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

Arthroplasty Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03900039
• Other study ID #: #04-025
• Status: Completed
• Phase: N/A
• Start date: July 26, 2005
• Est. completion date: March 26, 2019

Study information

• Verified date: April 2019
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 26, 2019
• Est. primary completion date: July 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty Complications
• Hip Arthritis

Intervention

Device:
• Highly Cross Linked Polyethylene and oxidized zirconium femoral head
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

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

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 Feb 5. pii: S0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Survivorship of implant combinations	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	over 10 years