Trial Outcomes & Findings for Whole Blood Metal Ion Concentrations in Metal-on-metal Total Hip Arthroplasty and Hip Resurfacing (NCT NCT04585022)

Results Overview

Chromium and cobalt concentrations in whole blood

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

75 participants

Primary outcome timeframe

at 5 years follow up

Results posted on

2023-03-03

Participant Flow

The study was conducted in a tertiary health care center in Copenhagen, Denmark from November 2006 to January 2012. 5-years follow up consultations were conducted from 2011 to 2017.

Participant milestones

Participant milestones
Measure	Magnum A metal-on-metal large diameter head total hip arthroplasty Magnum, Zimmer Biomet, Warsaw, IN	Recap A metal-on-metal hip resurfacing arthroplasty Recap, Zimmer Biomet, Warsaw, IN
Overall Study STARTED	39	36
Overall Study COMPLETED	33	25
Overall Study NOT COMPLETED	6	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Whole Blood Metal Ion Concentrations in Metal-on-metal Total Hip Arthroplasty and Hip Resurfacing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Magnum n=39 Participants A metal-on-metal large diameter head total hip arthroplasty Magnum, Zimmer Biomet, Warsaw, IN	Recap n=36 Participants A metal-on-metal hip resurfacing arthroplasty Recap, Zimmer Biomet, Warsaw, IN	Total n=75 Participants Total of all reporting groups
Age, Continuous	61.9 years n=5 Participants	59.4 years n=7 Participants	60.8 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	26 Participants n=7 Participants	52 Participants n=5 Participants
Region of Enrollment Denmark	39 Participants n=5 Participants	36 Participants n=7 Participants	75 Participants n=5 Participants
BMI	28.4 kg/m^2 n=5 Participants	27.45 kg/m^2 n=7 Participants	27.9 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: at 5 years follow up

Population: The discrepancy between numbers of patients analysed and the numbers presented in Participant flow is due to patients who had bilateral MoM hip replacement at the 5-year follow-up were excluded in addition to those lost to follow up, who had revision surgery or died before 5-years follow up.

Chromium and cobalt concentrations in whole blood

Outcome measures

Outcome measures
Measure	Magnum n=25 Participants A metal-on-metal large diameter head total hip arthroplasty Magnum, Zimmer Biomet, Warsaw, IN	Recap n=20 Participants A metal-on-metal hip resurfacing arthroplasty Recap, Zimmer Biomet, Warsaw, IN
Metal Ion Concentrations in Blood Chromium	1.36 micrograms/liter Interval 0.99 to 3.11	1.21 micrograms/liter Interval 0.88 to 3.03
Metal Ion Concentrations in Blood Cobalt	1.67 micrograms/liter Interval 0.86 to 2.31	0.92 micrograms/liter Interval 0.64 to 1.49

SECONDARY outcome

Timeframe: at 5 years follow up

Harris Hip Score (0-100, higher values meaning better outcome)

Outcome measures

Outcome measures
Measure	Magnum n=33 Participants A metal-on-metal large diameter head total hip arthroplasty Magnum, Zimmer Biomet, Warsaw, IN	Recap n=25 Participants A metal-on-metal hip resurfacing arthroplasty Recap, Zimmer Biomet, Warsaw, IN
Harris Hip Score	100 units on a scale Interval 98.0 to 100.0	100 units on a scale Interval 93.0 to 100.0

SECONDARY outcome

Timeframe: at 5 years follow up

Population: The total number of patients analyzed is different from the total number of patients who completed the study, since some patients had missing data for this questionnaire.

Short Form 36 Health Survey Questionnaire (SF-36) (0-100, higher values meaning better outcome)

Outcome measures

Outcome measures
Measure	Magnum n=30 Participants A metal-on-metal large diameter head total hip arthroplasty Magnum, Zimmer Biomet, Warsaw, IN	Recap n=26 Participants A metal-on-metal hip resurfacing arthroplasty Recap, Zimmer Biomet, Warsaw, IN
SF-36 Vitality	77.5 score on a scale Interval 60.0 to 85.0	75 score on a scale Interval 32.5 to 85.0
SF-36 Physical function	90 score on a scale Interval 68.75 to 95.0	90 score on a scale Interval 70.0 to 100.0
SF-36 Physical restriction	100 score on a scale Interval 66.67 to 100.0	100 score on a scale Interval 50.0 to 100.0
SF-36 Bodily pain	92 score on a scale Interval 62.0 to 100.0	84 score on a scale Interval 62.0 to 100.0
SF-36 General health	74.5 score on a scale Interval 61.75 to 89.25	79.5 score on a scale Interval 56.44 to 87.0
SF-36 Social function	100 score on a scale Interval 100.0 to 100.0	100 score on a scale Interval 100.0 to 100.0
SF-36 Emotional restriction	100 score on a scale Interval 100.0 to 100.0	100 score on a scale Interval 100.0 to 100.0
SF-36 Mental Health	92 score on a scale Interval 72.0 to 96.0	88 score on a scale Interval 76.0 to 92.0

SECONDARY outcome

Timeframe: at 5 years follow up

Rate of revision during the follow-up period, calculated as number of revisions (numerator) out of the total number of patients starting the study (denominator)

Outcome measures

Outcome measures
Measure	Magnum n=39 Participants A metal-on-metal large diameter head total hip arthroplasty Magnum, Zimmer Biomet, Warsaw, IN	Recap n=36 Participants A metal-on-metal hip resurfacing arthroplasty Recap, Zimmer Biomet, Warsaw, IN
Number of Patients Undergoing Revision	0 Participants	6 Participants

Adverse Events

Magnum

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Recap

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Magnum n=39 participants at risk A metal-on-metal large diameter head total hip arthroplasty Magnum, Zimmer Biomet, Warsaw, IN	Recap n=36 participants at risk A metal-on-metal hip resurfacing arthroplasty Recap, Zimmer Biomet, Warsaw, IN
Infections and infestations Septic loosening of stem	0.00% 0/39 • 5 years	2.8% 1/36 • Number of events 1 • 5 years
Injury, poisoning and procedural complications Fracture of femoral neck	0.00% 0/39 • 5 years	5.6% 2/36 • Number of events 2 • 5 years
Musculoskeletal and connective tissue disorders Unexplained hip pain without joint failure	0.00% 0/39 • 5 years	2.8% 1/36 • Number of events 1 • 5 years
Musculoskeletal and connective tissue disorders Aseptic loosening of cup	0.00% 0/39 • 5 years	2.8% 1/36 • Number of events 1 • 5 years
Product Issues adverse reaction to metal debris	0.00% 0/39 • 5 years	2.8% 1/36 • Number of events 1 • 5 years

Other adverse events

Adverse event data not reported

Additional Information

MD Peter Nyby Hersnaes

Copenhagen University Hospital Hvidovre, Orthopaedic Department

Phone: +45 40104845

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place