Hip, Osteoarthritis
Conditions
Keywords
revision
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDELTA Revision acetabular cup
Total hip arthroplasty
Sponsors
Limacorporate S.p.a
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male or female in whom a decision has already been made to perform a total hip arthroplasty with DELTA Revision acetabular cup as per indication for use. The decision to implant DELTA revision acetabular cup must be taken prior to, and independently from the decision to enroll the patient. This decision should be made in accorsance with routine clinical practice at the study site concerned. * Age ≥ 18 years old * All patients mist give written informed consent approved by the study site's Institutinal Review Board (IRB)/Ethical Committee (EC) * Patient is able to comply with the protocol
Exclusion criteria
* Adult patients with any DELTA Revision acetabular cup contraindication for use as reported in the current local instruction for use. * For female patiens, current pregnancy and/or lactation or planning a pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score (HHS) | From preoperative to 2 years after surgery | Overall score from 0 to 100, with 100 being the best outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ROM measurement | From preoperative to 2 years after surgery | Functional changes in ROM measurements from pre-operative (baseline), discharge, 2 months, 6 months, 1 year and 2 years |
| Oxforn Hip Score (OHS) | From preoperative to 2 years after surgery | Overall score from 0 to 48, with 48 being the best outcome |
| Survival rate | 2 years | Survival rate expressed with Kaplan-Meier estimator at 2 years after surgery |
| Radiographic implant evaluation and stability assessment of the DELTA Revision acetabular cup | From preoperative to 2 years after surgery | 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 |
| 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 | — |
Countries
Poland
Contacts
CONTACTFederica Azzimonti
PRINCIPAL_INVESTIGATORJerzy Bialecki
Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP
Outcome results
None listed