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| Name | Class |
|---|---|
| Stryker Nordic | INDUSTRY |
| West Penn Allegheny Health System | OTHER |
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This study will involve a quantitative assessment of prospectively collected computed tomography, radiographic and patient outcomes data from multiple centers. Specifically looking at acetabular cup placement during Total Hip Arthroplasty by either traditional or robotic-arm assisted placement.
The incidence of dislocation following total hip arthroplasty (THA) has been reported to be from 1% to as much as 3.2%. The demand for THA is expected to increase. Post- dislocation solutions include closed reduction, open reduction, THA revision, and constrained cup, conversion to hemiarthroplasty, allograft or girdlestone resection. These solutions are often costly, painful and can involve substantial additional risks and complications. Acetabular cup placement is an important factor in the stability of the THA. Cup malpositioning has been associated with bearing surface ware and dislocation. For most patients, acceptable angles for abduction are 40° abduction (±10°) and 20° (±5°) version. However, malpositioning continues to occur resulting in cup angles outside acceptable ranges and leaving patients with an increased risk of dislocation.
This objective of this study is to examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Traditional THA. | |
| Intervention | Active Comparator | Robotic-arm assisted THA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic-Arm Assisted THA | Procedure | The study will examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Version. | Accuracy of cup placement will be measured by absolute value of degrees from target version (40 degrees). Using CT (Computed Tomography) Scans, analysis and radiographs will allow for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis alone. | 6 months |
| Change in Patient Reported "Hip Dysfunction and Osteoarthritis Outcome Score" (HOOS) Survey Over 1 Year Period. | The hip disability and osteoarthritis outcome score (HOOS) is a questionnaire intended to be used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process . To interpret the score, the outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms. To calculate the total HOOS score the subscales need to be summed up. | 1 Year |
| Change in "Patient-Reported Outcomes Measurement Information System" (PROMIS) Survey Over a 1 Year Period. | The PROMIS Global-10 is a global health quality of life patient reported outcome tool. It is part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It measures symptoms, functioning, and healthcare quality of life for a wide variety of conditions. The PROMIS Global-10 consists of 10 questions assessing physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. 7 questions inquire about health in "general" and 3 questions assess emotional problems, fatigue and pain in the last 7 days. PROMIS 10 Global Physical Health- Scale range (0-20) and what the low number means vs the high number (ex 0 equals worse physical health and 20 equals the best physical health). PROMIS 10 Global Mental Health- Scale range (0-20) and what the low number means vs the high number (ex 0 equals worse mental health and 20 equals the best mental health) | 1year |
| Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Inclination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew J Dietz, MD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WVU Medicine | Morgantown | West Virginia | 26501 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26592900 | Background | Banerjee S, Cherian JJ, Elmallah RK, Pierce TP, Jauregui JJ, Mont MA. Robot-assisted total hip arthroplasty. Expert Rev Med Devices. 2016;13(1):47-56. doi: 10.1586/17434440.2016.1124018. Epub 2015 Dec 21. | |
| 26391264 | Background | Elson L, Dounchis J, Illgen R, Marchand RC, Padgett DE, Bragdon CR, Malchau H. Precision of acetabular cup placement in robotic integrated total hip arthroplasty. Hip Int. 2015 Nov-Dec;25(6):531-6. doi: 10.5301/hipint.5000289. Epub 2015 Sep 10. |
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All patient outcomes data will be entered by the on-site research assistant into the REDCap study site created and managed at the Principal Investigators institution by the primary research coordinator. The REDCap site will house the study data and provide a means for the remote site research assistant to enter patient demographics, medical history, surgical details and outcome results. Medical history, demographic, and surgical details.
The individual participant data (IPD) will be available from the beginning of enrollment until the manuscript is submitted and accepted
the study will utilize a digital imaging analysis program called the Martell Hip Analysis Suite (HAS, Chicago, IL) as well as Computed Tomography (CT) scans. Patient reported outcomes (HOOS, PROMIS10, Hip stability and return to function) will also be collected at specified intervals. Using CT Scans and HAS analysis allows for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Traditional THA. |
| FG001 | Intervention | Robotic-arm assisted THA. Robotic-Arm Assisted THA: The study will examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Traditional THA. |
| BG001 | Intervention | Robotic-arm assisted THA. Robotic-Arm Assisted THA: The study will examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Version. | Accuracy of cup placement will be measured by absolute value of degrees from target version (40 degrees). Using CT (Computed Tomography) Scans, analysis and radiographs will allow for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis alone. | Posted | Mean | Standard Deviation | degrees error in anteversion | 6 months |
|
1 year
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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 | Control | Traditional THA. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prosthetic Joint Infection | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brock A. Lindsey, MD | West Virginia University | 304-293-1317 | blindsey@hsc.wvu.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 | Aug 12, 2018 | Mar 20, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 22, 2019 | Mar 20, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Accuracy of cup placement will be measured by absolute value of degrees from target inclination (20 degrees). Using CT (Computed Tomography) Scans, analysis and radiographs will allow for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis alone. |
| 6 months |
| Adherence to Lewinnek Safe Zone | 5-25 degrees of anteversion; 30-50 degrees of inclination. | 6 month |
| 25453633 | Background | Kanawade V, Dorr LD, Banks SA, Zhang Z, Wan Z. Precision of robotic guided instrumentation for acetabular component positioning. J Arthroplasty. 2015 Mar;30(3):392-7. doi: 10.1016/j.arth.2014.10.021. Epub 2014 Oct 22. |
| 24574012 | Background | Werner SD, Stonestreet M, Jacofsky DJ. Makoplasty and the accuracy and efficacy of robotic-assisted arthroplasty. Surg Technol Int. 2014 Mar;24:302-6. |
| 21728013 | Background | Tarwala R, Dorr LD. Robotic assisted total hip arthroplasty using the MAKO platform. Curr Rev Musculoskelet Med. 2011 Sep;4(3):151-6. doi: 10.1007/s12178-011-9086-7. |
| 20717858 | Background | Callanan MC, Jarrett B, Bragdon CR, Zurakowski D, Rubash HE, Freiberg AA, Malchau H. The John Charnley Award: risk factors for cup malpositioning: quality improvement through a joint registry at a tertiary hospital. Clin Orthop Relat Res. 2011 Feb;469(2):319-29. doi: 10.1007/s11999-010-1487-1. |
| 7142237 | Background | Woo RY, Morrey BF. Dislocations after total hip arthroplasty. J Bone Joint Surg Am. 1982 Dec;64(9):1295-306. |
| 641088 | Background | Lewinnek GE, Lewis JL, Tarr R, Compere CL, Zimmerman JR. Dislocations after total hip-replacement arthroplasties. J Bone Joint Surg Am. 1978 Mar;60(2):217-20. |
| 23990446 | Background | Domb BG, El Bitar YF, Sadik AY, Stake CE, Botser IB. Comparison of robotic-assisted and conventional acetabular cup placement in THA: a matched-pair controlled study. Clin Orthop Relat Res. 2014 Jan;472(1):329-36. doi: 10.1007/s11999-013-3253-7. Epub 2013 Aug 29. |
| 26365088 | Background | Banerjee S, Cherian JJ, Elmallah RK, Jauregui JJ, Pierce TP, Mont MA. Robotic-assisted knee arthroplasty. Expert Rev Med Devices. 2015;12(6):727-35. doi: 10.1586/17434440.2015.1086264. Epub 2015 Sep 12. |
| 25435041 | Background | Roche M. Robotic-assisted unicompartmental knee arthroplasty: the MAKO experience. Orthop Clin North Am. 2015 Jan;46(1):125-31. doi: 10.1016/j.ocl.2014.09.008. |
| 15469226 | Background | Soong M, Rubash HE, Macaulay W. Dislocation after total hip arthroplasty. J Am Acad Orthop Surg. 2004 Sep-Oct;12(5):314-21. doi: 10.5435/00124635-200409000-00006. |
| 9917607 | Background | Pellicci PM, Bostrom M, Poss R. Posterior approach to total hip replacement using enhanced posterior soft tissue repair. Clin Orthop Relat Res. 1998 Oct;(355):224-8. doi: 10.1097/00003086-199810000-00023. |
| 19277802 | Background | Ghelman B, Kepler CK, Lyman S, Della Valle AG. CT outperforms radiography for determination of acetabular cup version after THA. Clin Orthop Relat Res. 2009 Sep;467(9):2362-70. doi: 10.1007/s11999-009-0774-1. Epub 2009 Mar 10. |
| 27064781 | Background | Redmond JM, Gupta A, Hammarstedt JE, Petrakos A, Stake CE, Domb BG. Accuracy of Component Placement in Robotic-Assisted Total Hip Arthroplasty. Orthopedics. 2016 May 1;39(3):193-9. doi: 10.3928/01477447-20160404-06. Epub 2016 Apr 12. |
| 26046996 | Background | El Bitar YF, Stone JC, Jackson TJ, Lindner D, Stake CE, Domb BG. Leg-Length Discrepancy After Total Hip Arthroplasty: Comparison of Robot-Assisted Posterior, Fluoroscopy-Guided Anterior, and Conventional Posterior Approaches. Am J Orthop (Belle Mead NJ). 2015 Jun;44(6):265-9. |
| 26253480 | Background | Gupta A, Redmond JM, Hammarstedt JE, Petrakos AE, Vemula SP, Domb BG. Does Robotic-Assisted Computer Navigation Affect Acetabular Cup Positioning in Total Hip Arthroplasty in the Obese Patient? A Comparison Study. J Arthroplasty. 2015 Dec;30(12):2204-7. doi: 10.1016/j.arth.2015.06.062. Epub 2015 Jul 2. |
| 27728953 | Background | Bukowski BR, Anderson P, Khlopas A, Chughtai M, Mont MA, Illgen RL 2nd. Improved Functional Outcomes with Robotic Compared with Manual Total Hip Arthroplasty. Surg Technol Int. 2016 Oct 26;29:303-308. |
| 27499519 | Background | Kamara E, Robinson J, Bas MA, Rodriguez JA, Hepinstall MS. Adoption of Robotic vs Fluoroscopic Guidance in Total Hip Arthroplasty: Is Acetabular Positioning Improved in the Learning Curve? J Arthroplasty. 2017 Jan;32(1):125-130. doi: 10.1016/j.arth.2016.06.039. Epub 2016 Jun 29. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Change in Patient Reported "Hip Dysfunction and Osteoarthritis Outcome Score" (HOOS) Survey Over 1 Year Period. | The hip disability and osteoarthritis outcome score (HOOS) is a questionnaire intended to be used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process . To interpret the score, the outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms. To calculate the total HOOS score the subscales need to be summed up. | Posted | Mean | Standard Deviation | score on a scale | 1 Year |
|
|
|
| Primary | Change in "Patient-Reported Outcomes Measurement Information System" (PROMIS) Survey Over a 1 Year Period. | The PROMIS Global-10 is a global health quality of life patient reported outcome tool. It is part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It measures symptoms, functioning, and healthcare quality of life for a wide variety of conditions. The PROMIS Global-10 consists of 10 questions assessing physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. 7 questions inquire about health in "general" and 3 questions assess emotional problems, fatigue and pain in the last 7 days. PROMIS 10 Global Physical Health- Scale range (0-20) and what the low number means vs the high number (ex 0 equals worse physical health and 20 equals the best physical health). PROMIS 10 Global Mental Health- Scale range (0-20) and what the low number means vs the high number (ex 0 equals worse mental health and 20 equals the best mental health) | Posted | Mean | Standard Deviation | score on a scale | 1year |
|
|
|
| Primary | Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Inclination. | Accuracy of cup placement will be measured by absolute value of degrees from target inclination (20 degrees). Using CT (Computed Tomography) Scans, analysis and radiographs will allow for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis alone. | Posted | Mean | Standard Deviation | degrees error in inclination | 6 months |
|
|
|
| Primary | Adherence to Lewinnek Safe Zone | 5-25 degrees of anteversion; 30-50 degrees of inclination. | Posted | Count of Participants | Participants | 6 month |
|
|
|
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Intervention | Robotic-arm assisted THA. Robotic-Arm Assisted THA: The study will examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA. | 0 | 20 | 1 | 20 | 0 | 20 |
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| D012216 |
| Rheumatic Diseases |
| HOOS Symptoms |
|
| HOOS QOL (quality of life) |
|
| HOOS Sports/recreation |
|