Cemented TrendHip® - Multicenter PMCF Study on Total Indications

Rheumatoid Arthritis Clinical Trial

— TRESTI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04943328
• Other study ID #: AAG-O-H-2105
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: October 2028

Study information

• Verified date: February 2024
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 122
• Est. completion date: October 2028
• Est. primary completion date: January 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coxarthrosis; Primary
• Developmental Dysplasia of the Hip
• Femur Head Necrosis
• Fractures, Hip
• Hip Dislocation
• Hip Dislocation, Congenital
• Hip Dysplasia
• Hip Fractures
• Necrosis
• Necrosis, Femur Head
• Osteoarthritis, Hip
• Rheumatoid Arthritis

Intervention

Device:
• Total Hip Arthroplasty
cemented hip arthroplasty

Locations

Country	Name	City	State
Germany	St. Franziskus-Hospital	Ahlen	Nordrhein-Westfalen
Germany	St. Vincenz Hospital Brakel	Brakel
Germany	St. Marien-Hospital	Mülheim an der Ruhr
Germany	radprax Krankenhaus Plettenberg GmbH	Plettenberg

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	at two examinations during Follow-Up (1 year postop, 5 years postop)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)