THA Kinematics and Sound for Subjects for Normal, Diseased and Implanted Hips

November 13, 2019 updated by: Richard Komistek, The University of Tennessee, Knoxville

In Vivo Determination of Total Hip Arthroplasty (THA) Kinematics and Sound for Subjects for Normal, Diseased and Implanted Hips

The objective of this study is to analyze subjects having a normal hip and compare the in vivo kinematics to subjects requiring a total hip arthroplasty (THA) due to having a diseased hip and then later post-operative to their implanted hip. Ten subjects will have a normal hip, ten hips will be diseased, requiring a THA and then those ten diseased hips will be re-analyzed at least six months post-operatively after implantation of a THA.

Study Overview

Status

Status

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

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.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

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
    • Georgia
      • Cumming, Georgia, United States, 30041
        • Northside Hospital- Forsyth , GA 30041
    • Tennessee
      • Knoxville, Tennessee, United States, 37996
        • The University of Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Abercrombie Radiology

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

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with a diseased hip that requires THA. OR Subjects with a normal hip.

Description

Inclusion Criteria for diseased/implanted subjects:

  • Subjects will require a THA and will be implanted with either Summit/Pinnacle THA or Corail/Pinnacle THA.
  • Patients must be at least six months post-operative with no other surgical procedures conducted within the past six months that will prohibit them from performing the study activities.
  • Patients must be between 40-85 years of age.
  • Potential subjects will have a body weight of less than 250 lbs.
  • Participants must have Body Mass Index (BMI) of less than 38.
  • Potential subjects' THAs should be judged clinically successful with a HHS >90.
  • Subjects must have demonstrated no evidence of post-operative hip subluxation or dislocation.
  • Subjects must not walk with a detectable limp and must be able to actively abduct their operated hip against gravity without difficulty.
  • Participants must be able to walk on level ground, ascend and descend a ramp and rise from a chair without assistance.
  • Patients from the physician's list who do not meet the study requirements will not be considered.
  • Patients must be willing to sign the Informed Consent (IC)/HIPAA form to participate in the study.

Exclusion Criteria for diseased/implanted subjects:

  • Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
  • Subjects without one of the two types of required hip implants.
  • Subjects who have had surgery within the past 6 months that would prohibit them from performing level walking, ascend and descend a ramp and rise from a chair without aid or support of any kind.
  • Subjects who are unable to perform level walking, ascend and descend a ramp and rise from a chair without aid or support.
  • Subjects with pain, functional deficits, or generalized inflammatory.
  • Subjects who walk with a detectable limp.
  • Subjects who cannot actively abduct their operated hip against gravity without difficulty.
  • Subjects who are unwilling to sign IC/HIPAA document.
  • Subjects who have a HHS <90.

Inclusion Criteria for normal subjects:

  • Patients must not have any kind of hip implant.
  • Subjects must not have had any type of hip surgery or any pathological hip conditions, including osteoarthritis, or hip pain.
  • Patients must be between the ages of 18 and 65.
  • Potential subjects will have a body weight of less than 250 lbs.
  • Participants must have BMI of less than 38.
  • Pregnant or potentially pregnant females will be excluded from the study. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study.
  • Participants must be able to walk on level ground, ascend and descend a ramp and rise from a chair without aid of any kind or have had any kind of surgical procedure within the past 6 months that would affect his/her ability to perform the study activities.
  • Patients must be willing to sign the IC and HIPAA forms to participate in the study.
  • Patients must be between 160cm (5'3) and 193cm (6'4) tall

Exclusion Criteria for normal subjects:

  • Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study
  • Subjects with any kind of hip implant.
  • Subjects who have had any past hip surgery, have pathological hip conditions and/or hip pain.
  • Subjects who have had surgery within the past 6 months that would prohibit them from performing level walking, ascend and descend a ramp and rise from a chair without aid or support of any kind.
  • Subjects who are unable to perform level walking, ascend and descend a ramp and rise from a chair without aid or support.
  • Subjects who are unwilling to sign IC/HIPAA document.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Diseased Hip
Subjects will have a diseased hip which requires replacement, which will be implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA.
Radiation: Computer tomography
Computer tomography (CT) scan of the hip for creation of bone models.
Radiation: Fluoroscopy surveillance
Fluoroscopy evaluation of the hip during gait (level walking), chair rise, and ramp ascent and descent activities. Sound/vibration data will be collected simultaneously via non-invasive sensors attached to the hip joint.
Normal Hip
Subjects will have a normal hip.
Radiation: Computer tomography
Computer tomography (CT) scan of the hip for creation of bone models.
Radiation: Fluoroscopy surveillance
Fluoroscopy evaluation of the hip during gait (level walking), chair rise, and ramp ascent and descent activities. Sound/vibration data will be collected simultaneously via non-invasive sensors attached to the hip joint.
Implanted Group
All subjects from the Diseased Hip group were implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA
Radiation: Fluoroscopy surveillance
Fluoroscopy evaluation of the hip during gait (level walking), chair rise, and ramp ascent and descent activities. Sound/vibration data will be collected simultaneously via non-invasive sensors attached to the hip joint.
Device: DePuy Synthes total hip arthroplasty
Other Names:
  • DePuy Synthes Summit/Pinnacle THA
  • DePuy Synthes Corail/Pinnacle THA

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
Magnitude of Hip Separation During Primary Heel Strike
Time Frame: Approximately 2 years postoperatively.
Negative values indicate hip compression, position values indicate hip separation. All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.
Approximately 2 years postoperatively.
Magnitude of Hip Separation During Contra-lateral Toe Off
Time Frame: Approximately 2 years postoperatively.
Negative values indicate hip compression, position values indicate hip separation. All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.
Approximately 2 years postoperatively.
Magnitude of Hip Separation During Contra-lateral Heel Strike
Time Frame: Approximately 2 years postoperatively.
Negative values indicate hip compression, position values indicate hip separation. All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.
Approximately 2 years postoperatively.
Magnitude of Hip Separation During Primary Toe Off
Time Frame: Approximately 2 years postoperatively.
Negative values indicate hip compression, position values indicate hip separation. All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group.
Approximately 2 years postoperatively.

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.
The University of Tennessee, Knoxville

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
DePuy Synthes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard Komistek, Ph. D., The University of Tennessee

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.
April 1, 2016

Primary Completion (Actual)

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.
December 1, 2018

Study Completion (Actual)

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.
March 1, 2019

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).
November 20, 2015

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.
February 12, 2016

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.
February 15, 2016

Study Record Updates

Last Update Posted (Actual)

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 25, 2019

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 13, 2019

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, 2019

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.
  • 2631FB
  • IIS-14002 (Other Grant/Funding Number: DePuy Synthes)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Researchers would like to retain this study data in our secure database so as to continue to add relevant, current data to our digital collection to help us work with manufacturers in the future to create better implants that last longer and will not require revision surgery. Participants will be asked if their study data may remain a part of the University of Tennessee's Center for Musculoskeletal Research data collection for use in future studies in the IC. Identifiers are automatically removed from the database upon entry into the secure server. Data shared with sponsors is de-identified.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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