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| ID | Type | Description | Link |
|---|---|---|---|
| IIS-14002 | Other Grant/Funding Number | DePuy Synthes |
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| Name | Class |
|---|---|
| DePuy Synthes | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diseased Hip | 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. |
| |
| Normal Hip | Subjects will have a normal hip. |
| |
| Implanted Group | All subjects from the Diseased Hip group were implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DePuy Synthes total hip arthroplasty | Device |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 2 years postoperatively. |
| 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. | Approximately 2 years postoperatively. |
| 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. | Approximately 2 years postoperatively. |
| 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. | Approximately 2 years postoperatively. |
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Inclusion Criteria for diseased/implanted subjects:
Exclusion Criteria for diseased/implanted subjects:
Inclusion Criteria for normal subjects:
Exclusion Criteria for normal subjects:
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Subjects with a diseased hip that requires THA. OR Subjects with a normal hip.
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| Name | Affiliation | Role |
|---|---|---|
| Richard Komistek, Ph. D. | The University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northside Hospital- Forsyth , GA 30041 | Cumming | Georgia | 30041 | United States | ||
| Abercrombie Radiology |
Researchers would like to retain this study data in our secure database so as to continue to add relevant, current data to our digital collection to help us work with manufacturers in the future to create better implants that last longer and will not require revision surgery. Participants will be asked if their study data may remain a part of the University of Tennessee's Center for Musculoskeletal Research data collection for use in future studies in the IC. Identifiers are automatically removed from the database upon entry into the secure server. Data shared with sponsors is de-identified.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Normal Hip | Subjects with a normal hip. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-operative Diseased & Normal Hips |
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| Post-operative Fluoroscopy for Implanted |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Normal Hip |
| 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, Categorical | One diseased hip subject's pre-operative data images collected from fluoroscopy were unusable and this subject did not participate in post-operative data collection, but participation in pre-operative fluoroscopy counts toward study enrollment. An additional subject was enrolled to attempt to acquire the ten data sets in the protocol. |
| 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 | 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. | All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group. | Posted | Mean | Standard Deviation | mm | Approximately 2 years postoperatively. |
|
approximately 2 years, 8 months
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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 | Diseased Hip | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Komistek, Principal Investigator | University of Tennessee | 8659742093 | rkomiste@utk.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 9, 2019 | Oct 23, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D025981 | Hip Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Computer tomography | Radiation | Computer tomography (CT) scan of the hip for creation of bone models. |
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| Fluoroscopy surveillance | Radiation | 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. |
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| Knoxville |
| Tennessee |
| 37909 |
| United States |
| The University of Tennessee | Knoxville | Tennessee | 37996 | United States |
| NOT COMPLETED |
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Subjects with a normal hip.
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
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| Sex: Female, Male | One subject's pre-operative fluoroscopy images were unusable and this subject did not participate in post-operative data collection. Participation in pre-operative fluoroscopy counts toward total study enrollment. | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | One subject's pre-operative fluoroscopy images were unusable and this subject did not participate in post-operative data collection. This subject's participation in pre-operative data collection counts toward study enrollment. | Number | participants |
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Subjects with a normal hip. |
| OG002 | Implanted Hip | Subjects from diseased hip group who were implanted with DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA. |
|
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| 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. | All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group. | Posted | Mean | Standard Deviation | mm | Approximately 2 years postoperatively. |
|
|
|
| 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. | All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group. | Posted | Mean | Standard Deviation | mm | Approximately 2 years postoperatively. |
|
|
|
| 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. | All "Diseased Hip" subjects were re-analyzed approximately 2 years postoperatively to yield the "Implanted Hip" group. | Posted | Mean | Standard Deviation | mm | Approximately 2 years postoperatively. |
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Normal Hip | Subjects will have a normal hip. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Implanted Group | Diseased hip subjects who were implanted with either DePuy Synthes Summit/Pinnacle total hip arthroplasty (THA) or the Corail/Pinnacle THA | 0 | 7 | 0 | 7 | 0 | 7 |
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