Observational Ambispective Study on HYPE Cups Associated With HIPER Liner

NCT06465940 | Completed

• 1 other identifier: 2020-05
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hip Arthropathy

Keywords

Total hip arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient satisfaction

  per operative period to at least 2 year

• Safety adverse event

  per operative period to at least 2 year

• Survival rate

  per operative period to at least 2 year

Interventions

Total hip arthroplasty DEVICE

Replacement of hip joint

Eligibility Criteria

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

Study Population

Patient implanted in the selected investigational site with a HYPE® acetabular cup and HIPER liner between 2016 and 2018 were identified. The following selection criteria were used.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Societe dEtude, de Recherche et de Fabrication: lead

Study Sites (1)

Centre Hospitalier de la Côte Basque

Bayonne, 64109, France

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 20, 2024
• Study Start: July 3, 2020
• Primary Completion: July 7, 2020
• Study Completion: July 7, 2020
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

FR (1)