PMCF 8 Year Results TRJ®

Completed

• Conditions: Arthroplasty, Replacement, Hip; Follow-Up Study

• Registration Number: NCT04542174
• Lead Sponsor: Aesculap AG

Brief Summary

The intention of this Post Market Clinical Follow-Up study is to obtain mid-term results of the TRJ® endoprosthesis. Aim is to include those patients that have received a TRJ® Total Hip Arthroplasty in 2012 and already did participated in a clinical study taking place in 2014 to obtain 2 years results

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-02
• Study First Posted: 2020-09-09
• Study Start: 2020-09-10
• Primary Completion: 2021-09-26
• Study Completion: 2021-09-26
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• patients have received a TRJ® prosthesis in 2012
• Patient did participate in the 2 years results evaluation 2014
• Patient gave his written consent for study participation

Exclusion Criteria

• patient is pregnant
• patient < 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival rate of the stem	at follow-up examination approximately 8 years after primary intervention	The survival of the TRJ® stem prosthesis will be analyzed using the "Kaplan-Meier". Isolated revisions of the inlay and / or of the acetabular components (with the stem being kept in place) are documented, but assessed separately.

Secondary Outcome Measures

Name	Time	Method
Harris Hip Score (HHS)	at follow-up examination approximately 8 years after primary intervention	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.
Rate of Adverse and Serious Adverse Events	at follow-up examination approximately 8 years after primary intervention	All Adverse Events (AE) / Serious Adverse Events (SAE) either observed during the follow-up examination, found in the patient file of the hospital or reported by the patient will be documented. Only those AE and SAE that could be related to the investigational product or the TRJ® Total Hip Arthroplasty procedure in 2012 are of interest.
Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)	at follow-up examination approximately 8 years after primary intervention	The Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) is a 40 items patient reported outcome score (PROM) designed specifically to evaluate the physical functionality of hip osteoarthritis patients. The HOOS offers 5 subgroups, each with 100 points as best result.
Radiological Outcome: Bone resorption at the medial stem neck	at follow-up examination approximately 8 years after primary intervention	Bone Resorption is assessed on anterior-posterior and lateral x-rays of the stem
Radiological Outcome: Bone resorption at the Trochanter Major	at follow-up examination approximately 8 years after primary intervention	Bone Resorption is assessed on anterior-posterior and lateral x-rays of the stem
Radiological Outcome: Bony Osseointegration or conspicuous features of the cup	at follow-up examination approximately 8 years after primary intervention	Bony Osseointegration or conspicuous features of the Cup are assessed on anterior-posterior x-rays of the cup and will be analysed according to the zones defined by DeLee and Charnley. "Charnley" and "Gruen" zones of the hip are distinct zones used in assessment of aseptic loosening in total hip joint replacements.
Radiological Outcome: Inlay wear	at follow-up examination approximately 8 years after primary intervention	Inlay wear is assessed on AP x-rays of the cup and will be analysed according to the zones defined by DeLee and Charnley. "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 follow-up examination approximately 8 years after primary intervention	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
Radiological Outcome: Migration of the stem in mm	at follow-up examination approximately 8 years after primary intervention	Migration of the stem is assessed in \[mm\] relative to discharge x-rays
Pain Assessment	at follow-up examination approximately 8 years after primary intervention	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 patient is asked to mark their current pain level on the line.
Radiological Outcome: Evaluation of bony osseointegration or conspicuous features of the stem	at follow-up examination approximately 8 years after primary intervention	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

Trial Locations

Locations (1)

Dreifaltigkeitskrankenhaus Köln; 🇩🇪 Köln, Germany