H-34 DELTA Revision Cup

Recruiting

• Conditions: Hip, Osteoarthritis

• Registration Number: NCT06359301
• Lead Sponsor: Limacorporate S.p.a

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.

Study Timeline

• Study Start: 2021-09-14
• Study First Submitted: 2024-03-15
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-05
• Last Update Submitted: 2024-04-05
• Study First Posted: 2024-04-11
• Last Update Posted: 2024-04-11
• Primary Completion: 2026-03-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Harris Hip Score (HHS)	From preoperative to 2 years after surgery	Overall score from 0 to 100, with 100 being the best outcome

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP; 🇵🇱 Otwock, Poland