PMCF 8 Year Results TRJ®

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

Prospective Non-Interventional Post Market Clinical Follow-up Study TRJ® - 8 Years Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04542174
• Other study ID #: AAG-O-H-1908
• Status: Completed
• Start date: September 10, 2020
• Est. completion date: September 26, 2021

Study information

• Verified date: January 2022
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 26, 2021
• Est. primary completion date: September 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip
• Follow-Up Study

Locations

Country	Name	City	State
Germany	Dreifaltigkeitskrankenhaus Köln	Köln

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate of the stem	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.	at follow-up examination approximately 8 years after primary intervention
Secondary	Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)	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.	at follow-up examination approximately 8 years after primary intervention
Secondary	Harris Hip Score (HHS)	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.	at follow-up examination approximately 8 years after primary intervention
Secondary	Rate of Adverse and Serious Adverse Events	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.	at follow-up examination approximately 8 years after primary intervention
Secondary	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 patient is asked to mark their current pain level on the line.	at follow-up examination approximately 8 years after primary intervention
Secondary	Radiological Outcome: Inlay wear	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.	at follow-up examination approximately 8 years after primary intervention
Secondary	Radiological Outcome: Bony Osseointegration or conspicuous features of the cup	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.	at follow-up examination approximately 8 years after primary intervention
Secondary	Radiological Outcome: Migration of the stem in mm	Migration of the stem is assessed in [mm] relative to discharge x-rays	at follow-up examination approximately 8 years after primary intervention
Secondary	Radiological Outcome: Bone resorption at the medial stem neck	Bone Resorption is assessed on anterior-posterior and lateral x-rays of the stem	at follow-up examination approximately 8 years after primary intervention
Secondary	Radiological Outcome: Bone resorption at the Trochanter Major	Bone Resorption is assessed on anterior-posterior and lateral x-rays of the stem	at follow-up examination approximately 8 years after primary intervention
Secondary	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 follow-up examination approximately 8 years after primary intervention
Secondary	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 follow-up examination approximately 8 years after primary intervention