Post Market Clinical Follow-Up of Plasmafit® Cup

NCT ID: NCT02019849

Last Updated: 2025-11-17

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

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-18

Study Completion Date

2024-09-27

Brief Summary

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Twelve months follow-up of implant survival and clinical and radiological follow-up of Plasmafit® Cup.

Detailed Description

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Conditions

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Total Hip Arthroplasty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Plasmafit® Total Hip Arthroplasty

Plasmafit® Total Hip Arthroplasty

Intervention Type DEVICE

Interventions

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Plasmafit® Total Hip Arthroplasty

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Minimum age 18 years
* Indication for cementless total hip arthroplasty
* Patient consent for study participation
* Physical and mental willingness to participate at clinical and radiological follow-up

Exclusion Criteria

* Patient not available for follow-up
* Increased anesthetics risks according to the "American Society of Anesthesiology": ASA IV
* Tumor
* Alcohol or drug abuse
* Permanent cortisone therapy
* Clinically relevant infection
* Pregnancy or planned pregnancy
* Prior interventions like osteotomy, fracture treatment or prior THA at the concerned hip
* Acute fracture at the concerned hip
* Patients needing a cemented hip arthroplasty
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vulpius-Klinik Bad Rappenau

Bad Rappenau, , Germany

Site Status

Diakonie-Klinikum Stuttgart

Stuttgart, , Germany

Site Status

Countries

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Germany

Other Identifiers

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AAG-O-H-1213

Identifier Type: -

Identifier Source: org_study_id

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