Acetabular Bone Vascularity in Metal-on-Metal Revisions

The purpose of this study is to determine if avascular necrosis of the acetabulum is present in metal-on-metal revisions and to what depth this dead avascular bone occurs.

A convenient sample of a consecutive series of 15 patients treated for metal on metal acetabular revision surgery will be included.

Study Overview

• Status: Terminated
• Conditions: Failure of Total Hip

Detailed Description

Patients being treated for metal on metal acetabular revision surgery by a physician at OrthoCarolina, PA will be screened for eligibility. These patients will be approached by their surgeon and asked to volunteer their participation in the study. Potential subjects will meet with a research coordinator to discuss details of the study and those you volunteer participation will be asked to sign an informed consent prior to the collection of study data. . Basic demographic information (initials, age, gender, height, weight, BMI), dates of original index surgery, reason for revision, type of implant being removed, and standard of care cobalt and chromium metal ion levels will be collected via chart review.

Patients who meet all eligibility criteria will have three biopsies performed at the time of their revision surgery. A pathologist will note the presence or absence of bone necrosis and will measure the length (mm) of necrosis, acute inflammation, chronic inflammation, normal bone, and entire bone specimen in order to obtain a ratio.

Biopsy Protocol:

A bone biopsy is a procedure in which bone samples are removed (with a special instrument during surgery) and looked at under a microscope for necrosis (tissue death), infection, or other bone disorders. Once the acetabular hip replacement implants have been removed the following steps will occur:

• The biopsy needle will be inserted into the bone (3 locations; 2 from ilium, 1 from pubis or ischium = 3 total).
• The biopsy needle will be withdrawn and firm pressure will be applied to the biopsy site for a few minutes, until the bleeding has stopped.
• Each bone biopsy sample will be labeled sequentially and by anatomic location (i.e., ilium #1, ilium #2)
• The normal bone will be marked on the bone sample.
• The bone biopsy sample will be sent to the lab for examination.
• The acetabulum bone will be reamed so the new implant can be seated.

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A convenience sample of a total of 15 patients will be enrolled at OrthoCarolina.

Description

Inclusion Criteria:

• Patients being revised for an aseptic metal on metal acetabular revision.
• Patient is greater than one year postoperative.
• Patient has had cobalt and chromium metal ion levels tested within 6 months of the planned revision surgery.
• Understands the local language and is willing and able to follow the requirements of the protocol.
• Understands the informed consent and signs the institutional review board or independent ethics committee (IRB/IEC) approved informed consent form.

Exclusion Criteria:

• History of infection
• Evidence of current substance or alcohol abuse
• Being treated with radiation, chemotherapy, immunosupression, or chronic steroid therapy (prednisone use up to 5 mg/qd or its equivalent is allowed)
• Is a prisoner

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Metal-on-Metal Revision; Patients who have a failed metal on metal total hip implant and are presenting for revision surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The depth (mm) of avascular bone from the acetabular surface per each patient	A bone biopsy is a procedure in which bone samples are removed (with a special instrument during surgery) and looked at under a microscope for necrosis (tissue death), infection, or other bone disorders. Once the acetabular hip replacement implants have been removed the following steps will occur: The biopsy needle will be inserted into the bone (3 locations; 2 from ilium, 1 from pubis or ischium = 3 total).; The biopsy needle will be withdrawn and firm pressure will be applied to the biopsy site for a few minutes, until the bleeding has stopped.; Each bone biopsy sample will be labeled sequentially and by anatomic location (i.e., ilium #1, ilium #2); The normal bone will be marked on the bone sample.; The bone biopsy sample will be sent to the lab for examination.	participants will be followed for the duration of their surgery, an expected average of 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ratio of necrotic bone per each patient	The ratio of each bone type (necrotic, acute inflammation, chronic inflammation, and normal bone) in relation to the length of the entire bone specimen will be measured.	paricipants will be followed for the duration of their surgery, an expected average of 2 hours

Collaborators and Investigators

• Sponsor: OrthoCarolina Research Institute, Inc.
• Collaborators: Presbyterian Pathology Group
• Investigators: Principal Investigator: Thomas Fehring, MD, OrthoCarolina Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: September 10, 2014
• First Submitted That Met QC Criteria: September 10, 2014
• First Posted (Estimate): September 12, 2014

Study Record Updates

• Last Update Posted (Estimate): July 22, 2016
• Last Update Submitted That Met QC Criteria: July 21, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: metal on metal total hip; avasuclar necrosis; acetabular revision; bone vascularity
• Other Study ID Numbers: HK025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No