Study Stopped
Business Decision
Five and Ten Year Results of the CMK21 Hip System
CMK21
1 other identifier
observational
100
1 country
2
Brief Summary
Five and ten year results of the CMK21 Hip system
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2010
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 26, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedFirst Posted
Study publicly available on registry
April 9, 2019
CompletedApril 9, 2019
April 1, 2019
5.7 years
August 26, 2016
April 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Implant revision rate
Listing of implant status at 5 years to analyse the survival rate
5 years
Implant revision rate
Listing of implants status at 10 years to analyse the survival rate
10 years
Device related adverse events
Medical chart will be reviewed and device related events collected to monitor the safety
10 years
Device related adverse events
Device related adverse events will be collected to monitor the safety
5 and 10 years
Radiographic assessment
Radiolucent lines and radiosclerotic lines at both the bone cement and cement prosthesis interface
5 and 10 Years
Radiographic assessment
Position and fixation of the components
5 and 10 Years
Radiographic assessment
the occurrence of osteolysis
5 and 10 Years
Radiographic assessment
the occurrence of heterotopic bone formation
5 and 10 Years
Radiographic assessment
the occurrence of atrophy or hypertrophy
5 and 10 Years
Radiographic assessment
the occurrence of cement tears/fractures
5 and 10 Years
Secondary Outcomes (2)
Harris Hip Score (HHS)
5 and 10 years
EuroQoL Five Dimensions Questionnaire (EQ-5D)
5 and 10 years
Interventions
Total hip arthroplasty
Eligibility Criteria
The study population consists of all patients who received a CMK21 hip stem as part of a primary total hip arthroplasty between 2005 and 2007. This includes all diagnoses, all ages, male and female.
You may qualify if:
- The patients enrolled in the study were already operated at the time of the screening.
- All the patients with osteoarthritis of the hip who received CMK21 hip stem between 2005 and 2007.
- Skeletally mature patients requiring primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Novellas Healthcare
Asse, Belgium
Associatie Orthopedie Hasselt
Hasselt, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Beate Hanson, VP, PhD
Vice President, Global Clinical Strategy
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2016
First Posted
April 9, 2019
Study Start
December 1, 2010
Primary Completion
August 1, 2016
Study Completion
October 1, 2016
Last Updated
April 9, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share