Biomechanical Reconstruction of Three Different Hip Stem Designs in Hip Dysplasia Using a 3D CT-based Planning Software (CTdevice)
6. september 2021 oppdatert av: 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.
Studieoversikt
Detaljert beskrivelse
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
Observasjonsmessig
Registrering (Faktiske)
150
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Bologna, Italia, 40136
- Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
A random population of 200 CT scans (from the fourth lumbar vertebra to the tibial plateaus) involving adult patients with developmental hip dysplasia.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Correct Reconstruction CLS
Tidsramme: Day 0
|
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
|
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Correct Reconstruction Wagner Cone
Tidsramme: 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
|
Day 0
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Correct Reconstruction Aptafix
Tidsramme: Day 0
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Combined Anteversion CLS
Tidsramme: 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
|
Day 0
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Combined Anteversion Wagner Cone
Tidsramme: Day 0
|
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
|
Day 0
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Combined Anteversion Aptafix
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Day 0
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Offset Aptafix
Tidsramme: 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
|
Day 0
|
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Leg Lengthening CLS
Tidsramme: 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
|
Day 0
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Leg Lengthening Wagner Cone
Tidsramme: 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
|
Day 0
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Leg Lengthening Aptafix
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Francesco Traina, Professor, IRCCS Istituto Ortopedico Rizzoli
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
10. mai 2021
Primær fullføring (Faktiske)
10. juli 2021
Studiet fullført (Faktiske)
10. juli 2021
Datoer for studieregistrering
Først innsendt
21. mai 2021
Først innsendt som oppfylte QC-kriteriene
24. mai 2021
Først lagt ut (Faktiske)
27. mai 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. september 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. september 2021
Sist bekreftet
1. februar 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 29/2021/Oss/IOR
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