ArthroplastyNCT02713906
Materialise X-ray Knee Guides for Total Knee Arthroplasty
A study testing X-Ray Knee Guide group in people with Arthroplasty and Replacement, run by Materialise at 1 site in Belgium.
Trial summary
The purpose of this study is to assess the positioning of customized guides designed from patients X-Rays (Materialise X-Ray Knee Guides) using computed tomography in primary total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- X-Ray Knee Guide group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2015to Apr 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physically and mentally able and willing to comply with the protocol
- Be treated for a primary total knee arthroplasty
- Are fluent in Dutch or French
- Sign the Informed Consent Form
- Comply with the indications listed in the Instructions for Use
- Be able to undergo a CT scan
Who cannot join
- Fulfilling one of the contraindications mentioned in the Instructions for Use
- Pregnant
- A prisoner
- Reported to have mental illness or belonged to a vulnerable population
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Monocentric Clinical Investigation Using the Materialise X-ray Knee Guides for Total Knee Arthroplasty
The purpose of this study is to assess the positioning of customized guides designed from patients X-Rays (Materialise X-Ray Knee Guides) using computed tomography in primary total knee arthroplasty.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- X-Ray Knee Guide group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-Ray Knee Guide groupDevice
| Study group | Role | What they receive |
|---|---|---|
| X-Ray Knee Guide group | Experimental | Total knee arthroplasy using Materialise X-Ray Knee Guides Receives: Device: X-Ray Knee Guide group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between planned and achieved tibial and femoral components position as assessed by 3D imaging processing methods
Measured: 2 Months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: Investigational device not available anymore.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materialise
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Jaeken, MD, Principal investigator, AZ Heilige Familie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713906
- Sponsor's protocol ID
- SMAT007
- Status last verified
- Apr 2018
- First submitted
- 25 Sep 2015
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Monocentric Clinical Investigation Using the Materialise X-ray Knee Guides for Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02713906
- Acronym / sponsor ID
- SMAT007
- Conditions
- Arthroplasty, Replacement, Knee
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigational device not available anymore.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- MaterialiseIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 21 Mar 2016 (estimated)
- 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.
The purpose of this study is to assess the positioning of customized guides designed from patients X-Rays (Materialise X-Ray Knee Guides) using computed tomography in primary total knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| X-Ray Knee Guide group | Experimental | Device: X-Ray Knee Guide groupTotal knee arthroplasy using Materialise X-Ray Knee Guides |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Physically and mentally able and willing to comply with the protocol
- Be treated for a primary total knee arthroplasty
- Are fluent in Dutch or French
- Sign the Informed Consent Form
- Comply with the indications listed in the Instructions for Use
Key exclusion criteria (4 listed)
- Fulfilling one of the contraindications mentioned in the Instructions for Use
- Pregnant
- A prisoner
- Reported to have mental illness or belonged to a vulnerable population
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 |
|---|---|---|
| X-Ray Knee Guide group | Device | X-Ray Knee Guide group |
Primary outcome
Difference between planned and achieved tibial and femoral components position as assessed by 3D imaging processing methods
Time frame: 2 Months post-operatively
Results and safety
The study was stopped early (reason given: Investigational device not available anymore.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
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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.
Roger Jaeken, MD principal investigator
AZ Heilige Familie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing X-Ray Knee Guide group in people with Arthroplasty and Replacement, run by Materialise at 1 site 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 6 inclusion and 4 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 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: Investigational device not available anymore.). 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?
Difference between planned and achieved tibial and femoral components position as assessed by 3D imaging processing methods (time frame: 2 Months post-operatively). 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 5 Apr 2018.