An observational study in Osteoarthritis and Post-traumatic Arthritis, sponsored by DePuy Orthopaedics. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-04-14.
Sponsored by DePuy Orthopaedics (part of Johnson & Johnson) · Observational
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.
4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 120 is above the median of 100 across 803 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →DePuy Orthopaedics is the lead sponsor of 45 studies on the registry; 2 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
First submitted after DePuy Orthopaedics became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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)
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.
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.
Knee Society Score (KSS) 2011-surgeon portion at post-operative 6 weeks, 6 months and 1 year compared to pre-op baseline.
Questionnaire.
Time frame: Pre-operative baseline, post-operative 6 weeks, 6 months, and 1 year.
Knee injury and Osteoarthritis Outcome Score (KOOS) at postoperative 6 weeks, 6 months, 1 year compared to pre-op baseline.
Questionnaire.
Time frame: Pre-operative baseline, post-operative 6 weeks, 6 months and 1 year.
Euro Quality of life five Dimensions questionnaire five level (EQ5D-5L) at postoperative 6 weeks, 6 months, 1 year compared to pre-op baseline.
Questionnaire.
Time frame: Pre-operative baseline, post-operative 6 weeks, 6 months and 1 year.
Knee society score (KSS) 2011-patient portion at post-operative 6 weeks, 6 months, 1 year compared to pre-op baseline.
Questionnaire.
Time frame: Pre-operative baseline, post-operative 6 weeks, 6 months and 1 year.
Radiographic evaluation.
Radiographic evaluation at immediate post operation and 6 weeks, 1 year visit.
Time frame: Immediate post operation, post-operative 6 weeks and 1 year.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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