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Clinical Trials/NCT03908151
NCT03908151TerminatedNot Applicable

Five and Ten Year Results of the CMK21 Hip System

Smith & Nephew, Inc.2 sites in 1 country100 target enrollmentStarted: December 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
100
Locations
2
Primary Endpoint
Implant revision rate
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Five and ten year results of the CMK21 Hip system

Detailed Description

This study is being conducted to collect long term retrospective and prospective clinical and radiological data to evaluate the safety of revision rate and adverse events, and efficacy of clinical and patient assessment of the CMK21 hip stem in primary total hip arthroplasty.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Implant revision rate

Time Frame: 10 years

Listing of implants status at 10 years to analyse the survival rate

Device related adverse events

Time Frame: 5 and 10 years

Device related adverse events will be collected to monitor the safety

Radiographic assessment

Time Frame: 5 and 10 Years

the occurrence of cement tears/fractures

Secondary Outcomes

  • Harris Hip Score (HHS)(5 and 10 years)
  • EuroQoL Five Dimensions Questionnaire (EQ-5D)(5 and 10 years)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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Five and Ten Year Results of the CMK21 Hip... | Clinical Trial