DELTA Multihole TT Study

• Conditions: Hip Osteoarthritis; Arthroplasty Complications; Hip Dysplasia

• Registration Number: NCT04375345
• Lead Sponsor: University Hospital Bratislava

Brief Summary

A retrospective study evaluating clinical and radiographic early outcomes of total hip arthroplasty and revision hip arthroplasty with DELTA Multihole TT cup.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-23
• Study First Submitted: 2020-04-29
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-04
• Last Update Submitted: 2020-05-04
• Study First Posted: 2020-05-05
• Last Update Posted: 2020-05-05
• Primary Completion: 2022-01-23
• Study Completion: 2022-03-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of HHS score equal or greater than "Good" at 2 years after surgery	Month 24

Secondary Outcome Measures

Name	Time	Method
Survival rate	Month 24	Kaplan-Meier
Incidence of device-related Adverse Events / Serious Adverse Events	Intraoperative, Week 6, Week 12, Month 6, Month 12, Month 24
Radiographic implant evaluation and stability assessment	Week 6, Week 12, Month 6, Month 12, Month 24	Migration over 2 mm or over 5 degrees
Patients recovery at 2 years after surgery evaluated using the 5-level EQ-5D version (EQ-5D-5L).	Month 24	The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).

Trial Locations

Locations (1)

2nd University Department of Orthopaedic and Trauma Surgery Comenius University Faculty of Medicine; 🇸🇰 Bratislava, Slovakia