Post Market Clinical Follow-Up of Plasmafit® Cup | NCT02019849

Studies
Post Market Clinical Follow-Up of Plasmafit® Cup

NCT02019849

Sponsor

Aesculap AG

Status

Completed

Last Update Posted

Nov 17, 2025Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Total Hip Arthroplasty

Interventions

Plasmafit® Total Hip Arthroplasty

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 18, 2012Actual

Primary Completion Date

Oct 4, 2012Actual

Completion Date

Sep 27, 2024Actual

First Submitted Date

Dec 4, 2013

First Submission Date that Met QC Criteria

Dec 18, 2013

First Posted Date

Dec 24, 2013Estimated

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

Nov 14, 2025

Last Update Posted Date

Nov 17, 2025Actual

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

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Plasmafit® Total Hip Arthroplasty			Device: Plasmafit® Total Hip Arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plasmafit® Total Hip Arthroplasty	Device		Plasmafit® Total Hip Arthroplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Implant Survival Rates	Implant survival is analysed at follow-up examinations at 3 months, 12 months, 5 years and 10 years	10 years

Secondary Outcomes

Measure	Description	Time Frame
Osteolysis	Radiological Outcome	3 months, 12 months, 5 years, 10 years
Ossifications	Radiological Outcome	3 months, 12 months, 5 years, 10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

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

Specialist Clinical Centre

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vulpius-Klinik Bad Rappenau		Bad Rappenau			Germany
Diakonie-Klinikum Stuttgart