Randomised Controlled Trial comparing Ceramic-on-Metal and Metal-on-Metal arthroplasty bearing surfaces - functional outcomes and serum metal ion levels following total hip arthroplasty

An evaluation of ceramic-on-metal versus metal-on-metal bearing surface on functional scores, serum metal ion levels and radiological parameters in patients receiving total hip arthoplasty

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000423213

Acronym

COMBAT trial

Enrollment

Registered

2009-06-10

Start date

2009-04-01

Completion date

2010-08-02

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This randomised controlled study of 80 patients receiving total hip joint replacements aims to compare the post operative serum metal ion levels, functional outcomes and radiological parameters of ceramic-on-metal and metal-on-metal bearing surfaces. All patients will receive the same acetabular component (Pinnacle) and femoral stem (Corail) with only the femoral head component been randomised to either a biolox cermic head of ultamet metal head. Results at 6,12,24 and 60 months will be compared.

Interventions

Both arms of the study involve total hip joint replacement - performed with cementless implants (Pinnacle acetabular shell with Ultramet metal insert with a Corail cementless femoral stem). The patient will then be randomised to receive either a ceramic (biolox) or metal (ultamet) femoral head. Operation time is estimated at 60 minutes.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 No limit to 100 No limit

Healthy volunteers

Inclusion criteria

Patients clinically suitable for a 'hard-on hard' total hip replacement bearing surface Primary total hip arthroplasty

Exclusion criteria

Contra-lateral hip arthroplasty with a metal-on-metal bearing surface. Chronic Renal Failure

Outcome results