Evaluation of the DELTA Revision acetabular cup in hip arthroplasty
An Open Label, Observational, Prospective, Longitudinal Cohort Study to Evaluate Safety, Clinical and Radiographic Outcomes of Total Hip Arthroplasty With DELTA Revision Cup
This study is testing how well the DELTA Revision acetabular cup works for people with hip osteoarthritis who have had hip replacement surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 49 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Limacorporate S.p.a Industry-sponsored |
| Locations | 1 site (Otwock) |
| Trial ID | NCT06359301 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the clinical and radiographic outcomes of 49 patients who have undergone total hip arthroplasty using the DELTA Revision acetabular cup. The study aims to reflect real-life clinical practices, allowing clinicians to choose their methods of implantation based on local guidelines and practices. Participants will be monitored to assess the effectiveness and safety of the DELTA Revision cup in treating hip osteoarthritis.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are scheduled for total hip arthroplasty with the DELTA Revision acetabular cup.
Not a fit: Patients with contraindications for the DELTA Revision acetabular cup or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of the DELTA Revision acetabular cup, potentially improving outcomes for patients undergoing hip arthroplasty.
How similar studies have performed: While this study is observational and reflects current clinical practices, similar studies evaluating hip arthroplasty techniques have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Otwock
- Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP — Otwock, Poland (Recruiting)
Study contacts
- Principal investigator: Jerzy Bialecki — Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP
- Study coordinator: Federica Azzimonti
- Email: federica.azzimonti@limacorporate.com
- Phone: +39 377 5450940
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.