MITCHEx-11: An extension trial to assess long-term serum metal ions in patients recruited in the MITCH Metal Ions Study.

MITCHEx-11: An extension trial to assess long-term serum metal ions in patients recruited in the MITCH Metal Ions Study - A prospective consecutive series, assessing Chrome and Cobalt metal ions in patients after hip resurfacing surgery, clinical trial.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12611000819921

Acronym

MITCHEx-11

Enrollment

Registered

2011-08-04

Start date

2011-09-04

Completion date

2013-06-30

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

The aim of the study is to analyse the serum metal ions for the MITCH system throughout the steady state phase after surgery. This study extends the current MITCH Metal Ions Study from an endpoint of 2 years to a longer post-operative time point of 5 years. The results will be used as a direct comparison to other research completed for hip resurfacing components on the Australian Market. This study also forms part of the post-market surveillance activities of the Sponsor.

Interventions

This study is an extension study which recruits patients that formerly took place in the MITCH Metal Ions Study which followed patients for 2 years after their hip surgery by looking at blood metal ion concentrations, quality of life, hip functionality/pain. The ACTR Number for the MITCH Metal Ions Study is ACTRN12608000193370. This study took patients that required a total hip replacement, or just hip re-surfacing and used either the MITCH modular system or MITCH resurfacing system respectively. Both used 'metal-on-metal' components. The study aimed to analysed chrome and cobalt blood chemistry and compare the results to activity levels. The patients were followed at 6 weeks, 6 months, 12 months and 24 months post-operatively. At each visit the patient had a blood test, an X-ray and completed 3 x questionnaires relating to health, function of hip and quality of life. This extension study aims to continue following these patients at 3 and 5 years after their original surgery. This is an observational study which is both retrospective and prospective. The retrospective data will come from the aforementioned MITCH Metal Ions Study.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Patients who meet the success criteria for MITCH Metal Ions Study and are invited by Investigator to participate 2. Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up. 3. Patients who are capable of, and have signed the study specific, HREC-approved informed consent form Success criteria for patients to be eligible for MITCHEx-11 Study: 1. Patients who completed surgery with MITCH THR resurfacing or modular 2. Patients who completed follow-up at 6-month time point in MITCH Metal Ions Study 3. No protocol deviation or serious adverse event leading to termination from the MITCH Metal Ions study. 4. No voluntary withdrawal from the MITCH Metal Ions study.

Exclusion criteria

Patients who have had or require revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint 2. Patients who have had their MITCH TRH revised to a non-MITCH THR 3. Patients taking health supplements with Cr or Co. 4. Patients with metal implants other than the MITCH TRH 5. Patients who are immunologically suppressed or receiving steroids in excess of normal physiological requirements. 6. Patients with a cognitive impairment, an intellectual disability or a mental illness

Outcome results