OsteoarthritisCMK21NCT03908151
Five and Ten Year Results of the CMK21 Hip System
An observational study of Osteoarthritis, run by Smith & Nephew, Inc. at 2 sites in Belgium.
Trial summary
Five and ten year results of the CMK21 Hip system Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- CMK21 Hip system
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesBelgium
- Study dates
- Dec 2010to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
About this study
Five and ten year results of the CMK21 Hip system
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- CMK21 Hip system
- Keywords
- hip prosthesis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMK21 Hip systemDevice
Total hip arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant revision rate
Listing of implant status at 5 years to analyse the survival rate
Measured: 5 years
Implant revision rate
Listing of implants status at 10 years to analyse the survival rate
Measured: 10 years
Device related adverse events
Medical chart will be reviewed and device related events collected to monitor the safety
Measured: 10 years
Device related adverse events
Device related adverse events will be collected to monitor the safety
Measured: 5 and 10 years
Radiographic assessment
Radiolucent lines and radiosclerotic lines at both the bone cement and cement prosthesis interface
Measured: 5 and 10 Years
Radiographic assessment
Position and fixation of the components
Measured: 5 and 10 Years
Radiographic assessment
the occurrence of osteolysis
Measured: 5 and 10 Years
Radiographic assessment
the occurrence of heterotopic bone formation
Measured: 5 and 10 Years
Radiographic assessment
the occurrence of atrophy or hypertrophy
Measured: 5 and 10 Years
Radiographic assessment
the occurrence of cement tears/fractures
Measured: 5 and 10 Years
Secondary outcomes (2)
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).
Measured: 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).
Measured: 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study startDec 2010
- Primary completionAug 2016
- Study completionOct 2016
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beate Hanson, VP, PhD, Study chair, Vice President, Global Clinical Strategy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908151
- Sponsor's protocol ID
- R11008-2B
- Acronym
- CMK21
- Status last verified
- Apr 2019
- First submitted
- 26 Aug 2016
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five and Ten Year Results of the CMK21 Hip System
- ClinicalTrials.gov ID
- NCT03908151
- Acronym / sponsor ID
- CMK21 / R11008-2B
- Conditions
- Osteoarthritis
- Keywords
- hip prosthesis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMK21 Hip systemTotal hip arthroplasty | Device | – |
Primary outcome
Implant revision rate
Time frame: 5 years
Listing of implant status at 5 years to analyse the survival rate
Implant revision rate
Time frame: 10 years
Listing of implants status at 10 years to analyse the survival rate
Device related adverse events
Time frame: 10 years
Medical chart will be reviewed and device related events collected to monitor the safety
Device related adverse events
Time frame: 5 and 10 years
Device related adverse events will be collected to monitor the safety
Radiographic assessment
Time frame: 5 and 10 Years
Radiolucent lines and radiosclerotic lines at both the bone cement and cement prosthesis interface
Radiographic assessment
Time frame: 5 and 10 Years
Position and fixation of the components
Radiographic assessment
Time frame: 5 and 10 Years
the occurrence of osteolysis
Radiographic assessment
Time frame: 5 and 10 Years
the occurrence of heterotopic bone formation
Radiographic assessment
Time frame: 5 and 10 Years
the occurrence of atrophy or hypertrophy
Radiographic assessment
Time frame: 5 and 10 Years
the occurrence of cement tears/fractures
2 secondary outcomes
Harris Hip Score (HHS)
Time frame: 5 and 10 years
EuroQoL Five Dimensions Questionnaire (EQ-5D)
Time frame: 5 and 10 years
Results and safety
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beate Hanson, VP, PhD study chair
Vice President, Global Clinical Strategy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Smith & Nephew, Inc. at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant revision rate (time frame: 5 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.