MASTER SL Clinical Study | NCT02126345

Studies
MASTER SL Clinical Study

NCT02126345

Sponsor

Limacorporate S.p.a

Status

Unknown status

Last Update Posted

Sep 1, 2021Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Patients Requiring Hip Replacement

Interventions

MASTER SL femoral stem and DELTA TT acetabular cup

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014Actual

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Apr 24, 2014

First Submission Date that Met QC Criteria

Apr 28, 2014

First Posted Date

Apr 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2021

Last Update Posted Date

Sep 1, 2021Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Label	Type	Description	Intervention Names
MASTER SL			Device: MASTER SL femoral stem and DELTA TT acetabular cup

Name	Type	Description	Arm Group Labels	Other Names
MASTER SL femoral stem and DELTA TT acetabular cup	Device		MASTER SL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of failure		3 years

Secondary Outcomes

Measure	Description	Time Frame
Clinical progression measured with HHS score, OHS score, Non-Arthritic Hip Score, EQ-5D-5L		from baseline to all time-points

Other Outcomes

Measure	Description	Time Frame
Any undesirable side effects		3 and 5 years

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients Requiring Hip Replacement

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Middleton, MD	Royal Bournemouth Hospital NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Bournemouth Hospital NHS Foundation Trust		Bournemouth			United Kingdom
University Hospital Llandough Cardiff and Vale University Health Board