Plasmafit® Revision Structan® Hip Endoprosthesis Cup

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Osteolysis, Arthroplasty Complications, Instability of Prosthetic Joint, Degenerative Osteoarthritis, Rheumatic Arthritis, Fractures, Hip, Femoral Head Avascular Necrosis, Prosthesis Failure

Intervention / Treatment
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* Device: Plasmafit® Revision Structan®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Plasmafit® Revision Structan®<br>Plasmafit® Revision Structan® Hip Endoprosthesis Cup | Device: Plasmafit® Revision Structan®<br>* Plasmafit® Revision Structan® Hip Endoprosthesis Cup<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to five years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | 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. | at 3 months, 24 months, 5 years follow-up | 
| Technical problems during surgery | Technical problems with instruments, implants or containers, instrument related issues | Intraoperative | 
| Impingement | The incidence of impingement during intraoperative mobilization is documented; | Intraoperative | 
| General handling of instruments / containers | Complaints or problems with the handling of instruments, implants or containers, instrument related issues | Intraoperative | 
| Complications | All complications in the postoperative course are recorded | up to 5 years postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Revision of the acetabular implant, orthopaedic surgery, osteolysis, wear particles, cup loosening, malpositioned cup