Plasmafit® Revision Structan® Hip Endoprosthesis Cup

April 30, 2026 updated by: Aesculap AG

Prospective, Multi-centric, Comparative, Long-term Clinical Follow-Up Study for the Evidence of Safety and Performance Indicators of the Plasmafit® Revision Structan® Hip Endoprosthesis Cup

The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Würzburg, Bavaria, Germany, 97074
        • Orthopädische Klinik König-Ludwig-Haus
    • Niedersachse
      • Braunschweig, Niedersachse, Germany, 38124
        • Herzogin Elisabeth Hospital
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany, 53113
        • Gemeinschaftskrankenhaus Bonn
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • Universitätsklinikum des Saarlandes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients having acute disorders of the hip, requiring primary or revision surgery, which cannot be treated by other therapies:

  • Degenerative osteoarthritis
  • Rheumatic arthritis
  • Fractures of the joint
  • Femoral head necrosis
  • Revision surgery where a sufficient intraoperative press-fit can be achieved

Description

Inclusion Criteria

  • Indication for the cementless Plasmafit® Revision Structan® Hip Endoprosthesis Cup (primary and revision cases, with bone conditions typically demanding a press-fit revision cup)
  • Written informed consent
  • Cases where a press-fit cup fixation is possible

Exclusion Criteria

  • Patients < 18 years
  • Pregnant patients
  • Patients not able to comply with the study demands, i.e. follow-up visits (mentally or physically)
  • Patient has an infection in the hip joint region

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Plasmafit® Revision Structan®
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
Device: Plasmafit® Revision Structan®
Plasmafit® Revision Structan® Hip Endoprosthesis Cup

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harris Hip Score (Functional results of the operated hip) over time
Time Frame: up to five years postoperatively
The functional results of the operated hip will be assessed with the Harris Hip Score (HHS) and evaluated over time
up to five years postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival of the implant
Time Frame: up to five years postoperatively

Any removal or exchange of the acetabular cup or the polyethylene inlay is defined as revision.

A removal of the stem is not evaluated as acetabular revision but will be documented and evaluated as part of postoperative complications.

The revision-free survival will be assessed using the Kaplan-Meier method.
up to five years postoperatively
Quality of Life over time
Time Frame: up to five years postoperatively
EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which can take one of three responses reflecting severity (no problems/some or moderate problems/extreme problems).
up to five years postoperatively
Radiological Assessment: Osseointegration of the cup over time
Time Frame: at 3 months, 24 months, 5 years follow-up
The acetabular component in AP view is divided into the three regions I-III as defined by DeLee-Charnley. All three regions will be assessed for osteolysis the implant, to allow an estimation of the osseous integration and stability of the implant.
at 3 months, 24 months, 5 years follow-up
Radiological assessment: Radiographic loosening of the cup over time
Time Frame: at 3 months, 24 months, 5 years follow-up
The acetabular component in AP view is divided into the three regions I-III as defined by DeLee-Charnley. All three regions will be assessed for and radiolucent lines around the implant, to allow an estimation of the osseous integration and stability of the implant.
at 3 months, 24 months, 5 years follow-up
Technical problems during surgery
Time Frame: Intraoperative
Technical problems with instruments, implants or containers, instrument related issues
Intraoperative
Impingement
Time Frame: Intraoperative
The incidence of impingement during intraoperative mobilization is documented;
Intraoperative
General handling of instruments / containers
Time Frame: Intraoperative
Complaints or problems with the handling of instruments, implants or containers, instrument related issues
Intraoperative
Complications
Time Frame: up to 5 years postoperatively
All complications in the postoperative course are recorded
up to 5 years postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Investigators

  • Principal Investigator: Stefan Landgraeber, Prof. Dr., University Hospital, Saarland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2021

Primary Completion (Actual)

August 16, 2023

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

January 30, 2020

First Submitted That Met QC Criteria

February 3, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-H-1821

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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