TRESTI: Cemented TrendHip® - Multicenter PMCF Study on Total Indications

Sponsor

Aesculap AG (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04943328

Collaborator

(none)

120

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Coxarthrosis; Primary Coxarthrosis; Post-Traumatic Necrosis, Femur Head Rheumatoid Arthritis Fractures, Hip Hip Dysplasia	Device: Total Hip Arthroplasty	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Other: TrendHip®	Device: Total Hip Arthroplasty cemented hip arthroplasty Other Names: TrendHip®

Arm

Intervention/Treatment

Other: TrendHip®

Device: Total Hip Arthroplasty

cemented hip arthroplasty

Other Names:

TrendHip®

Outcome Measures

Primary Outcome Measures

Change of functional outcome over five year follow-up period (Harris Hip Score) [preoperative (as available) and at two examinations during Follow-Up (1 year postop, 5 years postop)]
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.

Secondary Outcome Measures

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.
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
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: 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
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

Other Outcome Measures

Rate of Adverse and Serious Adverse Events [at two examinations during Follow-Up (1 year postop, 5 years postop)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	St. Vincenz Hospital Brakel	Brakel	Germany	33034
2	St. Marien-Hospital	Mülheim an der Ruhr	Germany	45468
3	radprax Krankenhaus Plettenberg GmbH	Plettenberg	Germany	58840