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MASTER SL Clinical Study

NCT02126345 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2021-09-01

No results posted yet for this study

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.

Conditions

  • Patients Requiring Hip Replacement

Interventions

DEVICE

MASTER SL femoral stem and DELTA TT acetabular cup

Sponsors & Collaborators

  • Limacorporate S.p.a

    lead INDUSTRY

Principal Investigators

  • Robert Middleton, MD · Royal Bournemouth Hospital NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2021-12-31
Completion
2023-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02126345 on ClinicalTrials.gov