Coxarthrosis; Post-Traumatic, Coxarthrosis; Primary, Fractures, Hip, Hip Dysplasia, Necrosis, Femur Head, Rheumatoid Arthritis
Conditions
Keywords
Total Hip Arthroplasty, Hip Prosthesis, Elderly Patients, Bone Cement
Brief summary
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
Interventions
DEVICETotal Hip Arthroplasty
cemented hip arthroplasty
Sponsors
Aesculap AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of functional outcome over five year follow-up period (modified Harris Hip Score) | preoperative (as available) and at two examinations during Follow-Up (1 year postop, 5 years postop) | The modified Harris Hip Score (mHHS) as patient-reported outcome measure and evaluated one-year and five-years postoperatively. The mHHS is a validated and disease-specific instrument commonly used to assess outcomes in total hip arthroplasty. The domains covered are pain, function (gait), and functional activities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction with surgery result | at two examinations during Follow-Up (1 year postop, 5 years postop) | Patient is asked for satisfaction with surgery result with a 4-point scale: very satisfied, satisfied, unsatisfied, very unsatisfied |
| Survival rate (Kaplan-Meier) | at two examinations during Follow-Up (1 year postop, 5 years postop) | The survival of the TrendHip® Total Hip Prothesis will be analyzed using the "Kaplan-Meier". |
| Radiological Outcome: Migration of the stem in mm | at two examinations during Follow-Up (1 year postop, 5 years postop) | Migration of the stem is assessed in \[mm\] relative to postoperative x-rays |
| Radiological Outcome: Evaluation of bony osseointegration or conspicuous features of the stem | at two examinations during Follow-Up (1 year postop, 5 years postop) | 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 |
| Radiological Outcome: Heterotopic Ossification | at two examinations during Follow-Up (1 year postop, 5 years postop) | 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 |
| Pain Assessment | at two examinations during Follow-Up (1 year postop, 5 years postop) | 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. |
Countries
Germany
Outcome results
None listed