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

The University of Tennessee, Knoxville

Status: Completed

Conditions: Hip Injuries

Treatments: Radiation: Computer tomography; Radiation: Fluoroscopy surveillance; Device: DePuy Synthes total hip arthroplasty

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02682602

IIS-14002 (Other Grant/Funding Number)

2631FB

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

21 participants in 3 patient groups

Diseased Hip

Description:

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.

Treatment:

Radiation: Fluoroscopy surveillance

Radiation: Computer tomography

Normal Hip

Description:

Subjects will have a normal hip.

Treatment:

Radiation: Fluoroscopy surveillance

Radiation: Computer tomography

Implanted Group

Description:

All subjects from the Diseased Hip group were implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA

Treatment:

Device: DePuy Synthes total hip arthroplasty

Radiation: Fluoroscopy surveillance