Observational Ambispective Study on HYPE Cups Associated With HIPER Liner

Hip Arthropathy Clinical Trial

Official title:

Observational Ambispective Study on HYPE Cups Associated With HIPER Liner

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06465940
• Other study ID #: 2020-05
• Status: Completed
• Start date: July 3, 2020
• Est. completion date: July 7, 2020

Study information

• Verified date: June 2024
• Source: Societe dEtude, de Recherche et de Fabrication
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study intend to collect data on total hip arthroplasty performed with HYPE cups used with conventional polyethylene liner (HIPER).

Medical Device Regulation 2017/745 regulation required proper clinical data to support claims. This study is therefore intended to provide data on HYPE devices to comply with Medical Device Regulation2047/745 regulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 7, 2020
• Est. primary completion date: July 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient was an adult at surgery,

• Patient implanted with HYPE® acetabular cup and HIPER liner,

• Patient was followed-up at least once on retrospective part of the study,

• Patient's current social security affiliation is valid.

Exclusion Criteria:

• Patient refuses the use of his/her personal data,

• Patient is unable to follow surgeon's instruction or unavailable for follow-up,

• Patient with contraindication to x-rays,

• Patient not implanted with HYPE® acetabular cup and HIPER liner.

Related Conditions & MeSH terms

• Hip Arthropathy
• Joint Diseases

Intervention

Device:
• Total hip arthroplasty
Replacement of hip joint

Locations

Country	Name	City	State
France	Centre Hospitalier de la Côte Basque	Bayonne

Sponsors (1)

Lead Sponsor	Collaborator
Societe dEtude, de Recherche et de Fabrication

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional score	The information will be collected through questionnaires to compare preoperatively situation to last follow-up situation	per operative period to at least 2 year
Secondary	Patient satisfaction	The information will be collected from patient through questionnaires to compare preoperatively situation to last follow-up situation	per operative period to at least 2 year
Secondary	Safety adverse event	Type and occurence of adverse events	per operative period to at least 2 year
Secondary	Survival rate	Kaplan-Meier survival rates of cups and liners	per operative period to at least 2 year