Hip Injuries
Conditions
Keywords
total hip arthroplasty
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.
Interventions
DEVICEDePuy Synthes total hip arthroplasty
RADIATIONComputer tomography
Computer tomography (CT) scan of the hip for creation of bone models.
RADIATIONFluoroscopy 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.
Sponsors
DePuy Synthes
The University of Tennessee, Knoxville
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Magnitude of Hip Separation During Primary Heel Strike | 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. |
| Magnitude of Hip Separation During Contra-lateral Toe Off | 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. |
| Magnitude of Hip Separation During Contra-lateral Heel Strike | 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. |
| Magnitude of Hip Separation During Primary Toe Off | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diseased/Implanted Hip Subjects with 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. | 11 |
| Normal Hip Subjects with a normal hip. | 10 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Post-operative Fluoroscopy for Implanted | Lost to Follow-up | 3 | 0 |
| Pre-operative Diseased & Normal Hips | Unusable images | 1 | 0 |
Baseline characteristics
| Characteristic | Normal Hip | Total | Diseased/Implanted Hip |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 9 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 11 Participants | 6 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 10 participants | 17 participants | 10 participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 11 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 10 | 0 / 7 |
| other Total, other adverse events | 0 / 11 | 0 / 10 | 0 / 7 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 | 0 / 7 |
Outcome results
Primary
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.
Time frame: Approximately 2 years postoperatively.
Population: All Diseased Hip subjects were re-analyzed approximately 2 years postoperatively to yield the Implanted Hip group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diseased Hip (Baseline) | Magnitude of Hip Separation During Contra-lateral Heel Strike | -1.019 mm | Standard Deviation 1.808 |
| Normal Hip | Magnitude of Hip Separation During Contra-lateral Heel Strike | -0.344 mm | Standard Deviation 1.518 |
| Implanted Hip | Magnitude of Hip Separation During Contra-lateral Heel Strike | 0.566 mm | Standard Deviation 0.188 |
Primary
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.
Time frame: Approximately 2 years postoperatively.
Population: All Diseased Hip subjects were re-analyzed approximately 2 years postoperatively to yield the Implanted Hip group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diseased Hip (Baseline) | Magnitude of Hip Separation During Contra-lateral Toe Off | -1.051 mm | Standard Deviation 1.235 |
| Normal Hip | Magnitude of Hip Separation During Contra-lateral Toe Off | -0.065 mm | Standard Deviation 0.986 |
| Implanted Hip | Magnitude of Hip Separation During Contra-lateral Toe Off | 1.593 mm | Standard Deviation 0.307 |
Primary
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.
Time frame: Approximately 2 years postoperatively.
Population: All Diseased Hip subjects were re-analyzed approximately 2 years postoperatively to yield the Implanted Hip group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diseased Hip (Baseline) | Magnitude of Hip Separation During Primary Heel Strike | -0.591 mm | Standard Deviation 1.582 |
| Normal Hip | Magnitude of Hip Separation During Primary Heel Strike | 0.096 mm | Standard Deviation 1.369 |
| Implanted Hip | Magnitude of Hip Separation During Primary Heel Strike | 0.558 mm | Standard Deviation 0.326 |
Primary
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.
Time frame: Approximately 2 years postoperatively.
Population: All Diseased Hip subjects were re-analyzed approximately 2 years postoperatively to yield the Implanted Hip group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diseased Hip (Baseline) | Magnitude of Hip Separation During Primary Toe Off | -0.936 mm | Standard Deviation 1.243 |
| Normal Hip | Magnitude of Hip Separation During Primary Toe Off | -0.143 mm | Standard Deviation 1.305 |
| Implanted Hip | Magnitude of Hip Separation During Primary Toe Off | 0.512 mm | Standard Deviation 0.149 |