An Open Label, Observational, Prospective, Longitudinal Cohort Study to Evaluate Safety, Clinical and Radiographic Outcomes of Total Hip Arthroplasty With DELTA Revision Cup

Limacorporate S.p.a1 site in 1 country49 target enrollmentSeptember 14, 2021

ConditionsHip, Osteoarthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hip, Osteoarthritis
Sponsor: Limacorporate S.p.a
Enrollment: 49
Locations: 1
Primary Endpoint: Harris Hip Score (HHS)
Status: Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 14, 2021

End Date

December 1, 2028

Last Updated

3 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Limacorporate S.p.a

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Harris Hip Score (HHS)

Time Frame: From preoperative to 2 years after surgery

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

Secondary Outcomes

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)
Radiographic implant evaluation and stability assessment of the DELTA Revision acetabular cup(From preoperative to 2 years after surgery)
ROM measurement(From preoperative to 2 years after surgery)
Oxforn Hip Score (OHS)(From preoperative to 2 years after surgery)
Survival rate(2 years)