RecruitingNCT06359301
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
Sponsor
Limacorporate S.p.a
Enrollment
49 participants
Start Date
Sep 14, 2021
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria2
- 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
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Interventions
DEVICEDELTA Revision acetabular cup
Total hip arthroplasty
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06359301
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