NCT02019849

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 24, 2013

Completed
10.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2024

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

December 4, 2013

Last Update Submit

November 14, 2025

Conditions

Total Hip Arthroplasty

Keywords

THA, Plasmafit®

Outcome Measures

Primary Outcomes (1)

  • 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 (5)

  • Osteolysis

    3 months, 12 months, 5 years, 10 years

  • Ossifications

    3 months, 12 months, 5 years, 10 years

  • Implant Position

    3 months, 12 months, 5 years, 10 years

  • Migration of Plasmafit®

    3 months, 12 months, 5 years, 10 years

  • Clinical Outcome

    3 months, 12 months, 5 years, 10 years

Study Arms (1)

Plasmafit® Total Hip Arthroplasty

Device: Plasmafit® Total Hip Arthroplasty

Interventions

Plasmafit® Total Hip ArthroplastyDEVICE
Plasmafit® Total Hip Arthroplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Specialist Clinical Centre

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vulpius-Klinik Bad Rappenau

Bad Rappenau, Germany

Location

Diakonie-Klinikum Stuttgart

Stuttgart, Germany

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2013

First Posted

December 24, 2013

Study Start

June 18, 2012

Primary Completion

October 4, 2012

Study Completion

September 27, 2024

Last Updated

November 17, 2025

Record last verified: 2025-11

Locations

DE(2)