Five and Ten Year Results of the CMK21 Hip System (CMK21)

Five and ten year results of the CMK21 Hip system

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: 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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Belgium
  • Asse, Belgium
    • Novellas Healthcare
  • Hasselt, Belgium
    • Associatie Orthopedie Hasselt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Chair: Beate Hanson, VP, PhD, Vice President, Global Clinical Strategy

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: August 26, 2016
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 5, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: hip prosthesis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: R11008-2B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO