Measured vs Navigated Techniques in Total Hip Arthroplasty
25 мая 2022 г. обновлено: Ottawa Hospital Research Institute
Accuracy in aChieving Optimum reconstrUction: Measured- vs. Navigation- Techniques in Hip Arthroplasty
Accurate reconstruction of the native hip parameters following total hip arthroplasty is associated with improved outcome.
In order to improve ability for optimum reconstruction, 3-D templating software can be utilized that provide detailed information regarding native anatomy.
In order to achieve reconstruction within acceptable parameters as per pre-operative plan, some surgeons propose the use of intra-operative devices that measure component orientation and joint reconstruction ("Measured-THA"), whilst others propose the use of navigation tools ("Navigation-THA).
Both techniques have shown superiority compared to the most commonly used "freehand" technique, but no prior study has assessed for superiority between these 2 techniques.
Furthermore, to-date assessment of post-operative reconstruction has not been tested in detail as post-THA assessments are based on radiographs which provide incomplete, 2-dimensional, assessments and are lacking the important axial plane reconstruction parameters.
The aims of this prospective, randomized, trial are to 1. appraise the ability to achieve the pre-operative 3-D plan (as per FormusLab) through a comparison of pre-op plan to post-operative reconstruction; 2. compare ability to accurately reconstruct hip following THA between "navigated-" (IntelliJoint®) and "measured-" techniques; and in doing so it will also 3. assess the accuracy of the intra-operative assessments of reconstruction through a comparison of objective (i.e.
measured) intra-operative assessments with the post-operative reconstructions achieved.
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Ожидаемый)
100
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Isabel Horton
- Номер телефона: 73032 613-737-8899
- Электронная почта: ihorton@ohri.ca
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Patients who are signed for a THA for primary or secondary osteoarthritis without overt deformity that would require revision type implants and with good enough bone quality to be listed for uncemented component implantation.
Exclusion Criteria:
- Secondary OA due to Dysplasia (Hartofilakidis >1)
- Avascular necrosis of the hip with destruction of joint structure
- Sequelae of Pediatric deformity with abnormal anatomy
- Cemented fixation of femur or acetabulum
- Previous arthroplasty-type procedure
- Previous septic arthritis of the hip
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Measured Technique
Patients in this group will have pre-operative planning done using the measured technique.
|
Manual intra-operative checks and tools are used to aid in component placement during surgery.
|
|
Экспериментальный: Navigated Technique
Patients in this group will have pre-operative planning done using the navigated technique.
|
IntelliJoint® navigation is an imageless-based navigation system that utilizes a miniature infrared camera and microelectronics to measure hip center of rotation, acetabular inclination and version, leg length, and offset.
The device provides accurate real-time data on implant positioning to aid in placement of the components during surgery.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Pain Assessment - Oxford Hip Score
Временное ограничение: once pre-operatively and once one-year post-operatively
|
The Oxford Hip Score will be given to patients to assess subjective measures of hip pain.
Scores for each question from 0 to 4 with 4 being the best outcome.
This method, when summed, produces overall scores running from 0 to 48 with 48 being the best outcome
|
once pre-operatively and once one-year post-operatively
|
|
Change in mobility, self-care, usual activities, pain/discomfort and anxiety/depression- EuroQol
Временное ограничение: once pre-operatively and once one-year post-operatively
|
the EuroQol (EQ-5D-5L) will be given to patients to assess subjective measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems. |
once pre-operatively and once one-year post-operatively
|
|
Change in physical, mental, and social health- PROMIS Global-10
Временное ограничение: once pre-operatively and once one-year post-operatively
|
the PROMIS Global-10 will be given to patients to assess subjective measures of physical, mental and social health.
It is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales.
The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score.
Higher scores indicate worse physical and mental health
|
once pre-operatively and once one-year post-operatively
|
|
Adverse Events
Временное ограничение: 90 days post-operatively
|
Serious adverse events will be monitored. This includes:
|
90 days post-operatively
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Accuracy of reconstruction (in mm)
Временное ограничение: post-operatively (within one week post-operatively)
|
A measure (in mm) of how close the planned to actual reconstruction using the aforementioned reconstruction parameters. This will be assessed using:
|
post-operatively (within one week post-operatively)
|
|
Comparison of margin of error
Временное ограничение: Through study completion, an average of 1 year
|
This outcome will measure what the margin of error is between intra-operatively measured values and those determined from the post-operative CT scan.
This will be done using statistical analysis of data for patients in both study arms.
|
Through study completion, an average of 1 year
|
|
Accuracy of reconstruction on outcome
Временное ограничение: Through study completion, an average of 1 year
|
This outcome measure will assess the accuracy of reconstruction correlate with outcome (adverse events and PROMs).
This will be done by analyzing accuracy as depicted by the variables in outcome measure 5, and how these measures of accuracy correlate to patient reported outcome measure scores and rates of adverse events
|
Through study completion, an average of 1 year
|
|
Accuracy of reconstruction (in degrees)
Временное ограничение: post-operatively (within one week post-operatively)
|
A measure (in degrees) of how close the planned to actual reconstruction using the aforementioned reconstruction parameters. This will be assessed using: Acetabular component orientation (Radiographic inclination/anteversion in degrees as per Murray)
|
post-operatively (within one week post-operatively)
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Соавторы
Следователи
- Главный следователь: George Grammatopoulos, MD, The Ottawa Hospital
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
- Grammatopoulos G, Thomas GE, Pandit H, Beard DJ, Gill HS, Murray DW. The effect of orientation of the acetabular component on outcome following total hip arthroplasty with small diameter hard-on-soft bearings. Bone Joint J. 2015 Feb;97-B(2):164-72. doi: 10.1302/0301-620X.97B2.34294.
- Meermans G, Goetheer-Smits I, Lim RF, Van Doorn WJ, Kats J. The difference between the radiographic and the operative angle of inclination of the acetabular component in total hip arthroplasty: use of a digital protractor and the circumference of the hip to improve orientation. Bone Joint J. 2015 May;97-B(5):603-10. doi: 10.1302/0301-620X.97B5.34781.
- Fang CJ, Shaker JM, Ward DM, Jawa A, Mattingly DA, Smith EL. Financial Burden of Revision Hip and Knee Arthroplasty at an Orthopedic Specialty Hospital: Higher Costs and Unequal Reimbursements. J Arthroplasty. 2021 Aug;36(8):2680-2684. doi: 10.1016/j.arth.2021.03.044. Epub 2021 Mar 23.
- Hu X, Zheng N, Chen Y, Dai K, Dimitriou D, Li H, Tsai TY. Optimizing the Femoral Offset for Restoring Physiological Hip Muscle Function in Patients With Total Hip Arthroplasty. Front Bioeng Biotechnol. 2021 Mar 30;9:645019. doi: 10.3389/fbioe.2021.645019. eCollection 2021.
- Agarwal S, Eckhard L, Walter WL, Peng A, Hatton A, Donnelly B, de Steiger R. The Use of Computer Navigation in Total Hip Arthroplasty Is Associated with a Reduced Rate of Revision for Dislocation: A Study of 6,912 Navigated THA Procedures from the Australian Orthopaedic Association National Joint Replacement Registry. J Bone Joint Surg Am. 2021 Oct 20;103(20):1900-1905. doi: 10.2106/JBJS.20.00950.
- Shon WY, Baldini T, Peterson MG, Wright TM, Salvati EA. Impingement in total hip arthroplasty a study of retrieved acetabular components. J Arthroplasty. 2005 Jun;20(4):427-35. doi: 10.1016/j.arth.2004.09.058.
- Barrack RL, Krempec JA, Clohisy JC, McDonald DJ, Ricci WM, Ruh EL, Nunley RM. Accuracy of acetabular component position in hip arthroplasty. J Bone Joint Surg Am. 2013 Oct 2;95(19):1760-8. doi: 10.2106/JBJS.L.01704.
- Bosker BH, Verheyen CC, Horstmann WG, Tulp NJ. Poor accuracy of freehand cup positioning during total hip arthroplasty. Arch Orthop Trauma Surg. 2007 Jul;127(5):375-9. doi: 10.1007/s00402-007-0294-y. Epub 2007 Feb 13.
- Schwarzkopf R, Muir JM, Paprosky WG, Seymour S, Cross MB, Vigdorchik JM. Quantifying Pelvic Motion During Total Hip Arthroplasty Using a New Surgical Navigation Device. J Arthroplasty. 2017 Oct;32(10):3056-3060. doi: 10.1016/j.arth.2017.04.046. Epub 2017 May 4.
- Pongkunakorn A, Chatmaitri S, Diewwattanawiwat K. Use of smartphone to improve acetabular component positioning in total hip athroplasty: A comparative clinical study. J Orthop Surg (Hong Kong). 2019 Jan-Apr;27(1):2309499019825578. doi: 10.1177/2309499019825578. Erratum In: J Orthop Surg (Hong Kong). 2019 Jan-Apr;27(1):2309499019834501.
- Gupta R, Pathak P, Singh R, Majumdar KP. Double-Stitch Technique: A Simple and Effective Method to Minimize Limb Length Discrepancy after Total Hip Arthroplasty. Indian J Orthop. 2019 Jan-Feb;53(1):169-173. doi: 10.4103/ortho.IJOrtho_188_18.
- Mitsutake R, Tanino H, Nishida Y, Higa M, Ito H. A simple angle-measuring instrument for measuring cemented stem anteversion during total hip arthroplasty. BMC Musculoskelet Disord. 2020 Feb 19;21(1):113. doi: 10.1186/s12891-020-3142-7.
- Steppacher SD, Kowal JH, Murphy SB. Improving cup positioning using a mechanical navigation instrument. Clin Orthop Relat Res. 2011 Feb;469(2):423-8. doi: 10.1007/s11999-010-1553-8.
- Meermans G, Van Doorn WJ, Koenraadt K, Kats J. The use of the transverse acetabular ligament for determining the orientation of the components in total hip replacement: a randomised controlled trial. Bone Joint J. 2014 Mar;96-B(3):312-8. doi: 10.1302/0301-620X.96B3.32989.
- Paprosky WG, Muir JM. Intellijoint HIP(R): a 3D mini-optical navigation tool for improving intraoperative accuracy during total hip arthroplasty. Med Devices (Auckl). 2016 Nov 18;9:401-408. doi: 10.2147/MDER.S119161. eCollection 2016.
- Parvizi J, Benson JR, Muir JM. A new mini-navigation tool allows accurate component placement during anterior total hip arthroplasty. Med Devices (Auckl). 2018 Mar 22;11:95-104. doi: 10.2147/MDER.S151835. eCollection 2018.
- Kievit AJ, Dobbe JGG, Mallee WH, Blankevoort L, Streekstra GJ, Schafroth MU. Accuracy of cup placement in total hip arthroplasty by means of a mechanical positioning device: a comprehensive cadaveric 3d analysis of 16 specimens. Hip Int. 2021 Jan;31(1):58-65. doi: 10.1177/1120700019874822. Epub 2019 Sep 11.
- Snijders T, van Gaalen SM, de Gast A. Precision and accuracy of imageless navigation versus freehand implantation of total hip arthroplasty: A systematic review and meta-analysis. Int J Med Robot. 2017 Dec;13(4). doi: 10.1002/rcs.1843. Epub 2017 May 29.
- Singh V, Realyvasquez J, Simcox T, Rozell JC, Schwarzkopf R, Davidovitch RI. Robotics Versus Navigation Versus Conventional Total Hip Arthroplasty: Does the Use of Technology Yield Superior Outcomes? J Arthroplasty. 2021 Aug;36(8):2801-2807. doi: 10.1016/j.arth.2021.02.074. Epub 2021 Mar 5.
- Koper MC, Reijman M, van Es EM, Waarsing JH, Koot HWJ, Keizer SB, Jansen I, van Biezen FC, Verhaar JAN, Bos PK. No added value for Computer-Assisted surgery to improve femoral component positioning and Patient Reported Outcomes in Hip Resurfacing Arthroplasty; a multi-center randomized controlled trial. BMC Musculoskelet Disord. 2019 Oct 25;20(1):473. doi: 10.1186/s12891-019-2883-7.
- Innmann MM, Maier MW, Streit MR, Grammatopoulos G, Bruckner T, Gotterbarm T, Merle C. Additive Influence of Hip Offset and Leg Length Reconstruction on Postoperative Improvement in Clinical Outcome After Total Hip Arthroplasty. J Arthroplasty. 2018 Jan;33(1):156-161. doi: 10.1016/j.arth.2017.08.007. Epub 2017 Aug 12.
- Schiffner E, Latz D, Jungbluth P, Grassmann JP, Tanner S, Karbowski A, Windolf J, Schneppendahl J. Is computerised 3D templating more accurate than 2D templating to predict size of components in primary total hip arthroplasty? Hip Int. 2019 May;29(3):270-275. doi: 10.1177/1120700018776311. Epub 2018 May 20.
- Minoda Y, Ohzono K, Aihara M, Umeda N, Tomita M, Hayakawa K. Are acetabular component alignment guides for total hip arthroplasty accurate? J Arthroplasty. 2010 Sep;25(6):986-9. doi: 10.1016/j.arth.2009.07.016. Epub 2009 Oct 17.
- Beverland DE, O'Neill CK, Rutherford M, Molloy D, Hill JC. Placement of the acetabular component. Bone Joint J. 2016 Jan;98-B(1 Suppl A):37-43. doi: 10.1302/0301-620X.98B1.36343.
- Bonnin MP, Archbold PH, Basiglini L, Fessy MH, Beverland DE. Do we medialise the hip centre of rotation in total hip arthroplasty? Influence of acetabular offset and surgical technique. Hip Int. 2012 Jul-Aug;22(4):371-8. doi: 10.5301/HIP.2012.9350.
- Merle C, Innmann MM, Waldstein W, Pegg EC, Aldinger PR, Gill HS, Murray DW, Grammatopoulos G. High Variability of Acetabular Offset in Primary Hip Osteoarthritis Influences Acetabular Reaming-A Computed Tomography-Based Anatomic Study. J Arthroplasty. 2019 Aug;34(8):1808-1814. doi: 10.1016/j.arth.2019.03.065. Epub 2019 Apr 1.
- Lee YK, Kim JW, Kim TY, Ha YC, Koo KH. Validity of the intra-operative measurement of stem anteversion and factors for the erroneous estimation in cementless total hip arthroplasty using postero-lateral approach. Orthop Traumatol Surg Res. 2018 May;104(3):341-346. doi: 10.1016/j.otsr.2017.11.023. Epub 2018 Feb 16.
- Dorr LD, Wan Z, Malik A, Zhu J, Dastane M, Deshmane P. A comparison of surgeon estimation and computed tomographic measurement of femoral component anteversion in cementless total hip arthroplasty. J Bone Joint Surg Am. 2009 Nov;91(11):2598-604. doi: 10.2106/JBJS.H.01225.
- Blumenfeld TJ. Pearls: Clinical Application of Ranawat's Sign. Clin Orthop Relat Res. 2017 Jul;475(7):1789-1790. doi: 10.1007/s11999-017-5376-8. Epub 2017 May 11. No abstract available.
- Dorr LD, Malik A, Dastane M, Wan Z. Combined anteversion technique for total hip arthroplasty. Clin Orthop Relat Res. 2009 Jan;467(1):119-27. doi: 10.1007/s11999-008-0598-4. Epub 2008 Nov 1.
- Amuwa C, Dorr LD. The combined anteversion technique for acetabular component anteversion. J Arthroplasty. 2008 Oct;23(7):1068-70. doi: 10.1016/j.arth.2008.04.025. Epub 2008 Jun 4.
- Ogawa T, Takao M, Hamada H, Sakai T, Sugano N. Soft tissue tension is four times lower in the unstable primary total hip arthroplasty. Int Orthop. 2018 Sep;42(9):2059-2065. doi: 10.1007/s00264-018-3908-9. Epub 2018 Mar 27.
- Hill JC, Archbold HA, Diamond OJ, Orr JF, Jaramaz B, Beverland DE. Using a calliper to restore the centre of the femoral head during total hip replacement. J Bone Joint Surg Br. 2012 Nov;94(11):1468-74. doi: 10.1302/0301-620X.94B11.29144.
- Dorr LD, Hishiki Y, Wan Z, Newton D, Yun A. Development of imageless computer navigation for acetabular component position in total hip replacement. Iowa Orthop J. 2005;25:1-9.
- Jacob I, Benson J, Shanaghan K, Gonzalez Della Valle A. Acetabular positioning is more consistent with the use of a novel miniature computer-assisted device. Int Orthop. 2020 Mar;44(3):429-435. doi: 10.1007/s00264-020-04484-2. Epub 2020 Jan 22.
- Christ A, Ponzio D, Pitta M, Carroll K, Muir JM, Sculco PK. Minimal Increase in Total Hip Arthroplasty Surgical Procedural Time with the Use of a Novel Surgical Navigation Tool. Open Orthop J. 2018 Sep 28;12:389-395. doi: 10.2174/1874325001812010389. eCollection 2018.
- Murray DW. The definition and measurement of acetabular orientation. J Bone Joint Surg Br. 1993 Mar;75(2):228-32. doi: 10.1302/0301-620X.75B2.8444942.
- Gross AE, Safir OA, Kuzyk PRT, Sculco PK, Wolfstadt J, Girardi BL, et al. Optimizing leg length and cup position: A surgical navigation tool. Seminars in Arthroplasty. 2018;29(3):157-60.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Ожидаемый)
1 июля 2022 г.
Первичное завершение (Ожидаемый)
1 июля 2024 г.
Завершение исследования (Ожидаемый)
1 сентября 2024 г.
Даты регистрации исследования
Первый отправленный
10 декабря 2021 г.
Впервые представлено, что соответствует критериям контроля качества
25 мая 2022 г.
Первый опубликованный (Действительный)
26 мая 2022 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
26 мая 2022 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
25 мая 2022 г.
Последняя проверка
1 мая 2022 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 3390
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Measured Technique
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University of LahoreЗавершенныйВерхние триггерные точки трапециевидной мышцыПакистан
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Regional Cardiology Center, The Copper Health Centre...Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica...РекрутингВопросы безопасности | Эффективность, СамПольша