Five and Ten Year Results of the CMK21 Hip System

Smith & Nephew, Inc.100 enrolled

Overview

Five and ten year results of the CMK21 Hip system

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Osteoarthritis

Interventions

CMK21 Hip systemDEVICE

Total hip arthroplasty

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Novellas Healthcare

Asse, Belgium

Associatie Orthopedie Hasselt

Hasselt, Belgium

Outcomes

Primary Outcomes

Implant revision rate

Listing of implant status at 5 years to analyse the survival rate

Time frame: 5 years

Implant revision rate

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

Time frame: 10 years

Device related adverse events

Medical chart will be reviewed and device related events collected to monitor the safety

Time frame: 10 years

Device related adverse events

Device related adverse events will be collected to monitor the safety

Time frame: 5 and 10 years

Radiographic assessment

Radiolucent lines and radiosclerotic lines at both the bone cement and cement prosthesis interface

Time frame: 5 and 10 Years

Radiographic assessment

Position and fixation of the components

Time frame: 5 and 10 Years

Radiographic assessment

the occurrence of osteolysis

Time frame: 5 and 10 Years

Radiographic assessment

the occurrence of heterotopic bone formation

Time frame: 5 and 10 Years

Radiographic assessment

the occurrence of atrophy or hypertrophy

Time frame: 5 and 10 Years

Data from ClinicalTrials.gov

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Secondary Outcomes

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).

Time frame: 5 and 10 years

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).

Time frame: 5 and 10 years