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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
119
cemented hip arthroplasty
St. Franziskus-Hospital
Ahlen, North Rhine-Westphalia, Germany
St. Vincenz Hospital Brakel
Brakel, Germany
St. Marien-Hospital
Mülheim, Germany
radprax Krankenhaus Plettenberg GmbH
Plettenberg, Germany
Change of functional outcome over five year follow-up period (modified Harris Hip Score)
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.
Time frame: preoperative (as available) and at two examinations during Follow-Up (1 year postop, 5 years postop)
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.
Time frame: 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
Time frame: 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".
Time frame: 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
Time frame: at two examinations during Follow-Up (1 year postop, 5 years postop)
Radiological Outcome: Evaluation of bony osseointegration or conspicuous features of the stem
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: 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
Time frame: at two examinations during Follow-Up (1 year postop, 5 years postop)