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MASTER SL Clinical Study

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ClinicalTrials.gov Identifier: NCT02126345
Recruitment Status : Recruiting
First Posted : April 30, 2014
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Patients Requiring Hip Replacement Device: MASTER SL femoral stem and DELTA TT acetabular cup

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : May 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

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



Primary Outcome Measures :
  1. Rate of failure [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Clinical progression measured with HHS score, OHS score, Non-Arthritic Hip Score, EQ-5D-5L [ Time Frame: from baseline to all time-points ]

Other Outcome Measures:
  1. Any undesirable side effects [ Time Frame: 3 and 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients Requiring Hip Replacement
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126345


Locations
United Kingdom
Royal Bournemouth Hospital NHS Foundation Trust Recruiting
Bournemouth, United Kingdom
Contact: Ian Leadbitter       Ian.leadbitter@rbch.nhs.uk   
Principal Investigator: Robert Middleton, MD         
University Hospital Llandough Cardiff and Vale University Health Board Recruiting
Cardiff, United Kingdom
Contact: Claire Nott    00442920 716689    Claire.Nott@wales.nhs.uk   
Principal Investigator: Stephen Jones, MD         
The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust Recruiting
Oswestry, United Kingdom
Contact: Robin Banerjee, MD    +44 1691 404139    robin.banerjee@rjah.nhs.uk   
Principal Investigator: Robin Banerjee, MD         
University Hospital Southampton NHS Foundation Trust Recruiting
Southampton, United Kingdom
Contact: Emma Ray    00442381 208591    Emma.Ray@uhs.nhs.uk   
Principal Investigator: Simon Tilley, MD         
Sponsors and Collaborators
Limacorporate S.p.a
Investigators
Principal Investigator: Robert Middleton, MD Royal Bournemouth Hospital NHS Foundation Trust

Responsible Party: Limacorporate S.p.a
ClinicalTrials.gov Identifier: NCT02126345     History of Changes
Other Study ID Numbers: H-14
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017