Cemented TrendHip® - Multicenter PMCF Study on Total Indications

Study Overview
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Brief Summary
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This Post Market Clinical Follow-Up (PMCF) study to evaluate the performance and safety of the cemented TrendHip® stem in a prospective follow-up study with patients who underwent a hip arthroplasty with the investigational product (representative of usual clinical practice), at two follow-up examinations

Official Title
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Post Market Clinical Follow-Up (PMCF) Study to Evaluate the Performance and Safety of the Cemented TrendHip® Stem in a Prospective Follow-up Study

Conditions
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Fractures, Hip, Coxarthrosis; Primary, Coxarthrosis; Post-Traumatic, Necrosis, Femur Head, Rheumatoid Arthritis, Hip Dysplasia

Intervention / Treatment
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* Device: Total Hip Arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion: Inclusion criteria Patient older than 18 years. Patient who undergo / underwent a hip arthroplasty with cemented TrendHip® femoral stem according to the indications for implantation specified in the Instructions for Use. Patient not opposing participation in the study. Exclusion: Exclusion criteria Patient with shortened life expectancy. The patient is unable to commit to the planned follow-up period.

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TrendHip®<br> | Device: Total Hip Arthroplasty<br>* cemented hip arthroplasty<br>* Other names: TrendHip®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of functional outcome over five year follow-up period (Harris Hip Score) | 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. | preoperative (as available) and at two examinations during Follow-Up (1 year postop, 5 years postop) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 patients are asked to mark their current pain level on the line. | at two examinations during Follow-Up (1 year postop, 5 years postop) | 
| Patient satisfaction with surgery result | Patient is asked for satisfaction with surgery result with a 4-point scale: very satisfied, satisfied, unsatisfied, very unsatisfied | at two examinations during Follow-Up (1 year postop, 5 years postop) | 
| Survival rate (Kaplan-Meier) | The survival of the TrendHip® Total Hip Prothesis will be analyzed using the Kaplan-Meier. | at two examinations during Follow-Up (1 year postop, 5 years postop) | 
| Radiological Outcome: Migration of the stem in mm | Migration of the stem is assessed in [mm] relative to postoperative x-rays | at two examinations during Follow-Up (1 year postop, 5 years postop) | 
| 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 two examinations during Follow-Up (1 year postop, 5 years postop) | 
| 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 two examinations during Follow-Up (1 year postop, 5 years postop) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Hip Arthroplasty, Hip Prosthesis, Elderly Patients, Bone Cement