H-34 DELTA Revision Cup

NCT ID: NCT06359301

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-14

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Hip, Osteoarthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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DELTA Revision acetabular cup

Total hip arthroplasty

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Limacorporate S.p.a

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jerzy Bialecki

Role: PRINCIPAL_INVESTIGATOR

Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP

Locations

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Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP

Otwock, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Federica Azzimonti

Role: CONTACT

+39 377 5450940

Facility Contacts

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Jerzy Bialecki

Role: primary

Other Identifiers

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H-34

Identifier Type: -

Identifier Source: org_study_id

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