Arthroplasty Complications, Degenerative Osteoarthritis, Femoral Head Avascular Necrosis, Fractures, Hip, Instability of Prosthetic Joint, Osteolysis, Prosthesis Failure, Rheumatic Arthritis
Conditions
Keywords
Revision of the acetabular implant, orthopaedic surgery, osteolysis, wear particles, cup loosening, malpositioned cup
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.
Interventions
DEVICEPlasmafit® Revision Structan®
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
Sponsors
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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: 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. |
| 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. |
| Technical problems during surgery | Intraoperative | Technical problems with instruments, implants or containers, instrument related issues |
| Impingement | Intraoperative | The incidence of impingement during intraoperative mobilization is documented; |
| General handling of instruments / containers | Intraoperative | Complaints or problems with the handling of instruments, implants or containers, instrument related issues |
| Complications | up to 5 years postoperatively | All complications in the postoperative course are recorded |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORStefan Landgraeber, Prof. Dr.
University Hospital, Saarland
Outcome results
None listed