Radiographic Changes and Clinical Implications of Implantation of Shortened Uncemented Femoral Stems in THA

Hip Osteoarthritis Clinical Trial

— THA  

Official title:

Study of Radiographic Changes and Their Clinical Implications at 2 Years of Implantation of Shortened Uncemented Femoral Stems in Total Hip Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05666284
• Other study ID #: 8720
• Status: Recruiting
• Start date: October 11, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: University Hospital, Strasbourg, France
• Contact: François BONNOMET, MD, PhD
• Phone: 33 3 68 76 52 82
• Email: Francois.bonnomet[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The hip prosthesis market is constantly growing with the number of prostheses reaching 949,000 in 2019. Along with this, there is also an increase in interest in short stems also called shortened stems. Thus on Pubmed, in 5 years, 171 publications have been listed.

Thus, it seems interesting to study and analyze the performance of the shortened stem used in the Department of Orthopedic Surgery and Traumatology of the University Hospitals of Strasbourg and to compare them with the results of the literature.

Description:

The objective of this study is to observe the appearance of shortened stem radiological abnormalities at least 2 years postoperatively.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: December 31, 2023
• Est. primary completion date: December 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Male or female (age =18 years old)

• Subject operated for first-line THA for an indication of centric hip osteoarthritis (including minor dysplasia and coxa profunda) and aseptic osteonecrosis of the femoral head

• Subject who received a THA between January 2015 and December 2019

• Subject who received an uncemented shortened SCC or SCLA femoral stem

• Radiological data available: pre-operative, immediate post-operative and post-operative at a minimum of 2 years (=24 months)

• Subject not objecting to the reuse of their data for scientific research purposes.

Exclusion criteria:

• Subject having expressed its opposition to the reuse of its data for scientific research purposes.

• Patient operated for inflammatory pathology or major dysplasia, recovery

• Associated fractures or sequelae of fractures

• Patient having presented intraoperative or early complications such as infections, intraoperative fracture, dislocation of the hip following the installation of the THA

• Revision of hip arthroplasty during the study follow-up period for a cause not studied in the study.

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip
• Osteonecrosis

Locations

Country	Name	City	State
France	Service de Chirurgie Orthopédique et de Traumatologie du Membre Inférieur - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone changes around the femoral implant at 2 years on hip radiographs.		2 years postoperatively