Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2017-10-01
2023-12-31
Brief Summary
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We plan also to do a 5 year follow-up of the patients with RSA and PROMS.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cruciate Retaining Polyethylene (CR)
This is the standard Polyethylene articular surface
No interventions assigned to this group
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.
Medial Congruent Polyethylene (MC)
One group receives the conventional CR surface and the other the new MC articular surface
Interventions
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Medial Congruent Polyethylene (MC)
One group receives the conventional CR surface and the other the new MC articular surface
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA I-III
* BMI 18 - 35
Exclusion Criteria
* 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
* 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
50 Years
85 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Region Skane
OTHER
Responsible Party
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Principal Investigators
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Gunnar Flivik, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Dept of Orthopedics, Skåne University Hospital
Locations
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Department of Orthopedics, Skane University Hospital, Lund University
Lund, , Sweden
Countries
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Other Identifiers
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Persona RSA study_MT
Identifier Type: -
Identifier Source: org_study_id
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