A Study Comparing Ceramic-on-metal Articulation to Metal-on-metal Articulation in Cementless Primary Hip Arthroplasty

Osteoarthritis Clinical Trial

Official title:

A Multi-center Prospective Randomized Control Trial to Compare Two Articulating Bearing Surfaces, Ceramic-on-metal and Metal-on-metal as Used in Cementless Primary Hip Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00754520
• Other study ID #: BMETEU.CR.EU11
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2009
• Est. completion date: March 2022

Study information

• Verified date: February 2022
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup.

Description:

The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup in regards to the composite clinical success (CCS) rate, as defined in the protocol, at 2 year postoperative.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 211
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients presenting with osteoarthritis and suitable for primary Total Hip Replacement

• Patients preoperative Harris Hip Score <= 70 points

• Patients aged over 18 and under 75

• Patients with limited co-morbidity - ASA I-III

• Patients with normal urea and electrolyte levels and creatinine levels

• Patients must be able to understand instructions and be willing to return for follow-up

• Patients willing to provide blood and urine samples for metal ion analysis at follow up

Exclusion Criteria:

• Patients preoperative Harris Hip Score > 70 points

• Previous prosthetic hip surgery

• Patients with significant co-morbidity - ASA IV - V

• Dementia and inability to understand and follow instructions

• Neurological conditions affecting movement

• Existing metal implant or fixation device

• Pregnancy

• Presence of symptomatic arthritis in other lower limb joints

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• Ceramic On Metal
Ceramic on Metal articulation using M2a-38™ mm cup
• Metal on Metal
Metal on Metal articulation using M2a-38™ mm cup

Locations

Country	Name	City	State
Finland	Central Finland Central Hospital	Jyvaskyla
Finland	Kymenlaakso Central Hospital	Kotka
United Kingdom	North Hampshire Hospital	Basingstoke

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

Finland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Clinical Success (CCS) Rate as defined in the protocol		6 weeks, 6 months, annually up to 10 years
Secondary	Oxford Hip Score		6 weeks, 6 months, annually up to 10 years
Secondary	Womac Score		6 weeks, 6 months, annually up to 10 years
Secondary	Metal Ion concentrations in blood and urine		6 weeks, 6 months, annually up to 10 years
Secondary	Measurement of cellular markers in blood		6 weeks, 6 months, annually up to 10 years
Secondary	Complications		Any Time
Secondary	Survivorship		Any Time