Coxarthrosis; PrimaryTRESTINCT04943328

Cemented TrendHip® - Multicenter PMCF Study on Total Indications

A study testing Total Hip Arthroplasty in people with Coxarthrosis; Primary and Coxarthrosis; Post-Traumatic, run by Aesculap AG at 4 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coxarthrosis; Primary, Coxarthrosis; Post-Traumatic, Necrosis, Femur Head
What is being tested?: Total Hip Arthroplasty
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 119 participants
Where: 4 sitesGermany
Study dates: 12 Oct 2021to 8 May 2028
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Patient with shortened life expectancy.
The patient is unable to commit to the planned follow-up period.

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

St. Franziskus-Hospital
Ahlen, North Rhine-Westphalia, 59227
St. Vincenz Hospital Brakel
Brakel, 33034
St. Marien-Hospital
Mülheim, 45468
radprax Krankenhaus Plettenberg GmbH
Plettenberg, 58840

Other trials in Germany

About this study

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

Conditions: Coxarthrosis; Primary, Coxarthrosis; Post-Traumatic, Necrosis, Femur Head, Rheumatoid Arthritis, Fractures, Hip, Hip Dysplasia
Being tested: Total Hip Arthroplasty
Keywords: Total Hip Arthroplasty, Hip Prosthesis, Elderly Patients, Bone Cement
Medical subject headings: Osteoarthritis, Hip, Femur Head Necrosis, Arthritis, Rheumatoid, Hip Fractures, Hip Dislocation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Total Hip ArthroplastyDevice
Also called TrendHip®
cemented hip arthroplasty

Study groups in NCT04943328
Study group	Role	What they receive
TrendHip®	Other	Not described Receives: Device: Total Hip Arthroplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (6)

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.
Measured: 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
Measured: 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".
Measured: 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
Measured: 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
Measured: 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
Measured: at two examinations during Follow-Up (1 year postop, 5 years postop)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Oct 20218 May 2028

First posted29 Jun 2021
Study start12 Oct 2021
Primary completion8 May 2023
Study completion8 May 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Coxarthrosis; PrimaryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04943328
Sponsor's protocol ID: AAG-O-H-2105
Acronym: TRESTI
Status last verified: Feb 2026
First submitted: 23 Jun 2021
Last updated: 24 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®)
Osteoarthritis, Hip, Coxarthrosis; Primary
Recruiting
Ceramic Modular Dual Mobility in Primary Total Hip Arthroplasty (THA)
Coxarthrosis; Primary
Recruiting
Gait Initiation and Transition From Double to Single Support in Patients With Unilateral Primary Coxarthrosis
Primary; Coxarthrosis

All Coxarthrosis; Primary trials