H-34 DELTA Revision Cup

NCT06359301 | Recruiting

• 1 other identifier: H-34
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip, Osteoarthritis

Keywords

revision

Outcome Measures

Primary Outcomes (1)

• Harris Hip Score (HHS)

  Overall score from 0 to 100, with 100 being the best outcome

  From preoperative to 2 years after surgery

Secondary Outcomes (5)

• ROM measurement

  From preoperative to 2 years after surgery

• Oxforn Hip Score (OHS)

  From preoperative to 2 years after surgery

• Survival rate

  2 years

• Radiographic implant evaluation and stability assessment of the DELTA Revision acetabular cup

  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

Interventions

DELTA Revision acetabular cup DEVICE

Total hip arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Limacorporate S.p.a: lead

Study Sites (1)

Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP

Otwock, 05-400, Poland

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jerzy Bialecki

  Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federica Azzimonti

CONTACT

+39 377 5450940; federica.azzimonti@limacorporate.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: April 11, 2024
• Study Start: September 14, 2021
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)