MASTER SL Clinical Study

• Conditions: Patients Requiring Hip Replacement
• Interventions: Device: MASTER SL femoral stem and DELTA TT acetabular cup

• Registration Number: NCT02126345
• Lead Sponsor: Limacorporate S.p.a

Brief Summary

The purpose of this study is:

* to generate data to evaluate Orthopaedic Data Evaluation Panel (ODEP) rating to support existing short-term clinical results and CE documentation;

* to assess the clinical performance of the MASTER SL femoral stem and the DELTA TT acetabular cup under standard conditions of use;

* to determine any adverse events and assess whether they constitute risks when weighed against the intended performance of the device.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-24
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-30
• Study Start: 2014-05
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01
• Primary Completion: 2021-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Male and female ≥18 years;
• Radiologically confirmed diagnosis of primary osteoarthritis (OA) of the hip and suitable for primary total hip replacement;
• Life expectancy of >10 years;
• Voluntary written Informed Consent obtained.

Exclusion Criteria

• Prospect for recovery to independent mobility compromised by known coexistent, medical problems;
• Requiring revision hip replacement;
• Loss of abductor musculature, poor bone stock, or poor skin coverage around the hip joint;
• Previous organ transplant;
• Previous hip replacement (resurfacing or THR) on the contra-lateral side within the last 6 months;
• Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an Oxford Hip score <18 points;
• Body mass index (kg/m2) exceeds 40;
• Active or suspected infection;
• Known sensitivity to device materials;
• Women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MASTER SL	MASTER SL femoral stem and DELTA TT acetabular cup	-

Primary Outcome Measures

Name	Time	Method
Rate of failure	3 years

Secondary Outcome Measures

Name	Time	Method
Clinical progression measured with HHS score, OHS score, Non-Arthritic Hip Score, EQ-5D-5L	from baseline to all time-points

Trial Locations

Locations (4)

Royal Bournemouth Hospital NHS Foundation Trust; 🇬🇧 Bournemouth, United Kingdom

University Hospital Llandough Cardiff and Vale University Health Board; 🇬🇧 Cardiff, United Kingdom

The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust; 🇬🇧 Oswestry, United Kingdom

University Hospital Southampton NHS Foundation Trust; 🇬🇧 Southampton, United Kingdom