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
Study Type
OBSERVATIONAL
Enrollment
25
Dreifaltigkeitskrankenhaus Köln
Cologne, Germany
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.
Time frame: at follow-up examination approximately 8 years after primary intervention
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.
Time frame: at follow-up examination approximately 8 years after primary intervention
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.
Time frame: at follow-up examination approximately 8 years after primary intervention
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.
Time frame: at follow-up examination approximately 8 years after primary intervention
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: at follow-up examination approximately 8 years after primary intervention
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.
Time frame: at follow-up examination approximately 8 years after primary intervention
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.
Time frame: at follow-up examination approximately 8 years after primary intervention
Radiological Outcome: Migration of the stem in mm
Migration of the stem is assessed in \[mm\] relative to discharge x-rays
Time frame: at follow-up examination approximately 8 years after primary intervention
Radiological Outcome: Bone resorption at the medial stem neck
Bone Resorption is assessed on anterior-posterior and lateral x-rays of the stem
Time frame: at follow-up examination approximately 8 years after primary intervention
Radiological Outcome: Bone resorption at the Trochanter Major
Bone Resorption is assessed on anterior-posterior and lateral x-rays of the stem
Time frame: at follow-up examination approximately 8 years after primary intervention
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
Time frame: at follow-up examination approximately 8 years after primary intervention
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
Time frame: at follow-up examination approximately 8 years after primary intervention