H-34 DELTA Revision Cup
ConditionHip, Osteoarthritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLimacorporate S.p.a
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
DELTA Revision acetabular cup
DeviceTotal hip arthroplasty
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Harris Hip Score (HHS)
Overall score from 0 to 100, with 100 being the best outcome
Time frame
From preoperative to 2 years after surgerySecondary outcomes
1
ROM measurement
Functional changes in ROM measurements from pre-operative (baseline), discharge, 2 months, 6 months, 1 year and 2 years
Time frame
From preoperative to 2 years after surgery2
Oxforn Hip Score (OHS)
Overall score from 0 to 48, with 48 being the best outcome
Time frame
From preoperative to 2 years after surgery3
Survival rate
Survival rate expressed with Kaplan-Meier estimator at 2 years after surgery
Time frame
2 years4
Radiographic implant evaluation and stability assessment of the DELTA Revision acetabular cup
The treated hip is analyzed postoperatively based on anteroposterior and lateral x-rays view of the knee to check for radiographic stability and radiographically detectable complications
Time frame
From preoperative to 2 years after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov