Five and Ten Year Results of the CMK21 Hip System

Osteoarthritis Clinical Trial

— CMK21  

Official title:

Five and Ten Year Results of the CMK21 Hip System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03908151
• Other study ID #: R11008-2B
• Status: Terminated
• Start date: December 2010
• Est. completion date: October 2016

Study information

• Verified date: April 2019
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Five and ten year results of the CMK21 Hip system

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion:

• 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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• CMK21 Hip system
Total hip arthroplasty

Locations

Country	Name	City	State
Belgium	Novellas Healthcare	Asse
Belgium	Associatie Orthopedie Hasselt	Hasselt

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant revision rate	Listing of implant status at 5 years to analyse the survival rate	5 years
Primary	Implant revision rate	Listing of implants status at 10 years to analyse the survival rate	10 years
Primary	Device related adverse events	Medical chart will be reviewed and device related events collected to monitor the safety	10 years
Primary	Device related adverse events	Device related adverse events will be collected to monitor the safety	5 and 10 years
Primary	Radiographic assessment	Radiolucent lines and radiosclerotic lines at both the bone cement and cement prosthesis interface	5 and 10 Years
Primary	Radiographic assessment	Position and fixation of the components	5 and 10 Years
Primary	Radiographic assessment	the occurrence of osteolysis	5 and 10 Years
Primary	Radiographic assessment	the occurrence of heterotopic bone formation	5 and 10 Years
Primary	Radiographic assessment	the occurrence of atrophy or hypertrophy	5 and 10 Years
Primary	Radiographic assessment	the occurrence of cement tears/fractures	5 and 10 Years
Secondary	Harris Hip Score (HHS)	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).	5 and 10 years
Secondary	EuroQoL Five Dimensions Questionnaire (EQ-5D)	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).	5 and 10 years