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

NCT02682602 | Completed Results FDA Device

• 2 other identifiers: 2631FBIIS-14002
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 3

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.

Conditions

Hip Injuries

Keywords

total hip arthroplasty

Outcome Measures

Primary Outcomes (4)

• Magnitude of Hip Separation During Primary Heel Strike

  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

  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

  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

  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.

Study Arms (3)

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; Radiation: Fluoroscopy surveillance

Normal Hip

Subjects will have a normal hip.

Radiation: Computer tomography; Radiation: Fluoroscopy surveillance

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; Radiation: Fluoroscopy surveillance

Interventions

DePuy Synthes total hip arthroplasty DEVICE

Also known as: DePuy Synthes Summit/Pinnacle THA, DePuy Synthes Corail/Pinnacle THA

Implanted Group

Computer tomography RADIATION

Computer tomography (CT) scan of the hip for creation of bone models.

Diseased Hip; Normal Hip

Fluoroscopy surveillance RADIATION

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.

Diseased Hip; Implanted Group; Normal Hip

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead
• DePuy Synthes: collaborator

Study Sites (3)

Northside Hospital- Forsyth , GA 30041

Cumming, Georgia, 30041, United States

Location

Abercrombie Radiology

Knoxville, Tennessee, 37909, United States

Location

The University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

MeSH Terms

Conditions

Hip Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Richard Komistek, Principal Investigator
• Organization: University of Tennessee

rkomiste@utk.edu

8659742093

Study Officials

• Richard Komistek, Ph. D.

  The University of Tennessee

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fred M. Roddy Professor of Biomedical Engineering

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: February 15, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: November 25, 2019
• Results First Posted: November 8, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)