China ATTUNE® Study

NCT03542045 | Completed FDA Device

• 1 other identifier: DPS-201701
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Post-traumatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Implant survivorship.

  To evaluate the implant survivorship of ATTUNE primary, cemented Knee system in Chinese patients using Kaplan Meier Survivorship at 2 yrs.

  postoperatively 2 years.

Secondary Outcomes (9)

• Knee society score (KSS) 2011-surgeon portion at post-operative 2 years compared to pre-op baseline.

  pre-operative and post-operative 2 years.

• Knee injury and Osteoarthritis Outcome Score (KOOS) at postoperative 2 years compared to pre-op baseline.

  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.

  Pre-operative and post-operative 2 years.

• Knee society score (KSS) 2011-patient portion at post-operative 2 years compared to pre-op baseline.

  Pre-operative baseline and post-operative 2 years.

• Adverse events and serious adverse events.

  Up to post-operative 2 years.

Other Outcomes (5)

• Knee Society Score (KSS) 2011-surgeon portion at post-operative 6 weeks, 6 months and 1 year compared to pre-op baseline.

  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.

  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.

  Pre-operative baseline, post-operative 6 weeks, 6 months and 1 year.

Interventions

Cemented ATTUNE® Knee System DEVICE

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)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subjects with Subjects with Osteoarthritis (OA), post-trauma arthritis.
• Subject is male or female and between the ages of 18 and 80 years old, inclusive.
• 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.
• Subject requires unilateral knee replacement or the first knee with ATTUNE system during the study will be enrolled for bilateral knee replacement.
• Subject, or with the aid of a family member, is able to understand the Informed Consent Document and patient questionnaires.
• 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.
• 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.

You may not qualify if:

• 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.
• The Subject is a woman who is pregnant or lactating.
• 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.
• 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.
• 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.
• 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).
• The Subject requires a device not specified in the protocol or the surgeon determines that the ATTUNE Knee System is not a suitable treatment.

Sponsors & Collaborators

• DePuy Orthopaedics: lead

Study Sites (1)

Yantaishan Hospital

Yantai, Shangdong, 264001, China

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Shudong Zhang

  Yantaishan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: May 31, 2018
• Study Start: April 12, 2018
• Primary Completion: November 19, 2021
• Study Completion: November 19, 2021
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

CN (1)