Cemented TrendHip® - Multicenter PMCF Study on Total Indications (TRESTI)

Aesculap

Status: Active, not recruiting

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

Treatments: Device: Total Hip Arthroplasty

Study type: Interventional

Funder types: Industry

Identifiers

NCT04943328

AAG-O-H-2105

Details and patient eligibility

About

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

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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119 participants in 1 patient group

TrendHip®

Other group

Treatment:

Device: Total Hip Arthroplasty