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| Name | Class |
|---|---|
| Zimmer Biomet | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medial Congruent Polyethylene (MC) | Device | One group receives the conventional CR surface and the other the new MC articular surface |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiostereometry (RSA) | Measure the change in component migration over time (translation and rotation around the x-, y- and z-axis) | First postoperative day, 3 months, 1 year, 2 years and 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Computer Tomography (CT) | Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position | Preoperatively and 3 months postoperatively |
| Conventional radiography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gunnar Flivik, MD PhD | Dept of Orthopedics, Skåne University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopedics, Skane University Hospital, Lund University | Lund | 22185 | Sweden |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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|
Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position
| Preoperatively and 3 months postoperatively |
| General health questionnaire | EuroQol (EQ-5D) -standardized instrument for use of general health outcome | 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 | Preoperatively, 1, 2 and 5 years postoperatively |
| D012216 |
| Rheumatic Diseases |