PMCF 8 Year Results TRJ®

Study Overview
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Brief Summary
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The intention of this Post Market Clinical Follow-Up study is to obtain mid-term results of the TRJ® endoprosthesis. Aim is to include those patients that have received a TRJ® Total Hip Arthroplasty in 2012 and already did participated in a clinical study taking place in 2014 to obtain 2 years results

Official Title
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Prospective Non-Interventional Post Market Clinical Follow-up Study TRJ® - 8 Years Results

Conditions
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Arthroplasty, Replacement, Hip, Follow-Up Study

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients have received a TRJ® prosthesis in 2012 Patient did participate in the 2 years results evaluation 2014 Patient gave his written consent for study participation Exclusion Criteria: patient is pregnant patient < 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate of the stem | The survival of the TRJ® stem prosthesis will be analyzed using the Kaplan-Meier. Isolated revisions of the inlay and / or of the acetabular components (with the stem being kept in place) are documented, but assessed separately. | at follow-up examination approximately 8 years after primary intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) | The Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) is a 40 items patient reported outcome score (PROM) designed specifically to evaluate the physical functionality of hip osteoarthritis patients. The HOOS offers 5 subgroups, each with 100 points as best result. | at follow-up examination approximately 8 years after primary intervention | 
| Harris Hip Score (HHS) | The Harris Hip Score (HHS) is one of the most used scores in total hip arthroplasty, mainly combining range of motion questions with questions regarding daily life activities. | at follow-up examination approximately 8 years after primary intervention | 
| Rate of Adverse and Serious Adverse Events | All Adverse Events (AE) / Serious Adverse Events (SAE) either observed during the follow-up examination, found in the patient file of the hospital or reported by the patient will be documented. Only those AE and SAE that could be related to the investigational product or the TRJ® Total Hip Arthroplasty procedure in 2012 are of interest. | at follow-up examination approximately 8 years after primary intervention | 
| Pain Assessment | Pain will be measured with a Visual Analogue Scale (VAS), at rest and when walking on flat ground. The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. | at follow-up examination approximately 8 years after primary intervention | 
| Radiological Outcome: Inlay wear | Inlay wear is assessed on AP x-rays of the cup and will be analysed according to the zones defined by DeLee and Charnley. Charnley and Gruen zones of the hip are distinct zones used in assessment of aseptic loosening in total hip joint replacements. | at follow-up examination approximately 8 years after primary intervention | 
| Radiological Outcome: Bony Osseointegration or conspicuous features of the cup | Bony Osseointegration or conspicuous features of the Cup are assessed on anterior-posterior x-rays of the cup and will be analysed according to the zones defined by DeLee and Charnley. Charnley and Gruen zones of the hip are distinct zones used in assessment of aseptic loosening in total hip joint replacements. | at follow-up examination approximately 8 years after primary intervention | 
| Radiological Outcome: Migration of the stem in mm | Migration of the stem is assessed in [mm] relative to discharge x-rays | at follow-up examination approximately 8 years after primary intervention | 
| Radiological Outcome: Bone resorption at the medial stem neck | Bone Resorption is assessed on anterior-posterior and lateral x-rays of the stem | at follow-up examination approximately 8 years after primary intervention | 
| Radiological Outcome: Bone resorption at the Trochanter Major | Bone Resorption is assessed on anterior-posterior and lateral x-rays of the stem | at follow-up examination approximately 8 years after primary intervention | 
| Radiological Outcome: Evaluation of bony osseointegration or conspicuous features of the stem | Bony Osseointegration or conspicuous features of the stem are assessed on anterior-posterior and lateral x-rays of the stem and will be analysed according to the zones defined by Gruen. Charnley and Gruen zones of the hip are distinct zones used in assessment of aseptic loosening in total hip joint replacements | at follow-up examination approximately 8 years after primary intervention | 
| Radiological Outcome: Heterotopic Ossification | Brooker classification divides heterotopic ossifications that form following total hip replacement to four classes. Class I: islands of bone within soft tissues around hip; Class II: bone spurs in pelvis or proximal end of femur leaving ≥1 cm between the opposing bone surfaces; Class III: bone spurs that extend from pelvis or the proximal end of femur, which reduce the space between the opposing bone surfaces to <1cm; Class IV: ankylosis of the hip on x-ray | at follow-up examination approximately 8 years after primary intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trochanter retaining joint replacement