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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Rheumatoid Arthritis; Hip Dysplasia; Fractures, Hip; Necrosis, Femur Head; Coxarthrosis; Primary; Coxarthrosis; Post-Traumatic
• Intervention / Treatment: Device: Total Hip Arthroplasty

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria D Fernandez, Dr.; Phone Number: +49-7461-95-0; Email: maria_dolores.fernandez@aesculap.de
• Study Contact Backup: Name: Stefan Maenz, Dr.

Study Locations

• Germany
  • Brakel, Germany, 33034
    • St. Vincenz Hospital Brakel
  • Mülheim an der Ruhr, Germany, 45468
    • St. Marien-Hospital
  • Plettenberg, Germany, 58840
    • radprax Krankenhaus Plettenberg GmbH
  • Nordrhein-Westfalen
    • Ahlen, Nordrhein-Westfalen, Germany, 59227
      • St. Franziskus-Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Aesculap AG

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): January 12, 2024
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: June 28, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Total Hip Arthroplasty; Elderly Patients; Hip Prosthesis; Bone Cement
• Additional Relevant MeSH Terms: Pathologic Processes; Fractures, Bone; Wounds and Injuries; Leg Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Bone Diseases; Femoral Fractures; Hip Injuries; Osteonecrosis; Musculoskeletal Abnormalities; Joint Dislocations; Osteoarthritis; Necrosis; Hip Fractures; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Osteoarthritis, Hip; Femur Head Necrosis
• Other Study ID Numbers: AAG-O-H-2105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No