MASTER SL Clinical Study

Patients Requiring Hip Replacement Clinical Trial

Official title:

A Prospective, Observational, Multi-centre, Cohort Study of the MASTER SL Femoral Stem and the DELTA TT Acetabular Cup in Patients With Degenerative Disease of the Hip

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02126345
• Other study ID #: H-14
• Status: Active, not recruiting
• Start date: May 2014
• Est. completion date: December 2023

Study information

• Verified date: August 2021
• Source: Limacorporate S.p.a
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 2023
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Patients Requiring Hip Replacement

Intervention

Device:
• MASTER SL femoral stem and DELTA TT acetabular cup

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Limacorporate S.p.a

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Any undesirable side effects		3 and 5 years
Primary	Rate of failure		3 years
Secondary	Clinical progression measured with HHS score, OHS score, Non-Arthritic Hip Score, EQ-5D-5L		from baseline to all time-points