others

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

Randomized Control Trial of Four Bearing Surfaces in Primary Total Hip Arthroplasty in Patients Over the Age of 18 Years

Important dates

Study start
2005
Primary completion
2018
Study completion
2019
First posted
Apr 2, 2019
Registry last updated
Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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