Five and Ten Year Results of the CMK21 Hip System

Terminated

• Conditions: Osteoarthritis

• Registration Number: NCT03908151
• Lead Sponsor: Smith & Nephew, Inc.

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 Timeline

• Study Start: 2010-12
• Primary Completion: 2016-08
• Study First Submitted: 2016-08-26
• Study Completion: 2016-10
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-05
• Last Update Submitted: 2019-04-05
• Study First Posted: 2019-04-09
• Last Update Posted: 2019-04-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implant revision rate	10 years	Listing of implants status at 10 years to analyse the survival rate
Device related adverse events	5 and 10 years	Device related adverse events will be collected to monitor the safety
Radiographic assessment	5 and 10 Years	the occurrence of cement tears/fractures

Secondary Outcome Measures

Name	Time	Method
Harris Hip Score (HHS)	5 and 10 years	Harris Hip Score is a clinical evaluation which consists of a maximum of 100 points (best possible outcome) covering pain (1 item, 44 points), function (7 items 47 points total), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points total).
EuroQoL Five Dimensions Questionnaire (EQ-5D)	5 and 10 years	The EuroQoL Five Dimensions Questionnaire is a subject self-assessment of quality of life and consists of five questions covering the dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which subjects can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).

Trial Locations

Locations (2)

Novellas Healthcare; 🇧🇪 Asse, Belgium

Associatie Orthopedie Hasselt; 🇧🇪 Hasselt, Belgium