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

Sponsor

Hvidovre University Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT04585022

Collaborator

(none)

Enrollment

Arms

122.3

Actual Duration (Months)

Study Details

Study Description

Brief Summary

The investigators aimed to investigate the possible differences in metal ion concentrations in patients following one of two types of metal-on-metal articulating hip prosthesis regarding chromium and cobalt concentration, radiological findings, patient reported outcome measures and rate of revision at 5-years follow up.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Hip	Device: Magnum, Zimmer Biomet, Warsaw, IN Device: Recap, Zimmer Biomet, Warsaw, IN	N/A

Detailed Description

The metal-on-metal large-diameter-head (MoM-LDH) hip replacements increased in popularity during the start of the 21st century. Subsequently reports raised concerns regarding adverse reactions due to elevated chromium (Cr) and cobalt (Co) concentrations as well as high rates of other complications and revisions.

This was a single center parallel-group randomized controlled trial. The primary outcome was to compare Cr and Co concentrations at 5-years follow up following MoM-LDH total hip arthroplasty (MoM-LDH-THA) or MoM-LDH hip resurfacing (MoM-LDH-HR).

Secondary outcomes were radiological findings, patient reported outcome measures and revision rate at 5-years follow up.

The study was prematurely terminated in 2012 due to alerts and safety communications from the Danish national regulatory agency regarding early failure rates and high incidence of ARMD in patients with MoM hip implants [13]. At that time the study population consisted of 75 patients out of 200 planned for inclusion.

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

Both the care provider and patient were blinded until day of surgery. The laboratory analyzing blood metal concentrations were blinded to treatment allocation throughout the study.

Primary Purpose:

Treatment

Official Title:

Whole Blood Metal Ion Concentrations in Metal-on-metal Total Hip Arthroplasty and Hip Resurfacing - A Randomized Controlled Trial With 5-years Follow up Including 75 Patients

Actual Study Start Date :

Nov 1, 2006

Actual Primary Completion Date :

Jan 11, 2017

Actual Study Completion Date :

Jan 11, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Magnum A metal-on-metal large diameter head total hip arthroplasty	Device: Magnum, Zimmer Biomet, Warsaw, IN
Active Comparator: Recap A metal-on-metal hip resurfacing arthroplasty	Device: Recap, Zimmer Biomet, Warsaw, IN

Arm

Intervention/Treatment

Active Comparator: Magnum

A metal-on-metal large diameter head total hip arthroplasty

Device: Magnum, Zimmer Biomet, Warsaw, IN

Active Comparator: Recap

A metal-on-metal hip resurfacing arthroplasty

Device: Recap, Zimmer Biomet, Warsaw, IN

Outcome Measures

Primary Outcome Measures

Metal ion concentrations in blood [at 5 years follow up]
Chromium and cobalt concentrations in whole blood

Secondary Outcome Measures

Patient reported outcome measure 1 [at 5 years follow up]
Harris Hip Score (0-100, higher values meaning better outcome)
Patient reported outcome measure 2 [at 5 years follow up]
SF-36 (0-100, higher values meaning better outcome)
Implant survival [at 5 years follow up]
Rate of revision

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Primary or secondary hip osteoarthritis eligible for hip replacement surgery
Able to give informed consent
Able to complete follow up consultations

Exclusion Criteria:

Earlier or present infection of the hip
Severe systemic or metabolic disease leading to weakening of the bone
Severe congenital hip dysplasia
Osteoporosis and/or renal disease

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hvidovre University Hospital

Investigators

Principal Investigator: Anders Troelsen, MD, Hvidovre University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anders Troelsen, MD, PhD, dr.med., Professor, Hvidovre University Hospital

ClinicalTrials.gov Identifier:

NCT04585022

Other Study ID Numbers:

KF 01-309171

First Posted:

Oct 14, 2020

Last Update Posted:

Oct 29, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Anders Troelsen, MD, PhD, dr.med., Professor, Hvidovre University Hospital

Metal ion concentration

Total hip arthroplasty

Hip resurfacing

Additional relevant MeSH terms:

Osteoarthritis, Hip

Cimetidine

Study Results

No Results Posted as of Oct 29, 2020