CTdevice
Evaluation of the Reconstruction of Biomechanical Parameters Provided by Three Different Hip Stem Designs in Developmental Hip Dysplasia Using a 3D CT-based Software for Surgical Planning
Sponsor study identifier
observational
150
1 country
1
Study Start
May 10, 2021
Actual (reported)Primary Completion
July 10, 2021
Actual (reported)Study Completion
July 10, 2021
Actual (reported)A random population of 200 CT scans of pelvis and thigh in an adult population affected by hip dysplasia will be selected. The aim of this study is to evaluate the biomechanical reconstruction of the hip anatomy provided by three different hip stem designs in dysplastic cases, using a 3D CT based software for pre-operative planning.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 10, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 10, 2021
Actual (reported)May 21, 2021
Actual (reported)May 27, 2021
Actual (reported)July 10, 2021
Actual (reported)July 10, 2021
Actual (reported)September 9, 2021
Actual (reported)Correct Reconstruction CLS
Percentage of hips correctly reconstructed using CLS stem: the correctly reconstructed hip should have combined anteversion between 25° and 50°, global offset not inferior to 12% of the native offset, leg lengthening not superior to 3 cm, sagittal and coronal tilt not superior to +/-5°, canal filling not inferior to 80% (all the 5 parameters should be present at the same time). Minimum-maximum values (as percentage %): 0-100. 100 is the best result, 0 the worst
Day 0
Correct Reconstruction Wagner Cone
Percentage of hips correctly reconstructed using CLS stem: the correctly reconstructed hip should have combined anteversion between 25° and 50°, global offset not inferior to 12% of the native offset, leg lengthening not superior to 3 cm, sagittal and coronal tilt not superior to +/-5°, canal filling not inferior to 80% (all the 5 parameters should be present at the same time). Minimum-maximum values (as percentage %): 0-100. 100 is the best result, 0 the worst
Day 0
Correct Reconstruction Aptafix
Percentage of hips correctly reconstructed using CLS stem: the correctly reconstructed hip should have combined anteversion between 25° and 50°, global offset not inferior to 12% of the native offset, leg lengthening not superior to 3 cm, sagittal and coronal tilt not superior to +/-5°, canal filling not inferior to 80% (all the 5 parameters should be present at the same time). Minimum-maximum values (as percentage %): 0-100. 100 is the best result, 0 the worst
Combined Anteversion CLS
Day 0
Combined Anteversion Wagner Cone
Day 0
Combined Anteversion Aptafix
Day 0
Offset CLS
Day 0
Offset Wagner Cone
Day 0
CLS Zimmer stem implantation (single wedge, tapered stem) using the 3D CT based software for surgical pre-operative planning
Wagner cone Zimmer stem implantation (conical tapered stem) using the 3D CT based software for surgical pre-operative planning
Aptafix Ortho stem implantation (anatomical stem) using the 3D CT based software for surgical pre-operative planning
In every hip (with appropriate CT scan), 3 different stem designs will be positioned using a 3D Ct based software for surgical pre-operative planning.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
A random population of 200 CT scans (from the fourth lumbar vertebra to the tibial plateaus) involving adult patients with developmental hip dysplasia.
Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
Bologna, 40136, Italy
Taniguchi N, Jinno T, Koga D, Hagino T, Okawa A, Haro H. Cementless Hip Stem Anteversion in the Dysplastic Hip: A Comparison of Tapered Wedge vs Metaphyseal Filling. J Arthroplasty. 2017 May;32(5):1547-1552. doi: 10.1016/j.arth.2016.12.020. Epub 2016 Dec 22.
Argenson JN, Ryembault E, Flecher X, Brassart N, Parratte S, Aubaniac JM. Three-dimensional anatomy of the hip in osteoarthritis after developmental dysplasia. J Bone Joint Surg Br. 2005 Sep;87(9):1192-6. doi: 10.1302/0301-620X.87B9.15928.
Francesco Traina, Professor
IRCCS Istituto Ortopedico Rizzoli
150 participants (actual enrollment reported by the registry).
First Submitted
May 21, 2021
First Posted
May 27, 2021
Study Start
May 10, 2021
Actual (reported)Primary Completion
Day 0
Contact the study team to confirm eligibility.
Sugano N, Takao M, Sakai T, Nishii T, Miki H. Does CT-based navigation improve the long-term survival in ceramic-on-ceramic THA? Clin Orthop Relat Res. 2012 Nov;470(11):3054-9. doi: 10.1007/s11999-012-2378-4.
Castagnini F, Valente G, Crimi G, Taddei F, Bordini B, Stea S, Toni A. Component positioning and ceramic damage in cementless ceramic-on-ceramic total hip arthroplasty. J Orthop Sci. 2019 Jul;24(4):643-651. doi: 10.1016/j.jos.2018.12.011. Epub 2019 Jan 4.
July 10, 2021
Actual (reported)Study Completion
July 10, 2021
Actual (reported)Last Updated
September 9, 2021
Results First Posted
September 9, 2021
Record last verified: 2021-02
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Source: ClinicalTrials.gov.
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