OsteoarthritisNCT02663804
Total Knee Arthroplasty: Relation Between Patient Satisfaction and Implant Geometry
A study testing Total Knee Arthroplasty in people with Osteoarthritis, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
A RCT (randomized controlled trial) comparing 3 different TKA (total knee arthroplasty) implant designs and investigating the relation between patient satisfaction and the implant geometry. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Total Knee Arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2014to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female patients of all ages, scheduled for TKA
- Primary osteoarthritis of the knee joint
- post traumatic arthritis
- rheumatoid arthritis
Who cannot join
- previous TKA in same joint
- evidence of neuromuscular or neurosensory deficiency
- immunologic suppression
Trial locations and contacts
1 site in 1 country.
About this study
A RCT (randomized controlled trial) comparing 3 different TKA (total knee arthroplasty) implant designs and investigating the relation between patient satisfaction and the implant geometry.
- Conditions
- Osteoarthritis
- Being tested
- Total Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty, Patient Satisfaction, PROMs, Implant Design
- Medical subject headings
- Osteoarthritis, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ArthroplastyDevice
Also called Journey II, Smith&Nephew, Persona, Zimmer, Unity, Corin
| Study group | Role | What they receive |
|---|---|---|
| Implant design 1 | Active comparator | Journey II, BCS, Smith\&Nephew Receives: Device: Total Knee Arthroplasty |
| Implant design 2 | Active comparator | Persona, Zimmer Receives: Device: Total Knee Arthroplasty |
| Implant design 3 | Active comparator | Unity, Corin Receives: Device: Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Determining patient specific factors by use of validated questionnaires
Measured: Preop
Patient Satisfaction
Determining patient specific factors by use of validated questionnaires
Measured: 3 months postoperative
Patient Satisfaction
Determining patient specific factors by use of validated questionnaires
Measured: 6 months postoperative
Patient Satisfaction
Determining patient specific factors by use of validated questionnaires
Measured: 1 year postoperative
Patient Satisfaction
Determining patient specific factors by use of validated questionnaires
Measured: 2 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startApr 2014
- Primary completionDec 2017
- Study completionDec 2017
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 University Hospital, GhentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663804
- Sponsor's protocol ID
- EC/2014/0023
- Status last verified
- Mar 2018
- First submitted
- 7 Jan 2016
- Last updated
- 8 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Knee Arthroplasty: Relation Between Patient Satisfaction and Implant Geometry
- ClinicalTrials.gov ID
- NCT02663804
- Acronym / sponsor ID
- EC/2014/0023
- Conditions
- Osteoarthritis
- Keywords
- Total Knee Arthroplasty, Patient Satisfaction, PROMs, Implant Design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- Apr 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 26 Jan 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.
A RCT (randomized controlled trial) comparing 3 different TKA (total knee arthroplasty) implant designs and investigating the relation between patient satisfaction and the implant geometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Implant design 1 | Active comparator | Device: Total Knee ArthroplastyJourney II, BCS, Smith\&Nephew |
| Implant design 2 | Active comparator | Device: Total Knee ArthroplastyPersona, Zimmer |
| Implant design 3 | Active comparator | Device: Total Knee ArthroplastyUnity, Corin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients of all ages, scheduled for TKA
- Primary osteoarthritis of the knee joint
- post traumatic arthritis
- rheumatoid arthritis
Key exclusion criteria (3 listed)
- previous TKA in same joint
- evidence of neuromuscular or neurosensory deficiency
- immunologic suppression
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 |
|---|---|---|
| Total Knee ArthroplastyAlso: Journey II, Smith&Nephew, Persona, Zimmer, Unity, Corin | Device | Implant design 1, Implant design 2, Implant design 3 |
Primary outcome
Patient Satisfaction
Time frame: Preop
Determining patient specific factors by use of validated questionnaires
Patient Satisfaction
Time frame: 3 months postoperative
Determining patient specific factors by use of validated questionnaires
Patient Satisfaction
Time frame: 6 months postoperative
Determining patient specific factors by use of validated questionnaires
Patient Satisfaction
Time frame: 1 year postoperative
Determining patient specific factors by use of validated questionnaires
Patient Satisfaction
Time frame: 2 years postoperative
Determining patient specific factors by use of validated questionnaires
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Knee Arthroplasty in people with Osteoarthritis, run by University Hospital, Ghent 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 8 Mar 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient Satisfaction (time frame: Preop). The study lists 5 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 8 Mar 2018.