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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02682602
Recruitment Status : Completed
First Posted : February 15, 2016
Results First Posted : November 8, 2019
Last Update Posted : November 25, 2019
Sponsor:
Collaborator:
DePuy Synthes
Information provided by (Responsible Party):
Richard Komistek, The University of Tennessee, Knoxville

Brief Summary:
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.

Condition or disease Intervention/treatment
Hip Injuries Device: DePuy Synthes total hip arthroplasty Radiation: Computer tomography Radiation: Fluoroscopy surveillance

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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: In Vivo Determination of Total Hip Arthroplasty (THA) Kinematics and Sound for Subjects for Normal, Diseased and Implanted Hips
Study Start Date : April 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Device: DePuy Synthes total hip arthroplasty
Other Names:
  • DePuy Synthes Summit/Pinnacle THA
  • DePuy Synthes 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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with a diseased hip that requires THA. OR Subjects with a normal hip.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682602


Locations
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United States, Georgia
Northside Hospital- Forsyth , GA 30041
Cumming, Georgia, United States, 30041
United States, Tennessee
Abercrombie Radiology
Knoxville, Tennessee, United States, 37909
The University of Tennessee
Knoxville, Tennessee, United States, 37996
Sponsors and Collaborators
The University of Tennessee, Knoxville
DePuy Synthes
Investigators
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Principal Investigator: Richard Komistek, Ph. D. The University of Tennessee
  Study Documents (Full-Text)

Documents provided by Richard Komistek, The University of Tennessee, Knoxville:
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Responsible Party: Richard Komistek, Fred M. Roddy Professor of Biomedical Engineering, The University of Tennessee, Knoxville
ClinicalTrials.gov Identifier: NCT02682602    
Other Study ID Numbers: 2631FB
IIS-14002 ( Other Grant/Funding Number: DePuy Synthes )
First Posted: February 15, 2016    Key Record Dates
Results First Posted: November 8, 2019
Last Update Posted: November 25, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Richard Komistek, The University of Tennessee, Knoxville:
total hip arthroplasty
Additional relevant MeSH terms:
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Hip Injuries
Wounds and Injuries
Tacrine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents