Prospective and Obsevational Study of Total Hip Prothesis: HYPE Stem

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-05

Study Completion Date

2031-01-20

Brief Summary

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The purpose of this study is to validate the performance and the safety of the HYPE (SERF) prothesis in compliance with the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 guide ( guideline for post-market follow-up), which provides for the implementation of a systematic procedure for the follow-up of clinical data in order to verify the performance claimed for medical devices .

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Detailed Description

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Conditions

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Hip Arthropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Man or women
* Degenerative or inflammatory hip pathology requiring a total hip replacement
* Primary or secondary osteoarthritis
* Advanced joint destruction resulting from rhumatoid arthritis or traumatic arthritis
* Fracture or avascular necrosis
* Sub-capital fracture and displaced transcervical as well as for bone defects stages I to IIb of PAPROSKY
* Traumatic joint destruction
* Following previous intervention, provided that the new device does not interfere with the material in place (osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty, total arthroplasty

Exclusion Criteria

* People with diminished mental faculties
* Known current pregnancy
* Breast-feeding
* Neurological disorders or other pathologies that may influence locomotion
* Septic antecedent on hip to operate
* Patient requiring a bone graft

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No