Follow-Up of the Prevision® Hip Stem

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to represent the treatment reality at the study site and to draw conclusions from cases of failure or suboptimal outcome. Potential risk factors for revision surgery, suboptimal outcome or radiologic sign of loosening, bone non-union or stem subsidence will be evaluated. Next to the functional outcome, stem subsidence will be used as an important indicator for a stable fixation of the revision stem.

Official Title
-----------------
Retrospective Follow-Up of the Prevision® Hip Stem in a Consecutive Case Series

Conditions
-----------------
Periprosthetic Fracture Around Prosthetic Joint Implant, Aseptic Loosening of Prosthetic Joint

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients implanted with a Prevision® hip stem at the study site between 2014 and 2019 Written informed patient consent Exclusion Criteria: - Patients < 18 years at surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip stem survival measured by Kaplan-Meier | The primary endpoint of the study is hip stem survival, which is a common indicator for implant performance, which can also be used for comparison with implant registry data. | One scheduled Follow-Up visit per patient, 2-7 years after initial implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Outcome: Oxford Hip Score | The Oxford Hip Score is a 12-item questionnaire that assesses hip function and pain. The score ranges between 12 and 60, with a lower score indicating less disability | One scheduled Follow-Up visit per patient, 2-7 years after initial implantation | 
| Patient satisfaction with their endoprosthetic revision treatment | The Patients are asked to grade their level of satisfaction with the outcome of the surgery at time of follow-up, with the grades: very dissatisfied, dissatisfied, satisfied, very satisfied. The grades may be summarized as satisfied vs. dissatisfied. | One scheduled Follow-Up visit per patient, 2-7 years after initial implantation | 
| Radiological evaluation (standard x-rays): Bone healing | Union of the osteotomy o Healing of the fracture and of the greater trochanter, if applicable | One scheduled Follow-Up visit per patient, 2-7 years after initial implantation | 
| Radiological evaluation (standard x-rays): osseointegration | Distal and proximal radiographic bone ingrowth and Qualitative proximal remodeling | One scheduled Follow-Up visit per patient, 2-7 years after initial implantation | 
| Radiological evaluation (standard x-rays): radiographic loosening | Signs of radiographic loosening in the distal fixation zone | One scheduled Follow-Up visit per patient, 2-7 years after initial implantation | 
| Radiological evaluation (standard x-rays): stem subsidence | Stem subsidence from ap x-rays using landmarks of the femur (typically lesser trochanter) and of the prosthesis | One scheduled Follow-Up visit per patient, 2-7 years after initial implantation | 
| Leg length difference | Discrepancy of leg length is often considered to be a problem after total hip replacement and can adversely affect an otherwise excellent outcome and may be associated with patient dissatisfaction. | One scheduled Follow-Up visit per patient, 2-7 years after initial implantation | 
| Descriptive Analysis of (Serious) adverse events | (Serious) adverse events that are potentially related to the Total hip arthroplasty (THA) procedure or the THA implants will be recorded. These are events as reported by the patient, observed in the follow-up examinations or taken from the patient record | One scheduled Follow-Up visit per patient, 2-7 years after initial implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
implant failure, failed primary hip arthroplasty, arthroplasty, replacement, hip, severe bone defects, complex bone fractures, septic loosening, poor bone remodeling