China ATTUNE® Study

• ClinicalTrials.gov Identifier: NCT03542045
• Recruitment Status: Active, not recruiting
• First Posted: May 31, 2018
• Last Update Posted: December 27, 2021
• Sponsor: DePuy Orthopaedics
• Information provided by (Responsible Party): DePuy Orthopaedics

Study Description

Brief Summary:

The study was designed as prospective, single-arm, multi-center which was intended to broadly capture all patients as the technology is adopted.

Condition or disease	Intervention/treatment
Osteoarthritis; Post-traumatic Arthritis	Device: Cemented ATTUNE® Knee System

Detailed Description:

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 2 Years
• Official Title: A Prospective Single-arm Multicenter Study to Evaluate Clinical Performance of Cemented ATTUNE® Knee System in Primary Total Knee Arthroplasty
• Actual Study Start Date: April 12, 2018
• Estimated Primary Completion Date: March 1, 2022
• Estimated Study Completion Date: March 1, 2022

Groups and Cohorts

Intervention Details:

• Device: Cemented ATTUNE® Knee System
  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)

Outcome Measures

Primary Outcome Measures :

1. Implant survivorship. [ Time Frame: postoperatively 2 years. ]
   To evaluate the implant survivorship of ATTUNE primary, cemented Knee system in Chinese patients using Kaplan Meier Survivorship at 2 yrs.

Secondary Outcome Measures :

1. Knee society score (KSS) 2011-surgeon portion at post-operative 2 years compared to pre-op baseline. [ Time Frame: pre-operative and post-operative 2 years. ]
   Questionnaire.
2. Knee injury and Osteoarthritis Outcome Score (KOOS) at postoperative 2 years compared to pre-op baseline. [ Time Frame: Pre-operative baseline and post-operative 2 years. ]
   Questionnaire.
3. Euro Quality of life five Dimensions questionnaire five level (EQ5D-5L) at postoperative 2 years compared to pre-op baseline. [ Time Frame: Pre-operative and post-operative 2 years. ]
   Questionnaire.
4. Knee society score (KSS) 2011-patient portion at post-operative 2 years compared to pre-op baseline. [ Time Frame: Pre-operative baseline and post-operative 2 years. ]
   Questionnaire.
5. Adverse events and serious adverse events. [ Time Frame: Up to post-operative 2 years. ]
   Type and frequency of adverse events and serious adverse events.
6. Implant survivorship. [ Time Frame: Post-operative 1 year. ]
   Kaplan Meier Survivorship at 1 year.
7. Health economy. [ Time Frame: Post-operative 2 years. ]
   Patient total charges in hospital.
8. Length of hospital stay. [ Time Frame: Through hospitalization for primary surgery, an average of 2 weeks. ]
   Hospitalization duration for primary surgery.
9. Destination status. [ Time Frame: At discharge of primary surgery, an average of post-operative 7 days. ]
   Home or rehabilitation department/secondary care facility/nursing facility.

Other Outcome Measures:

1. Knee Society Score (KSS) 2011-surgeon portion at post-operative 6 weeks, 6 months and 1 year compared to pre-op baseline. [ Time Frame: Pre-operative baseline, post-operative 6 weeks, 6 months, and 1 year. ]
   Questionnaire.
2. Knee injury and Osteoarthritis Outcome Score (KOOS) at postoperative 6 weeks, 6 months, 1 year compared to pre-op baseline. [ Time Frame: Pre-operative baseline, post-operative 6 weeks, 6 months and 1 year. ]
   Questionnaire.
3. Euro Quality of life five Dimensions questionnaire five level (EQ5D-5L) at postoperative 6 weeks, 6 months, 1 year compared to pre-op baseline. [ Time Frame: Pre-operative baseline, post-operative 6 weeks, 6 months and 1 year. ]
   Questionnaire.
4. Knee society score (KSS) 2011-patient portion at post-operative 6 weeks, 6 months, 1 year compared to pre-op baseline. [ Time Frame: Pre-operative baseline, post-operative 6 weeks, 6 months and 1 year. ]
   Questionnaire.
5. Radiographic evaluation. [ Time Frame: Immediate post operation, post-operative 6 weeks and 1 year. ]
   Radiographic evaluation at immediate post operation and 6 weeks, 1 year visit.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

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.

Criteria

Inclusion Criteria:

1. Subjects with Subjects with Osteoarthritis (OA), post-trauma arthritis.
2. Subject is male or female and between the ages of 18 and 80 years old, inclusive.
3. Subject requires a primary total knee replacement with or without un-resurfaced patella and is considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol.
4. Subject requires unilateral knee replacement or the first knee with ATTUNE system during the study will be enrolled for bilateral knee replacement.
5. Subject, or with the aid of a family member, is able to understand the Informed Consent Document and patient questionnaires.
6. Subject, with the aid of a family member as needed, has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to the Sponsor.
7. Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures.

Exclusion Criteria:

1. The Subject has, in the opinion of the Investigator, an existing condition that would compromise their participation and follow-up in this study, e.g. living in distant areas or having difficulty to return to the site, incooperative to surgeons' medical instructions and suggestions.
2. The Subject is a woman who is pregnant or lactating.
3. The Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect follow-up care or treatment outcomes.
4. The Subject has participated in a clinical investigation with an investigational product in the last 3 months that could impact/affect the outcome of the current procedure and follow-ups judged by the investigator.
5. The Subject has previous prosthetic knee replacement (any type including unicompartmental, total knee arthroplasty, patellofemoral arthroplasty or ipsilateral Upper Tibial Osteotomy (UTO)/ High Tibial Osteotomy (HTO)) of the affected knee or a previous patellectomy.
6. Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot disease, avascular necrosis).
7. The Subject requires a device not specified in the protocol or the surgeon determines that the ATTUNE Knee System is not a suitable treatment.

Contacts and Locations

Locations

China, Shangdong

Yantaishan Hospital

Yantai, Shangdong, China, 264001

Sponsors and Collaborators

DePuy Orthopaedics

Investigators

• Principal Investigator: Shudong Zhang; Yantaishan Hospital

More Information

Additional Information:

• Responsible Party: DePuy Orthopaedics
• ClinicalTrials.gov Identifier: NCT03542045
• Other Study ID Numbers: DPS-201701
• First Posted: May 31, 2018
• Last Update Posted: December 27, 2021
• Last Verified: December 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases