Observational Study to Evaluate Long-Term Outcome in Hip... | NCT02230826

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Dec 2034Estimated

Completion Date

Dec 2044Estimated

First Submitted Date

Aug 29, 2014

First Submission Date that Met QC Criteria

Sep 2, 2014

First Posted Date

Sep 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2026

Last Update Posted Date

Mar 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This long-term outcomes study is designed to collect safety and efficacy data on designated, commercially available, hip arthroplasty products.

Detailed Description

Outcome data collected from this study will be used for Post Market Surveillance (PMS) and Clinical Evaluations on Corin hip devices and will support peer-reviewed publications on products performance and safety at long term follow-up.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,500Estimated

Label	Type	Description	Intervention Names
Patients with Hip arthroplasty		Patients with Hip implants.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of long-term outcome after hip arthroplasty with Corin implants.	Implants revision rate at 10-year FU hip arthroplasty	At 10 years

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of long-term outcome after hip arthroplasty with Corin implants at 15 and 20-year FU.	Implants revision rate at 15- and 20-year FU.	at 15- and 20-year
Evaluation of clinical performance of Corin hip implants

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Man or woman >18 years
Subjects with indication of arthroplasty surgery with Corin hip devices which are under assessment as part of this PMCF study
Subjects who agreed for study participation.

Exclusion Criteria:

Subjects with existing tumour and/or particularly high surgical risk-
Subjects with anaesthetic risk class IV or higher
Subjects under guardianship and/or unable to follow procedures or matters related to the study (examples: Illiterate, recent psychotic or mania disorders and / or inability to comply with usual follow-up visits.)
Contraindications for arthroplasty with a Corin hip devices as per product IFU

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Cohort of patients with a partial or total hip replacement (Corin implants)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vanessa Grimaud	Contact			vanessa.grimaud@coringroup.com

Overall Officials

Name	Affiliation	Role
Goulven Rochcongar, MD	University Hospital, Caen	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Bordeaux - Groupe Hospitalier Pellegrin	Active, not recruiting	Bordeaux		33000	France

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D009362	Neoplasm Metastasis
D005271	Femur Head Necrosis

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010020	Osteonecrosis
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D009336	Necrosis