An observational study in Osteolysis, Arthroplasty Complications and Instability of Prosthetic Joint, sponsored by Aesculap AG. Active, not recruiting at 4 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Aesculap AG (part of B. Braun) · Observational
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.
22 studies on the registry are indexed under Osteolysis; 4 are open to participants now.
Browse Osteolysis studies →Aesculap AG is the lead sponsor of 105 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients having acute disorders of the hip, requiring primary or revision surgery, which cannot be treated by other therapies:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
Device: Plasmafit® Revision Structan®
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
Harris Hip Score (Functional results of the operated hip) over time
The functional results of the operated hip will be assessed with the Harris Hip Score (HHS) and evaluated over time
Time frame: up to five years postoperatively
Survival of the implant
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.
Time frame: up to five years postoperatively
Quality of Life over time
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).
Time frame: up to five years postoperatively
Radiological Assessment: Osseointegration of the cup over time
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.
Time frame: at 3 months, 24 months, 5 years follow-up
Radiological assessment: Radiographic loosening of the cup over time
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.
Time frame: at 3 months, 24 months, 5 years follow-up
Technical problems during surgery
Technical problems with instruments, implants or containers, instrument related issues
Time frame: Intraoperative
Impingement
The incidence of impingement during intraoperative mobilization is documented;
Time frame: Intraoperative
General handling of instruments / containers
Complaints or problems with the handling of instruments, implants or containers, instrument related issues
Time frame: Intraoperative
Complications
All complications in the postoperative course are recorded
Time frame: up to 5 years postoperatively
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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