The study was designed as prospective, single-arm, multi-center which was intended to broadly capture all patients as the technology is adopted.
The primary objective is to evaluate the implant survivorship of ATTUNE primary, cemented Knee system in Chinese patients using Kaplan Meier Survivorship at 2 yrs. The subject population is male and female subjects who are candidates for primary, total knee arthroplasty between 18 and 80 years of age, inclusive, willing to consent with indications consistent with the Instructions for Use. A total of 120 subjects will be enrolled in this study.
Study Type
OBSERVATIONAL
Enrollment
120
This product is for total knee arthroplasty. Four implant configurations are permitted: Cruciate Retaining Fixed Bearing (CR FB), Cruciate Retaining Rotating Platform (CR RP), Posterior Stabilizing Fixed Bearing (PS FB) and Posterior Stabilizing Rotating Platform (PS RP)
Yantaishan Hospital
Yantai, Shangdong, China
Implant survivorship.
To evaluate the implant survivorship of ATTUNE primary, cemented Knee system in Chinese patients using Kaplan Meier Survivorship at 2 yrs.
Time frame: postoperatively 2 years.
Knee society score (KSS) 2011-surgeon portion at post-operative 2 years compared to pre-op baseline.
Questionnaire.
Time frame: pre-operative and post-operative 2 years.
Knee injury and Osteoarthritis Outcome Score (KOOS) at postoperative 2 years compared to pre-op baseline.
Questionnaire.
Time frame: Pre-operative baseline and post-operative 2 years.
Euro Quality of life five Dimensions questionnaire five level (EQ5D-5L) at postoperative 2 years compared to pre-op baseline.
Questionnaire.
Time frame: Pre-operative and post-operative 2 years.
Knee society score (KSS) 2011-patient portion at post-operative 2 years compared to pre-op baseline.
Questionnaire.
Time frame: Pre-operative baseline and post-operative 2 years.
Adverse events and serious adverse events.
Type and frequency of adverse events and serious adverse events.
Time frame: Up to post-operative 2 years.
Implant survivorship.
Kaplan Meier Survivorship at 1 year.
Time frame: Post-operative 1 year.
Health economy.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Patient total charges in hospital.
Time frame: Post-operative 2 years.
Length of hospital stay.
Hospitalization duration for primary surgery.
Time frame: Through hospitalization for primary surgery, an average of 2 weeks.
Destination status.
Home or rehabilitation department/secondary care facility/nursing facility.
Time frame: At discharge of primary surgery, an average of post-operative 7 days.