Hip Injuries
Conditions
Keywords
Surgical approach, Direct-anterior, Anterior-lateral, Posterior-lateral, Hip implant, Total Hip Arthroplasty, Total Hip replacement, Hip replacement, Hip prosthesis
Brief summary
In a previous study conducted within the Center for Musculoskeletal Research (CMR) on Total Hip Arthroplasties (THA), it was determined that the investigators could simultaneously capture in vivo sound and motion of the femoral head within the acetabular cup during weight-bearing activities for subjects implanted with either a metal-on-polyethylene (MOP), metal-on-metal (MOM) or ceramic-on-ceramic (COC) THA. This was the first study to apply sound analysis as an impulse excitation technique for testing hip conditions and for measuring femoral head sliding in the acetabular component of human hip joints by acoustic means. Unfortunately, no studies have been conducted to compare the in vivo kinematics and sound for subjects implanted using various surgical approaches. It could be hypothesized that subjects having various surgical approaches could lead to an increase or reduction of in vivo hip separation. Therefore, the objective of this study is to analyze a total of 30 subjects implanted with either an anterior (10 patients), anterior-lateral (10 patients), or posterior-lateral (10 patients) surgical approach to determine if any of these surgical approaches leads to less or more in vivo hip separation. All subjects will be analyzed under in vivo weight-bearing conditions using video fluoroscopy to determine in vivo motion.
Interventions
RADIATIONFluoroscopy surveillance of patients while walking
While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
Sponsors
DePuy Orthopaedics
The University of Tennessee, Knoxville
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Post-operative clinical evaluation judged successful using Harris Hip Scoring (HHS) system (HHS\>90) * Body weight less than 270 lbs * No evidence of post-operative hip subluxation or dislocation * Do not walk with detectable limp * Be able to actively abduct their operated hip against gravity without difficulty * Must be willing to sign Informed Consent and Health Insurance Portability and Accountability (HIPAA) forms
Exclusion criteria
* Pregnant, lactating or females not using reliable form of birth control * Patients that do not meet study requirements * Patients unwilling to sign Informed Consent or HIPAA forms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kinematics - Swing Phase Separation | 6 months post-operatively | Determine amount of in vivo swing phase hip separation present within implanted hip during weight-bearing level walking while under fluoroscopic surveillance. |
| Kinematics - Stance Phase Separation | 6 months post-operative | Determine amount of stance phase hip separation present in vivo of implanted hip during level walking activity under fluoroscopic surveillance. |
| Kinematics - Overall Separation | 6 months post-operative | Determine overall hip separation present in vivo in implanted hip during level walking activity under fluoroscopic surveillance |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| THA Using Direct-anterior Surgical Approach Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking. | 10 |
| THA Using Anterior-lateral Approach Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking. | 10 |
| THA Using Posterior-lateral Approach Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking. | 10 |
| Total | 30 |
Baseline characteristics
| Characteristic | Total | THA Using Direct-anterior Surgical Approach | THA Using Anterior-lateral Approach | THA Using Posterior-lateral Approach |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 4 Participants | 7 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 6 Participants | 3 Participants | 3 Participants |
| Age, Continuous | 66 years STANDARD_DEVIATION 7.4 | 63 years STANDARD_DEVIATION 7.3 | 67 years STANDARD_DEVIATION 5.4 | 69 years STANDARD_DEVIATION 8.7 |
| Region of Enrollment Canada | 10 participants | 0 participants | 10 participants | 0 participants |
| Region of Enrollment United States | 20 participants | 10 participants | 0 participants | 10 participants |
| Sex: Female, Male Female | 18 Participants | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 12 Participants | 5 Participants | 6 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Kinematics - Overall Separation
Determine overall hip separation present in vivo in implanted hip during level walking activity under fluoroscopic surveillance
Time frame: 6 months post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THA Using Direct-anterior Surgical Approach | Kinematics - Overall Separation | 1.1 mm | Standard Deviation 0.6 |
| THA Using Anterior-lateral Approach | Kinematics - Overall Separation | 0.8 mm | Standard Deviation 0.6 |
| THA Using Posterior-lateral Approach | Kinematics - Overall Separation | 1.2 mm | Standard Deviation 0.4 |
Primary
Kinematics - Stance Phase Separation
Determine amount of stance phase hip separation present in vivo of implanted hip during level walking activity under fluoroscopic surveillance.
Time frame: 6 months post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THA Using Direct-anterior Surgical Approach | Kinematics - Stance Phase Separation | 0.9 mm | Standard Deviation 0.3 |
| THA Using Anterior-lateral Approach | Kinematics - Stance Phase Separation | 0.8 mm | Standard Deviation 0.6 |
| THA Using Posterior-lateral Approach | Kinematics - Stance Phase Separation | 1.0 mm | Standard Deviation 0.3 |
Primary
Kinematics - Swing Phase Separation
Determine amount of in vivo swing phase hip separation present within implanted hip during weight-bearing level walking while under fluoroscopic surveillance.
Time frame: 6 months post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THA Using Direct-anterior Surgical Approach | Kinematics - Swing Phase Separation | 0.9 mm | Standard Deviation 0.7 |
| THA Using Anterior-lateral Approach | Kinematics - Swing Phase Separation | 0.6 mm | Standard Deviation 0.3 |
| THA Using Posterior-lateral Approach | Kinematics - Swing Phase Separation | 1.0 mm | Standard Deviation 0.4 |