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.
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
- Are there results?
- Not yet: the study is under way
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
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
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
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04943328
- Acronym / sponsor ID
- TRESTI / AAG-O-H-2105
- Conditions
- Coxarthrosis; Primary, Coxarthrosis; Post-Traumatic, Necrosis, Femur Head, Rheumatoid Arthritis, Fractures, Hip, Hip Dysplasia
- Keywords
- Total Hip Arthroplasty, Hip Prosthesis, Elderly Patients, Bone Cement
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 May 2028 (estimated)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TrendHip® | Other | Device: Total Hip Arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patient with shortened life expectancy.
- The patient is unable to commit to the planned follow-up period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Hip ArthroplastyAlso: TrendHip®cemented hip arthroplasty | Device | TrendHip® |
Primary outcome
Change of functional outcome over five year follow-up period (modified Harris Hip Score)
Time frame: preoperative (as available) and at two examinations during Follow-Up (1 year postop, 5 years postop)
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.
6 secondary outcomes
Pain Assessment
Time frame: at two examinations during Follow-Up (1 year postop, 5 years postop)
Patient satisfaction with surgery result
Time frame: at two examinations during Follow-Up (1 year postop, 5 years postop)
Survival rate (Kaplan-Meier)
Time frame: at two examinations during Follow-Up (1 year postop, 5 years postop)
Radiological Outcome: Migration of the stem in mm
Time frame: at two examinations during Follow-Up (1 year postop, 5 years postop)
Radiological Outcome: Evaluation of bony osseointegration or conspicuous features of the stem
Time frame: at two examinations during Follow-Up (1 year postop, 5 years postop)
Radiological Outcome: Heterotopic Ossification
Time frame: at two examinations during Follow-Up (1 year postop, 5 years postop)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Hip Arthroplasty in people with Coxarthrosis; Primary and Coxarthrosis; Post-Traumatic, run by Aesculap AG at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of functional outcome over five year follow-up period (modified Harris Hip Score) (time frame: preoperative (as available) and at two examinations during Follow-Up (1 year postop, 5 years postop)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.