Trial Outcomes & Findings for Metal Ions in Ceramic on Metal Total Hip Arthroplasty (NCT NCT01437124)

Results Overview

Serum cobalt chromium levels post THR

Recruitment status

COMPLETED

Target enrollment

83 participants

Primary outcome timeframe

2 years post THR

Results posted on

2016-06-06

Participant milestones
Measure	Ceramic on Metal THA Those who have received a ceramic on metal total hip replacement
Overall Study STARTED	83
Overall Study COMPLETED	83
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Metal Ions in Ceramic on Metal Total Hip Arthroplasty

Baseline characteristics by cohort
Measure	Ceramic on Metal THA n=83 Participants Those who have received a ceramic on metal total hip replacement
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	73 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Region of Enrollment United Kingdom	83 participants n=5 Participants

Timeframe: 2 years post THR

Population: metal ion levels

Serum cobalt chromium levels post THR

Outcome measures
Measure	Ceramic on Metal THA n=83 Participants Those who have received a ceramic on metal total hip replacement
Cobalt Chromium Levels	1.06 micrograms/dl Interval 0.05 to 7.22

Timeframe: 2 years post THR

Population: 24 colour FISH

Deviation of karyotype from normal 2 years post THR

Outcome measures
Measure	Ceramic on Metal THA n=83 Participants Those who have received a ceramic on metal total hip replacement
Chromosomal Abnormality	0.11 % chromosomal abberations Interval 0.0 to 0.25

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Wirral NHS Trust

Phone: 0151 678 6111