Biomechanical Reconstruction of Three Different Hip Stem Designs in Hip Dysplasia Using a 3D CT-based Planning Software

NCT04904640 | Completed Results DMC

• 1 other identifier: 29/2021/Oss/IOR
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dysplasia; Hip

Keywords

Hip arthroplasty; Hip stem; Pre-operative planning; Combined anteversion; Offset; Developmental dysplasia of the hip

Outcome Measures

Primary Outcomes (3)

• 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

  Day 0

Secondary Outcomes (9)

• 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

Study Arms (3)

CLS stem

CLS Zimmer stem implantation (single wedge, tapered stem) using the 3D CT based software for surgical pre-operative planning

Device: Hip stem

Wagner cone stem

Wagner cone Zimmer stem implantation (conical tapered stem) using the 3D CT based software for surgical pre-operative planning

Device: Hip stem

Aptafix stem

Aptafix Ortho stem implantation (anatomical stem) using the 3D CT based software for surgical pre-operative planning

Device: Hip stem

Interventions

Hip stem DEVICE

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.

Aptafix stem; CLS stem; Wagner cone stem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A random population of 200 CT scans (from the fourth lumbar vertebra to the tibial plateaus) involving adult patients with developmental hip dysplasia.

You may qualify if:

• 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

You may not qualify if:

• other types of hip pathologies
• inadequate Ct scans

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy

Bologna, 40136, Italy

Location

Related Publications (4)

• 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.

  PMID: 28110848 BACKGROUND

• 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.

  PMID: 16129740 BACKGROUND

• 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.

  PMID: 22569720 BACKGROUND

• 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.

  PMID: 30612885 BACKGROUND

MeSH Terms

Conditions

Hip Dislocation; Developmental Dysplasia of the Hip

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Francesco Castagnini, MD
• Organization: IRCCS Istituto Ortopedico Rizzoli

francesco.castagnini@ior.it

+390516366418

Study Officials

• Francesco Traina, Professor

  IRCCS Istituto Ortopedico Rizzoli

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 27, 2021
• Study Start: May 10, 2021
• Primary Completion: July 10, 2021
• Study Completion: July 10, 2021
• Last Updated: September 9, 2021
• Results First Posted: September 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)