Measured vs Navigated Techniques in Total Hip Arthroplasty
NCT ID: NCT05393778
Last Updated: 2022-05-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-07-01
Study Completion Date
2024-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Defining Optimum Cup Orientation for Hip Replacements Taking Into Account the Individual's Anatomy and Movement Patterns
NCT04633525
Hip Arthritis
Hip Osteoarthritis
UNKNOWN
NA
Dynamic Imaging of the Hip for Pre-operative Planning
NCT00605969
Femoroacetabular, Impingement
COMPLETED
NA
Mobility Assessment of Patients With Total Hip Arthroplasty
NCT00664508
Osteoarthritis
Arthroplasty
Hip Replacement
ACTIVE_NOT_RECRUITING
NA
Intraoperative Measurement Technique
NCT06173557
Total Hip
Limb Length Discrepancy
COMPLETED
Pillow Use During Total Hip Arthroplasty
NCT03825029
Arthroplasty, Replacement, Hip
Hip Replacement, Total
UNKNOWN
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Osteoarthritis, Hip
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Measured Technique
Patients in this group will have pre-operative planning done using the measured technique.
Group Type
EXPERIMENTAL
Measured Technique
Intervention Type
PROCEDURE
Manual intra-operative checks and tools are used to aid in component placement during surgery.
Navigated Technique
Patients in this group will have pre-operative planning done using the navigated technique.
Group Type
EXPERIMENTAL
Navigated Technique
Intervention Type
PROCEDURE
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Measured Technique
Manual intra-operative checks and tools are used to aid in component placement during surgery.
Intervention Type
PROCEDURE
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.
Intervention Type
PROCEDURE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
* 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
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
FormusLab
UNKNOWN
Sponsor Role
collaborator
Ottawa Hospital Research Institute
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
George Grammatopoulos, MD
Role: PRINCIPAL_INVESTIGATOR
The Ottawa Hospital
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3390
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Restoration of Leg Length, Offset, and Center of Rotation in Total Hip Replacement
NCT00738803
UNKNOWN
NA
Comparing Short-term Outcomes After Direct Anterior and SuperPATH Hip Arthroplasty Approaches
NCT03746925
UNKNOWN
NA
Patient-Specific Techniques for Hip Replacement
NCT03975673
UNKNOWN
NA
Minimal Invasive Versus Traditional Transgluteal Approach in Total Hip Arthroplasty: a Comparative Gait Analysis
NCT00831363
COMPLETED
Study of Total Hip Arthroplasty Using Radlink Surgical Positioning Software
NCT02536573
COMPLETED
NA
Clinical Study and Economic Analysis of an Intraoperative Navigation System for Total Hip Arthroplasty
NCT05416463
UNKNOWN
NA
Total Hip Arthroplasty: Fluoroscopy vs Freehand
NCT05653687
RECRUITING
NA
Digital Sizing for Orthopaedic Hip Implants
NCT00665210
UNKNOWN
Anterior Capsulectomy vs. Repair in Direct Anterior THA
NCT01621932
COMPLETED
NA
Anterior vs Posterior Approach in THA
NCT03673514
COMPLETED
NA
The Impact of Total Knee Arthroplasty Surgical Technique on Coronal Plane Motion and PatelloFemoral Articulation
NCT01855906
WITHDRAWN
NA
Outcomes Following Anterior Approach to Total Hip Arthroplasty
NCT01353885
TERMINATED
Anterior Minimal Invasive Surgery Versus Antero-lateral Approach in Hip Joint Hemiarthroplasty
NCT05255198
COMPLETED
Unrestricted Rehabilitation Following Primary THA
NCT02079467
UNKNOWN
NA
The Postural Control in Patients After Total Hip Replacement
NCT03218267
COMPLETED
NA
Examining Effects of Spinal Fusion on Outcomes Following Total Hip Replacement
NCT03240484
UNKNOWN
PT vs no PT Following THA
NCT02687945
COMPLETED
NA
A Short Metaphyseal Fitting Total Hip Arthroplasty in Young and Elderly Patients
NCT01345097
COMPLETED
PHASE4
Motion Analysis of EMP Knee Versus Posterior Stabilized Knee Arthroplasty for Osteoarthritis
NCT00967161
COMPLETED
NA
Effectiveness of Total Hip Arthroplasty for Patients With Osteoarthritis, a Target Trial Emulation Study
NCT06263569
COMPLETED
Unilateral vs Bilateral Total Hip Arthroplasty
NCT00764335
COMPLETED
Ultra-Short Anatomic and Conventional Cementless Stems Cementless Stems in Patients Younger Than Fifty-Five Years Old
NCT02338596
COMPLETED
PHASE4
Feasibility of Outpatient Total Knee Arthroplasty
NCT01186211
COMPLETED