An interventional study of Total Hip Arthroplasty in Coxarthrosis; Primary, Coxarthrosis; Post-Traumatic and Necrosis, Femur Head, sponsored by Aesculap AG. Active, not recruiting at 4 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by Aesculap AG (part of B. Braun) · Not applicable, Interventional, and Treatment
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
641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.
This study's enrollment of 119 is above the median of 90 across 457 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Aesculap AG is the lead sponsor of 105 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion: Inclusion criteria
Exclusion: Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Total Hip Arthroplasty
cemented hip arthroplasty
Also known as: TrendHip®
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
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)
Rate of Adverse and Serious Adverse Events
All Adverse Events (AE) / Serious Adverse Events (SAE) observed during the follow-up examination or reported by the patient will be documented. Only those AE and SAE that could be related to the investigational product or the TrendHip® Total Hip Arthroplasty procedure are of interest.
Time frame: at two examinations during Follow-Up (1 year postop, 5 years postop)
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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