Plasmafit® Revision Structan® Hip Endoprosthesis Cup

Active, not recruiting

• Conditions: Instability of Prosthetic Joint; Prosthesis Failure; Fractures, Hip; Osteolysis; Femoral Head Avascular Necrosis; Arthroplasty Complications; Degenerative Osteoarthritis; Rheumatic Arthritis
• Interventions: Device: Plasmafit® Revision Structan®

• Registration Number: NCT04255966
• Lead Sponsor: Aesculap AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-02-03
• Study First Posted: 2020-02-05
• Study Start: 2021-04-12
• Primary Completion: 2023-08-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Plasmafit® Revision Structan®	Plasmafit® Revision Structan®	Plasmafit® Revision Structan® Hip Endoprosthesis Cup

Primary Outcome Measures

Name	Time	Method
Harris Hip Score (Functional results of the operated hip) over time	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

Secondary Outcome Measures

Name	Time	Method
Survival of the implant	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.
Radiological Assessment: Osseointegration of the cup over time	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.
Impingement	Intraoperative	The incidence of impingement during intraoperative mobilization is documented;
Complications	up to 5 years postoperatively	All complications in the postoperative course are recorded
Technical problems during surgery	Intraoperative	Technical problems with instruments, implants or containers, instrument related issues
Quality of Life over time	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).
Radiological assessment: Radiographic loosening of the cup over time	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.
General handling of instruments / containers	Intraoperative	Complaints or problems with the handling of instruments, implants or containers, instrument related issues

Trial Locations

Locations (4)

Universitätsklinikum des Saarlandes; 🇩🇪 Homburg, Saarland, Germany

Orthopädische Klinik König-Ludwig-Haus; 🇩🇪 Würzburg, Bayern, Germany

Herzogin Elisabeth Hospital; 🇩🇪 Braunschweig, Niedersachse, Germany

Gemeinschaftskrankenhaus Bonn; 🇩🇪 Bonn, Nordrhein-Westfalen, Germany