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Status unknownNCT02126345Updated Sep 1, 2021

MASTER SL Clinical Study

An observational study in Patients Requiring Hip Replacement, sponsored by Limacorporate S.p.a. Status unknown at 4 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-01.

Sponsored by Limacorporate S.p.a · Observational

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

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.
02

Conditions studied

  • Patients Requiring Hip Replacement
03

In context

Lead sponsor

Limacorporate S.p.a is the lead sponsor of 31 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients Requiring Hip Replacement

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • MASTER SL

    Device: MASTER SL femoral stem and DELTA TT acetabular cup

Interventions

  • DeviceMASTER SL femoral stem and DELTA TT acetabular cup
06

What researchers measure

Primary outcomes

  1. Rate of failure

    Time frame: 3 years

Secondary outcomes

  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 outcomes

  1. Any undesirable side effects

    Time frame: 3 and 5 years

07

Study locations

4 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02126345
Lead sponsor
Limacorporate S.p.a
Responsible party
Sponsor
First posted
Apr 30, 2014
Start date
May 2014
Primary completion
Dec 2021 (estimated)
Completion
Dec 2023 (estimated)
Last update
Sep 1, 2021

Study contacts

Robert Middleton, MD
principal investigator · Royal Bournemouth Hospital NHS Foundation Trust
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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