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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

April 24, 2014
April 30, 2014
February 10, 2017
May 2014
December 2020   (Final data collection date for primary outcome measure)
Rate of failure [ Time Frame: 3 years ]
Same as current
Complete list of historical versions of study NCT02126345 on ClinicalTrials.gov Archive Site
Clinical progression measured with HHS score, OHS score, Non-Arthritic Hip Score, EQ-5D-5L [ Time Frame: from baseline to all time-points ]
Same as current
Any undesirable side effects [ Time Frame: 3 and 5 years ]
Same as current
 
MASTER SL Clinical Study
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients Requiring Hip Replacement
Patients Requiring Hip Replacement
Device: MASTER SL femoral stem and DELTA TT acetabular cup
MASTER SL
Intervention: Device: MASTER SL femoral stem and DELTA TT acetabular cup
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
200
December 2022
December 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
United Kingdom
 
 
NCT02126345
H-14
Not Provided
Not Provided
Not Provided
Limacorporate S.p.a
Limacorporate S.p.a
Not Provided
Principal Investigator: Robert Middleton, MD Royal Bournemouth Hospital NHS Foundation Trust
Limacorporate S.p.a
February 2017