Biomechanical Reconstruction of Three Different Hip Stem Designs in Hip Dysplasia Using a 3D CT-based Planning Software (CTdevice)
6 september 2021 bijgewerkt door: Istituto Ortopedico Rizzoli
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
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.
Studie Overzicht
Gedetailleerde beschrijving
Pre-operative planning in hip arthroplasty with dedicated software is a useful guide to provide a better reconstruction of the biomechanical parameters of the replaced hip and to optimize the choice of component, improving the geometric understanding of the hip anatomy and the interaction between the native morphological structure and the prosthetic component.
The use of a 3D CT-based software for pre-operative planning may provide a better knowledge of the hip anatomy, simulating the biomechanical parameters more closely than a 2D X-ray-based software. In addition, it is the only way to anticipate the correct interaction between the prosthetic components, or the combined anteversion, a key factor in preventing implant instability.
Severe hip deformities, like developmental hip dysplasia, may not be adequately reconstructed by every implant and 3D pre-operative CT may increase the three-dimensional anatomical knowledge of the hip, improving the choice of the correct implant and possibly reducing the possible consequences of intra and post-operative complications.
Therefore, the purpose of this study is to pre-operatively plan, in a random series of 200 native pelvis and thigh CT scans performed in patients with hip dysplasia, 3 different types of hip stem designs using the 3D Hip-Op software, with the aim of analyzing, on the CT simulations, the percentage of adequate reconstruction of the optimal biomechanical parameters (combined anteversion between 25°-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%). The percentage of every stem design providing the optimal reconstruction in dysplastic hips (all the 5 parameters matched) will be assessed. The single parameters, especially the combined anteversion, the offset restoration and the leg lengthening, will be assessed for every simulation.
Studietype
Observationeel
Inschrijving (Werkelijk)
150
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Bologna, Italië, 40136
- Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
A random population of 200 CT scans (from the fourth lumbar vertebra to the tibial plateaus) involving adult patients with developmental hip dysplasia.
Beschrijving
Inclusion Criteria:
- definition of developmental hip dysplasia according to Wiberg (center edge angle <20°)
- pre-operative CT scan extended from the fourth lumbar vertebra to the tibial plateaus
Exclusion Criteria:
- other types of hip pathologies
- inadequate Ct scans
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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CLS stem
CLS Zimmer stem implantation (single wedge, tapered stem) using the 3D CT based software for surgical pre-operative planning
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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.
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Wagner cone stem
Wagner cone Zimmer stem implantation (conical tapered stem) using the 3D CT based software for surgical pre-operative planning
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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.
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Aptafix stem
Aptafix Ortho stem implantation (anatomical stem) using the 3D CT based software for surgical pre-operative planning
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Correct Reconstruction CLS
Tijdsspanne: Day 0
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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
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Day 0
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Correct Reconstruction Wagner Cone
Tijdsspanne: Day 0
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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
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Day 0
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Correct Reconstruction Aptafix
Tijdsspanne: Day 0
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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
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Day 0
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Combined Anteversion CLS
Tijdsspanne: Day 0
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Percentage of hips with adequate combined anteversion according to Dorr (25-50°) and Widmer (<37°) using CLS stems.
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 is the worst
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Day 0
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Combined Anteversion Wagner Cone
Tijdsspanne: Day 0
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Percentage of hips with adequate combined anteversion according to Dorr (25-50°) and Widmer (<37°) using CLS stems.
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 is the worst
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Day 0
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Combined Anteversion Aptafix
Tijdsspanne: Day 0
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Percentage of hips with adequate combined anteversion according to Dorr (25-50°) and Widmer (<37°) using CLS stems.
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 is the worst
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Day 0
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Offset CLS
Tijdsspanne: Day 0
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Percentage of hips with acetabular+femoral offset not inferior to 12% of the native value using CLS stems.
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 is the worst
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Day 0
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Offset Wagner Cone
Tijdsspanne: Day 0
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Percentage of hips with acetabular+femoral offset not inferior to 12% of the native value using CLS stems.
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 is the worst
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Day 0
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Offset Aptafix
Tijdsspanne: Day 0
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Percentage of hips with acetabular+femoral offset not inferior to 12% of the native value using CLS stems.
Minimum-maximum values (as percentage %): 0-100.
100 is the best result, 0 is the worst
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Day 0
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Leg Lengthening CLS
Tijdsspanne: Day 0
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Percentage of hips with leg lengthening not superior to 3 cm using CLS stems.
Minimum-maximum values (as percentages %): 0-100.
100 is the best result, 0 is the worst
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Day 0
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Leg Lengthening Wagner Cone
Tijdsspanne: Day 0
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Percentage of hips with leg lengthening not superior to 3 cm using CLS stems.
Minimum-maximum values (as percentages %): 0-100.
100 is the best result, 0 is the worst
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Day 0
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Leg Lengthening Aptafix
Tijdsspanne: Day 0
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Percentage of hips with leg lengthening not superior to 3 cm using CLS stems.
Minimum-maximum values (as percentages %): 0-100.
100 is the best result, 0 is the worst
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Day 0
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Francesco Traina, Professor, IRCCS Istituto Ortopedico Rizzoli
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
10 mei 2021
Primaire voltooiing (Werkelijk)
10 juli 2021
Studie voltooiing (Werkelijk)
10 juli 2021
Studieregistratiedata
Eerst ingediend
21 mei 2021
Eerst ingediend dat voldeed aan de QC-criteria
24 mei 2021
Eerst geplaatst (Werkelijk)
27 mei 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 september 2021
Laatste update ingediend die voldeed aan QC-criteria
6 september 2021
Laatst geverifieerd
1 februari 2021
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 29/2021/Oss/IOR
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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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