H-34 DELTA Revision Cup
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DELTA Revision acetabular cup.
- Who it may be relevant to
- Registry conditions: Hip, Osteoarthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open Label, Observational, Prospective, Longitudinal Cohort Study to Evaluate Safety, Clinical and Radiographic Outcomes of Total Hip Arthroplasty With DELTA Revision Cup
Overview
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
- Device DELTA Revision acetabular cup
Total hip arthroplasty
Primary outcome measures
- Harris Hip Score (HHS) [Time frame: From preoperative to 2 years after surgery]
Secondary outcome measures (5)
- ROM measurement [Time frame: From preoperative to 2 years after surgery]
- Oxforn Hip Score (OHS) [Time frame: From preoperative to 2 years after surgery]
- Survival rate [Time frame: 2 years]
- Radiographic implant evaluation and stability assessment of the DELTA Revision acetabular cup [Time frame: 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 [Time frame: From preoperative to 2 years after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Poland · 1 center
- Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP — Otwock
Identifiers
NCT: NCT06359301 · H-34