Osteoarthritis, KneeNCT03494348
RSA Study of Persona TKA With CR vs MC Polyethylene
A study testing Medial Congruent Polyethylene (MC) in people with Osteoarthritis, Knee, run by Region Skane at 1 site in Sweden.
Trial summary
The aim of this study is to evaluate, over a 2 year period, the migration pattern, function and the possibility of anatomical reconstruction of a relatively new total knee arthroplasty (TKA) concept, the Persona. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Medial Congruent Polyethylene (MC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2017to Dec 2023
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis of the knee necessitating knee replacement
- ASA I-III
- BMI 18 - 35
Who cannot join
- Joint sepsis in history
- immunosuppresive drugs last 5 years
- Rheumatoid arthritis
- Severe osteoporosis or other metabolic bone diseases
- Neuromuscular diseases
- Personal disorders suspected of limiting rehab and completion of the trial period
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- Previous osteotomy of affected limb
- Intra-articular knee fracture of affected limb
- Peroperative fracture
- Severe deformity of affected joint in need of augmentation or excessive release
- Obvious need for more constrained knee than CR
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Orthopedics, Skane University Hospital, Lund University
Lund, 22185
About this study
Official title: Aspects of Alignment, Function, and Migration Behaviour in Two Conceptually Different Articular Surface Designs in the Cruciate Retaining Version of the Cemented Persona Knee System - A Randomized Study Evaluated by RSA and CT Analysis
The aim of this study is to evaluate, over a 2 year period, the migration pattern, function and the possibility of anatomical reconstruction of a relatively new total knee arthroplasty (TKA) concept, the Persona. Sixty patients will be randomized into 2 groups of 30 patients each, with one group receiving the Persona TKA with a conventional Cruciate Retaining (CR) polyethylene articular surface and the other group with a newly developed Medial Congruent (MC) articular surface. Patients will be followed up with Radiostereometry (RSA), conventional radiography, outcome questionnaires, clinical evaluation and Computer Tomography (CT). The migration pattern of the components will be evaluated as well as the degree of anatomical reconstruction and clinical result.
We plan also to do a 5 year follow-up of the patients with RSA and PROMS.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Medial Congruent Polyethylene (MC)
- Keywords
- Radiostereometry (RSA), Total Knee Arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medial Congruent Polyethylene (MC)Device
Also called MC
One group receives the conventional CR surface and the other the new MC articular surface
| Study group | Role | What they receive |
|---|---|---|
| Cruciate Retaining Polyethylene (CR) | No intervention | This is the standard Polyethylene articular surface |
| Medial Congruent Polyethylene (MC) | Active comparator | The intervention here will be the MC articular surface. This is the new Polyethylene articular surface with a more congruent medial side and a more flat lateral side which should better resemble natural anatomy. Receives: Device: Medial Congruent Polyethylene (MC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiostereometry (RSA)
Measure the change in component migration over time (translation and rotation around the x-, y- and z-axis)
Measured: First postoperative day, 3 months, 1 year, 2 years and 5 years
Secondary outcomes (4)
Computer Tomography (CT)
Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position
Measured: Preoperatively and 3 months postoperatively
Conventional radiography
Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position
Measured: Preoperatively and 3 months postoperatively
General health questionnaire
EuroQol (EQ-5D) -standardized instrument for use of general health outcome
Measured: Preoperatively, 1, 2 and 5 years postoperatively
Knee specific health questionnaire
Knee disability and Osteoarthritis Outcome Score (KOOS) - this is a knee specific questionnaire measuring patients knee function and pain situation
Measured: Preoperatively, 1, 2 and 5 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start1 Oct 2017
- Primary completion30 Oct 2020
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Sponsor
- Investigators
- Gunnar Flivik, MD PhD, Principal investigator, Dept of Orthopedics, Skåne University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494348
- Sponsor's protocol ID
- Persona RSA study_MT
- Status last verified
- Nov 2022
- First submitted
- 3 Apr 2018
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspects of Alignment, Function, and Migration Behaviour in Two Conceptually Different Articular Surface Designs in the Cruciate Retaining Version of the Cemented Persona Knee System - A Randomized Study Evaluated by RSA and CT Analysis
- ClinicalTrials.gov ID
- NCT03494348
- Acronym / sponsor ID
- Persona RSA study_MT
- Conditions
- Osteoarthritis, Knee
- Keywords
- Radiostereometry (RSA), Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 11 Apr 2018 (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.
The aim of this study is to evaluate, over a 2 year period, the migration pattern, function and the possibility of anatomical reconstruction of a relatively new total knee arthroplasty (TKA) concept, the Persona. Sixty patients will be randomized into 2 groups of 30 patients each, with one group receiving the Persona TKA with a conventional Cruciate Retaining (CR) polyethylene articular surface and the other group with a newly developed Medial Congruent (MC) articular surface. Patients will be followed up with Radiostereometry (RSA), conventional radiography, outcome questionnaires, clinical evaluation and Computer Tomography (CT). The migration pattern of the components will be evaluated as well as the degree of anatomical reconstruction and clinical result.
We plan also to do a 5 year follow-up of the patients with RSA and PROMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cruciate Retaining Polyethylene (CR) | No intervention | –This is the standard Polyethylene articular surface |
| Medial Congruent Polyethylene (MC) | Active comparator | Device: Medial Congruent Polyethylene (MC)The intervention here will be the MC articular surface. This is the new Polyethylene articular surface with a more congruent medial side and a more flat lateral side which should better resemble natural anatomy. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Osteoarthritis of the knee necessitating knee replacement
- ASA I-III
- BMI 18 - 35
Key exclusion criteria (11 listed)
- Joint sepsis in history
- immunosuppresive drugs last 5 years
- Rheumatoid arthritis
- Severe osteoporosis or other metabolic bone diseases
- Neuromuscular diseases
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 |
|---|---|---|
| Medial Congruent Polyethylene (MC)Also: MCOne group receives the conventional CR surface and the other the new MC articular surface | Device | Medial Congruent Polyethylene (MC) |
Primary outcome
Radiostereometry (RSA)
Time frame: First postoperative day, 3 months, 1 year, 2 years and 5 years
Measure the change in component migration over time (translation and rotation around the x-, y- and z-axis)
4 secondary outcomes
Computer Tomography (CT)
Time frame: Preoperatively and 3 months postoperatively
Conventional radiography
Time frame: Preoperatively and 3 months postoperatively
General health questionnaire
Time frame: Preoperatively, 1, 2 and 5 years postoperatively
Knee specific health questionnaire
Time frame: Preoperatively, 1, 2 and 5 years postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
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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.
Gunnar Flivik, MD PhD principal investigator
Dept of Orthopedics, Skåne University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medial Congruent Polyethylene (MC) in people with Osteoarthritis, Knee, run by Region Skane at 1 site in Sweden.
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 11 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: status not confirmed, as of the sponsor's last update on 29 Nov 2022. 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 Sweden. 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?
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?
Radiostereometry (RSA) (time frame: First postoperative day, 3 months, 1 year, 2 years and 5 years). 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 29 Nov 2022.