Plasmafit® Revision Structan® Hip Endoprosthesis Cup

N/AActive Not RecruitingNCT04255966

Aesculap AG60 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

Plasmafit® Revision Structan®DEVICE

Plasmafit® Revision Structan® Hip Endoprosthesis Cup

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Orthopädische Klinik König-Ludwig-Haus

Würzburg, Bavaria, Germany

Herzogin Elisabeth Hospital

Braunschweig, Niedersachse, Germany

Gemeinschaftskrankenhaus Bonn

Bonn, North Rhine-Westphalia, Germany

Universitätsklinikum des Saarlandes

Homburg, Saarland, Germany

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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