Clinical trial NCT06359301: H-34 DELTA Revision Cup
Official title: An Open Label, Observational, Prospective, Longitudinal Cohort Study to Evaluate Safety, Clinical and Radiographic Outcomes of Total Hip Arthroplasty With DELTA Revision Cup
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip, Osteoarthritis
Keywords: revision
Lead sponsor: Limacorporate S.p.a
Sponsor class: INDUSTRY
First posted: 2024-04-11
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Harris Hip Score (HHS)
timeFrame: From preoperative to 2 years after surgery
Secondary outcomes:
measure: ROM measurement
timeFrame: From preoperative to 2 years after surgery
measure: Oxforn Hip Score (OHS)
timeFrame: From preoperative to 2 years after surgery
measure: Survival rate
timeFrame: 2 years
measure: Radiographic implant evaluation and stability assessment of the DELTA Revision acetabular cup
timeFrame: From preoperative to 2 years after surgery
measure: 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
timeFrame: From preoperative to 2 years after surgery
Other outcomes:
Locations:
city: Otwock
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP
Study officials:
affiliation: Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP
name: Jerzy Bialecki
role: PRINCIPAL_INVESTIGATOR
References: