Arthroplasty, Replacement, Hip, Follow-Up Study
Conditions
Keywords
Trochanter retaining joint replacement
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
Interventions
None listed
Sponsors
Aesculap AG
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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: 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: 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. |
| 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: 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 |
| 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 |
Countries
Germany
Outcome results
None listed