Stability of Revision Total Hip Arthroplasty Implants Using Radiostereometric Analysis

November 4, 2013 updated by: Charles R. Bragdon, Massachusetts General Hospital

Analysis of the Stability of Total Hip Arthroplasty Implants Used in Revision Surgery Using Radiostereometric Analysis (RSA)

The specific aim is to quantify the stability of the acetabular and femoral components of a revision total hip arthroplasty (THA) in vivo as currently performed at our institution. In this way, the investigators will gain insight into the outcome of the current state of the art of revision arthroplasty surgery. In the past, acetabular and femoral component stability has been measured using radiostereometric analysis (RSA) and when patients having revision total hip operations were compared to patients undergoing primary total hip operations it was possible to determine differences in stability and this was predictive of the intermediate to long-term performance of the acetabular and femoral reconstruction. The investigators propose to use this established, high resolution technique to assess and compare the stability of the revision implants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female.
  2. 25 to 75 years of age.
  3. Subjects requiring revision total hip replacement.
  4. Subjects who demonstrate the ability to return to MGH for follow-up for the next five years.

Exclusion Criteria:

  1. Subjects with limited life span.
  2. Subjects with difficulty in comprehending study protocol for any reason.
  3. Subjects with complex disease entities which significantly increase the risks of the surgery such as any major platelet abnormality, hematological disorder, or any other major medical complication which could substantially reduce longevity, put them at further risk due to immunocompromisation or increase the risk of infection.

  4. Female subjects that are pregnant or who may suspect they are pregnant or who plan to become pregnant while participating in this study.

    • A urine HCG will be done in all women of child bearing potential prior to RSA imaging at each follow-up visit. The result will be recorded in the research record.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Revision Total Hip
patients recieving a revision total hip replacement will be assessed for implant stability and wear using RSA. Tantalum beads will be placed in the polyethylene and surrounding pelvic and femoral bone.
Procedure: Bead placement during revision hip replacement surgery
Tantalum beads will be placed in the surrounding pelvic and femoral bone and the polyethylene component during surgical treatment of failed primary THA components

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stability of Acetabular and femoral components
Time Frame: 1, 2, 3, 5 years after surgery
RSA films will be taken at the prescribed time intervals to measure component mothion over time.
1, 2, 3, 5 years after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Wear of the polyethlene component
Time Frame: 1, 2, 3, 5 years after surgery
The movement of the femoral head into the polyethylenen, (wear), will be measured at the prescribed time intervals.
1, 2, 3, 5 years after surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment/questionaire HOOS
Time Frame: Pre-op, 1, 2, 3, 5 years after surgery
Hip disability and Osteoarthritis Outcome Score
Pre-op, 1, 2, 3, 5 years after surgery
Assessment/Questionaires Harris Hip Score
Time Frame: Pre-op, 1, 2, 3, 5 years after surgery
Hip specific questionaire
Pre-op, 1, 2, 3, 5 years after surgery
Assessment/Questionaire UCLA Activity Score
Time Frame: Pre-op, 1, 2, 3, 5 years after surgery
Measure of activity level
Pre-op, 1, 2, 3, 5 years after surgery
Assessment/Questionaire EQ-5D
Time Frame: Pre-op, 1, 2, 3, 5 years after surgery
General health and cost effectiveness measure
Pre-op, 1, 2, 3, 5 years after surgery
Assessment/Questionaire Case Mix indicator
Time Frame: Pre-op, 1, 3, 5, 7, 10 years after surgery
Determines comorbidities
Pre-op, 1, 3, 5, 7, 10 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012P000925
  • 216494 (Other Grant/Funding Number: MGH Orhtopaedic Department Funds 216494)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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