N/A
N=21
THA Kinematics and Sound for Subjects for Normal, Diseased and Implanted Hips
Hip Injuries
Bottom Line
View on ClinicalTrials.gov: NCT02682602 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Magnitude of Hip Separation During Primary Heel Strike — -0.591; 0.096; 0.558 mm
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- DePuy Synthes total hip arthroplasty (Device); Computer tomography (Radiation); Fluoroscopy surveillance (Radiation)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- The University of Tennessee, Knoxville
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Magnitude of Hip Separation During Primary Heel Strike |
-0.591; 0.096; 0.558 | — |
| PRIMARY Magnitude of Hip Separation During Contra-lateral Toe Off |
-1.051; -0.065; 1.593 | — |
| PRIMARY Magnitude of Hip Separation During Contra-lateral Heel Strike |
-1.019; -0.344; 0.566 | — |
| PRIMARY Magnitude of Hip Separation During Primary Toe Off |
-0.936; -0.143; 0.512 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02682602). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.