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MASTER SL Clinical Study

Sponsor
Limacorporate S.p.a (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02126345
Collaborator
(none)
150
Enrollment
4
Locations
115
Anticipated Duration (Months)
37.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Device: MASTER SL femoral stem and DELTA TT acetabular cup

Study Design

Study Type:
Observational
Anticipated 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 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
MASTER SL

Device: MASTER SL femoral stem and DELTA TT acetabular cup

Outcome Measures

Primary Outcome Measures

  1. Rate of failure [3 years]

Secondary Outcome Measures

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

Other Outcome Measures

  1. Any undesirable side effects [3 and 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Royal Bournemouth Hospital NHS Foundation Trust Bournemouth United Kingdom
2 University Hospital Llandough Cardiff and Vale University Health Board Cardiff United Kingdom
3 The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust Oswestry United Kingdom
4 University Hospital Southampton NHS Foundation Trust Southampton United Kingdom

Sponsors and Collaborators

  • Limacorporate S.p.a

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Limacorporate S.p.a
ClinicalTrials.gov Identifier:
NCT02126345
Other Study ID Numbers:
  • H-14
First Posted:
Apr 30, 2014
Last Update Posted:
Sep 1, 2021
Last Verified:
Aug 1, 2021

Study Results

No Results Posted as of Sep 1, 2021