Artificial knee joint replacement operation patient
Conditions
Interventions
investigational material(s)
Generic name etc : ATTUNE PS FIXED
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : I use
Sponsors
Kamagaya General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) the patient who could get consent in an operation 2) on the back and the enough understanding which had the enough explanation in case of participation of a test and more than 20-year-old patient who could get consent by free will of the patient person himself by a document
Exclusion criteria
Exclusion criteria: 1.the patient who is planning to need bone transplantation and augmentation The patient who is planning to need 2.Lateral release The following patient said that who taboos it in 3.ATTUNE attachment document and prohibits it kyokushomatahazenshinnoshinkouseinokansenshoumatahahaichishounoarukanja.hizakansetsuwokouseishiteirukinniku,jintaiyakansetsushinkeinoketsujonadono,sujisoshikinosayousoushitsu,shinkeishikkanniyorukinnikutoshinkeinosoukansayousoushitsu,matahajunkanshougainoarukanja.kotsusoshoushou,honeshitsufuryounokanjanouchi,inpurantonoshinkinguoyobimaigureshonyadaitaikotsukokkanbunokossetsunokanouseigaaru,matahainpurantogashijisuruhonegajuubundehanaitoishigahandanshitakanja.koudonohonekessonaruihahoneishukumatahahonehenkeinoarukanja.kokkakunomijukunakanja.sharukokansetsushounokanja.pejiettoyanokanja.honpinnozaishitsu,seibunnitaishikabinshouno Patient with the medical history and patient with instability of the serious knee which happens secondarily by high disappearance of the cartilage structure or lack of the side associate ligament 4.a doctor in attendance is the patient who judged that participation in this research was unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy The gradient angle before and after X-ray evaluation: For 12 months of way later | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy The gradient angle before and after X-ray evaluation: In front of the way, in the way, the for 3 months of way back and the for 6 months of way back efficacy The amount of transfer outside the X-ray evaluation:, the outside gradient angle and the joint line change amount In front of the way, in the way, the for 3 months of way back, the for 6 months of way back and the for 12 months of way back safety efficacy A questionnaire survey: Knee joint JOA score, Knee society score, JKOM score and safety In front of the way, in the way, the for 3 months of way back, the for 6 months of way back and the for 12 months of way back | — |
Countries
Japan
Outcome results
None listed