Cemented TrendHip® - Multicenter PMCF Study on Total Indications

Not Applicable

Active, not recruiting

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

• Registration Number: NCT04943328
• Lead Sponsor: Aesculap AG

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-23
• Study First Submitted: 2021-06-23
• Study First Submitted QC: 2021-06-28
• Study First Posted: 2021-06-29
• Primary Completion: 2023-05-08
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-11
• Last Update Posted: 2025-09-17
• Study Completion: 2028-05-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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.
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: 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

Trial Locations

Locations (4)

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