Plasmafit® Revision Structan® Hip Endoprosthesis Cup

Arthroplasty Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04255966
• Other study ID #: AAG-H-O-1821
• Status: Active, not recruiting
• Start date: April 12, 2021
• Est. completion date: June 2027

Study information

• Verified date: February 2024
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 2027
• Est. primary completion date: August 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Plasmafit® Revision Structan®
Plasmafit® Revision Structan® Hip Endoprosthesis Cup

Locations

Country	Name	City	State
Germany	Gemeinschaftskrankenhaus Bonn	Bonn	Nordrhein-Westfalen
Germany	Herzogin Elisabeth Hospital	Braunschweig	Niedersachse
Germany	Universitätsklinikum des Saarlandes	Homburg	Saarland
Germany	Orthopädische Klinik König-Ludwig-Haus	Würzburg	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Technical problems during surgery	Technical problems with instruments, implants or containers, instrument related issues	Intraoperative
Secondary	Impingement	The incidence of impingement during intraoperative mobilization is documented;	Intraoperative
Secondary	General handling of instruments / containers	Complaints or problems with the handling of instruments, implants or containers, instrument related issues	Intraoperative
Secondary	Complications	All complications in the postoperative course are recorded	up to 5 years postoperatively