MASTER SL Clinical Study

August 31, 2021 updated by: Limacorporate S.p.a

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bournemouth, United Kingdom
        • Royal Bournemouth Hospital NHS Foundation Trust
      • Cardiff, United Kingdom
        • University Hospital Llandough Cardiff and Vale University Health Board
      • Oswestry, United Kingdom
        • The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
      • Southampton, United Kingdom
        • University Hospital Southampton NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients Requiring Hip Replacement

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MASTER SL
Device: MASTER SL femoral stem and DELTA TT acetabular cup

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of failure
Time Frame: 3 years
3 years

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Any undesirable side effects
Time Frame: 3 and 5 years
3 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Limacorporate S.p.a

Investigators

  • Principal Investigator: Robert Middleton, MD, Royal Bournemouth Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

April 24, 2014

First Submitted That Met QC Criteria

April 28, 2014

First Posted (ESTIMATE)

April 30, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • H-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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