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| ID | Type | Description | Link |
|---|---|---|---|
| R01 1373 452 | Other Identifier | University of Tennessee | |
| 13-0372 | Other Identifier | University of Tennessee |
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| Name | Class |
|---|---|
| DePuy Orthopaedics | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THA using direct-anterior surgical approach | Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking. |
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| THA using anterior-lateral approach | Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking. |
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| THA using posterior-lateral approach | Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoroscopy surveillance of patients while walking | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months post-operatively |
| Kinematics - Stance Phase Separation | Determine amount of stance phase hip separation present in vivo of implanted hip during level walking activity under fluoroscopic surveillance. | 6 months post-operative |
| Kinematics - Overall Separation | Determine overall hip separation present in vivo in implanted hip during level walking activity under fluoroscopic surveillance | 6 months post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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Patients implanted with a direct-anterior surgical approach will be provided by Dr. William Barrett of Valley Orthopedic Associates in Renton, WA.
Patients implanted with an anterior-lateral surgical approach will be provided by Dr. of Steven J. MacDonald of the London Health Sciences Center, London, Ontario.
Patients implanted with a posterior-lateral approach will be provided by Dr. David F. Dalury of Towson Orthopaedic Associates, Inc. in Towson, MD.
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| Name | Affiliation | Role |
|---|---|---|
| Richard D Komistek, Ph D | The University of Tennessee | Principal Investigator |
| Adrija Sharma, Ph D | The University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland St. Joseph Medical Center | Towson | Maryland | 21201 | United States | ||
| Valley Orthopedic Associates ASC |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | mm | 6 months post-operatively |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard D. Komistek | University of Tennessee | 8659742093 | rkomiste@utk.edu |
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| ID | Term |
|---|---|
| D025981 | Hip Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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|
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| Renton |
| Washington |
| 90855 |
| United States |
| University Hospital | London | Ontario | N6A 5A5 | Canada |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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. |
| OG002 | 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. |
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| 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. | Posted | Mean | Standard Deviation | mm | 6 months post-operative |
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| Primary | Kinematics - Overall Separation | Determine overall hip separation present in vivo in implanted hip during level walking activity under fluoroscopic surveillance | Posted | Mean | Standard Deviation | mm | 6 months post-operative |
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| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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. | 0 | 10 | 0 | 10 |
| EG002 | 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. | 0 | 10 | 0 | 10 |
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