Back to resultsCemented TrendHip® - Multicenter PMCF Study on Total Indications (TRESTI)
Primary Purpose
Coxarthrosis; Primary, Coxarthrosis; Post-Traumatic, Necrosis, Femur Head
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Total Hip Arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Coxarthrosis; Primary focused on measuring Total Hip Arthroplasty, Hip Prosthesis, Elderly Patients, Bone Cement
Eligibility 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.
Sites / Locations
- St. Vincenz Hospital BrakelRecruiting
- St. Marien-HospitalRecruiting
- radprax Krankenhaus Plettenberg GmbHRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
TrendHip®
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Patient satisfaction with surgery result
Patient is asked for satisfaction with surgery result with a 4-point scale: very satisfied, satisfied, unsatisfied, very unsatisfied
Survival rate (Kaplan-Meier)
The survival of the TrendHip® Total Hip Prothesis will be analyzed using the "Kaplan-Meier".
Radiological Outcome: Migration of the stem in mm
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04943328
Brief Title
Cemented TrendHip® - Multicenter PMCF Study on Total Indications
Acronym
TRESTI
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aesculap AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coxarthrosis; Primary, Coxarthrosis; Post-Traumatic, Necrosis, Femur Head, Rheumatoid Arthritis, Fractures, Hip, Hip Dysplasia
Keywords
Total Hip Arthroplasty, Hip Prosthesis, Elderly Patients, Bone Cement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TrendHip®
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Total Hip Arthroplasty
Other Intervention Name(s)
TrendHip®
Intervention Description
cemented hip arthroplasty
Primary Outcome Measure Information:
Title
Change of functional outcome over five year follow-up period (Harris Hip Score)
Description
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.
Time Frame
preoperative (as available) and at two examinations during Follow-Up (1 year postop, 5 years postop)
Secondary Outcome Measure Information:
Title
Pain Assessment
Description
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.
Time Frame
at two examinations during Follow-Up (1 year postop, 5 years postop)
Title
Patient satisfaction with surgery result
Description
Patient is asked for satisfaction with surgery result with a 4-point scale: very satisfied, satisfied, unsatisfied, very unsatisfied
Time Frame
at two examinations during Follow-Up (1 year postop, 5 years postop)
Title
Survival rate (Kaplan-Meier)
Description
The survival of the TrendHip® Total Hip Prothesis will be analyzed using the "Kaplan-Meier".
Time Frame
at two examinations during Follow-Up (1 year postop, 5 years postop)
Title
Radiological Outcome: Migration of the stem in mm
Description
Migration of the stem is assessed in [mm] relative to postoperative x-rays
Time Frame
at two examinations during Follow-Up (1 year postop, 5 years postop)
Title
Radiological Outcome: Evaluation of bony osseointegration or conspicuous features of the stem
Description
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
Time Frame
at two examinations during Follow-Up (1 year postop, 5 years postop)
Title
Radiological Outcome: Heterotopic Ossification
Description
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
Time Frame
at two examinations during Follow-Up (1 year postop, 5 years postop)
Other Pre-specified Outcome Measures:
Title
Rate of Adverse and Serious Adverse Events
Description
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.
Time Frame
at two examinations during Follow-Up (1 year postop, 5 years postop)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria D Fernandez, Dr.
Phone
+49-7461-95-0
Email
maria_dolores.fernandez@aesculap.de
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Maenz, Dr.
Facility Information:
Facility Name
St. Vincenz Hospital Brakel
City
Brakel
ZIP/Postal Code
33034
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rolf Haaker, Prof. Dr.
Email
r.haaker@hwe.de
Facility Name
St. Marien-Hospital
City
Mülheim an der Ruhr
ZIP/Postal Code
45468
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcus Jäger, Prof.
First Name & Middle Initial & Last Name & Degree
Shareef Alkhateeb Alkhateeb
Facility Name
radprax Krankenhaus Plettenberg GmbH
City
Plettenberg
ZIP/Postal Code
58840
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre Scholz, Dr.
Email
ascholz@radprax.de
12. IPD Sharing Statement
Learn more about this trial
Cemented TrendHip® - Multicenter PMCF Study on Total Indications
We'll reach out to this number within 24 hrs