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THis study is aimed to provide a clinical and radiographic evaluation of 49 suitable subjects who underwent a total hip arthroplasty with DELTA Revision acetabular cup.
This is an observational study designed to reflect real life clinical practice as closely as possible. Thus, clinicians are free to choose the method to implant and total hip arthroplasty in accordance with the current local Delta Revision acetabular cup Indication for Use and current clinical practice.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DELTA Revision acetabular cup | Device | Total hip arthroplasty |
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score (HHS) | Overall score from 0 to 100, with 100 being the best outcome | From preoperative to 2 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| ROM measurement | Functional changes in ROM measurements from pre-operative (baseline), discharge, 2 months, 6 months, 1 year and 2 years | From preoperative to 2 years after surgery |
| Oxforn Hip Score (OHS) |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of 49 consecutive subjects who underwent a THA with the DELTA Revision acetabular cup at the Independent Public Clinical Hospital Prof. Adama Grucy CMKP.
Subjects who do not meet all the inclusion criteria or meet any exclusion criteria are excluded from study participation and should be considered as a Screening Failure.
Subjects who meet all the inclusion criteria and none of the exclusion criteria and agree to participate in the study signing the Informed Consent Form are enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Federica Azzimonti | Contact | +39 377 5450940 | federica.azzimonti@limacorporate.com |
| Name | Affiliation | Role |
|---|---|---|
| Jerzy Bialecki | Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP | Recruiting | Otwock | 05-400 | Poland |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Overall score from 0 to 48, with 48 being the best outcome
| From preoperative to 2 years after surgery |
| Survival rate | Survival rate expressed with Kaplan-Meier estimator at 2 years after surgery | 2 years |
| Radiographic implant evaluation and stability assessment of the DELTA Revision acetabular cup | The treated hip is analyzed postoperatively based on anteroposterior and lateral x-rays view of the knee to check for radiographic stability and radiographically detectable complications | From preoperative to 2 years after surgery |
| Incidence, type and severity of all the Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), and Serious Adverse Device Effects (SADEs) occurred at each follow-up | From preoperative to 2 years after surgery |
| D012216 |
| Rheumatic Diseases |