Overview

Status:Not yet recruiting
Keywords:MOM Hip Implants , Total Hip Arthroplasty , Metal on Metal Hip Replacement , MRI , Metal Ion level , MOM vs. MOP
IRB Number:00057887
Specialty:Orthopaedic Surgery
Sub Specialty:

Brief Summary

I. Purpose and Objective

This study has been designed to estimate the prevalence of soft tissue changes following primary THA surgery in patients having received one of two Biomet implant types; a MOP primary THA or Biomet MOM primary THA devices (M2a Ringloc, M2a Taper, M2a 38 or the M2a Magnum) in 308-436 total patients at four centers.

The primary objective of the study is to estimate the prevalence of soft tissue changes in unbiased MoM and MoP samples. Secondary objectives are to determine if the presence of metal ion concentrations generally increases over time and if those concentrations are related to anticipated or unanticipated adverse events, adverse local tissue reactions (ALTRs) or revision. To establish a baseline level of metal ions in a relevant population, 100 THA patients (25 consecutive at each center) will have metal ion levels tested in whole blood and in serum.

Principle Investigator: Chris Pelt
Principle Department: Orthopedic Surgery
Co Investigator: Chris Pelt

Contact Information

Name:Michael Anderson
Phone:801-213-3442
Email:mike.anderson@hsc.utah.edu

Inclusion Criteria

Pre-operative patient group:

Patients must meet the following eligibility criteria:

1. Are scheduled to receive any primary total hip replacement device

2. The patient does not have a total hip replacement or total resurfacing hip in their contralateral side.

3. The patient is willing to undergo a preoperative blood draw and participate in the study.

4. The patient consents to participating in the study.

Post-operative patient group:

Patients who have received the indicated Biomet MoM replacements or Biomet MoP primary hip replacement devices will be contacted to request participation in the study:

Postoperative Group Inclusion criteria:

1. Patient meets the sampling plan requirements listed below (Table 1)

2. Patient's hip has not already been revised (revised patients should be approached for consent but will be considered screen failures; i.e., not count toward enrollment goal)

 

Table 1: Study enrollment distribution Current year

Years 1-5 (1/1/11 – 12/31/07)

Year 6

(1/1/06 – 12/31/06)

Year 7

(1/1/05 – 12/31/05)

Year 8

(1/1/04 – 12/31/04)

Year 9 (1/1/03 – 12/31/03)

Year 10 (1/1/02-12/31/02)

Total

Pre-operative group

Pre-THA

100

n/a

n/a

n/a

n/a

n/a

n/a

100

Post-operative group

Magnum

n/a

24 ea. year

24

n/a

n/a

n/a

n/a

144

MOP

n/a

n/a

25

25

25

25

n/a

100

M2a 38

n/a

n/a

8-24

8-24

8-24

n/a

n/a

24-72

Ringloc

n/a

n/a

n/a

n/a

8-24

8-24

8-24

24-72

M2a Taper

n/a

n/a

n/a

n/a

n/a

8-24

8-24

16-48

 

Exclusion Criteria

Patients in the preoperative group will be excluded for the following reasons:

1) If the patient has a total hip replacement or total resurfacing hip in their contralateral side.

2) If the patient refuses the blood draw or study participation

3) If the patient fails to consent to participating in the study

Postoperative Group Exclusion criteria:

1) If the patient is contraindicated for MRI(only for patients who have not been revised) 

2) If the patient fails to consent to participating in the study.

No other exclusion criteria apply.