H-34 DELTA Revision Cup

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 aimed to provide a clinical and radiographic evaluation of 49 suitable subjects who underwent a total hip arthroplasty with DELTA Revision acetabular cup.

Study Overview

• Status: Recruiting
• Conditions: Hip, Osteoarthritis
• Intervention / Treatment: Device: 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 Type: Observational
• Enrollment (Estimated): 49

Contacts and Locations

• Study Contact: Name: Federica Azzimonti; Phone Number: +39 377 5450940; Email: federica.azzimonti@limacorporate.com

Study Locations

• Poland
  • Otwock, Poland, 05-400
    • Recruiting
    • Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP
    • Contact: Jerzy Bialecki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Limacorporate S.p.a
• Investigators: Principal Investigator: Jerzy Bialecki, Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: revision
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: H-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No