OsteoarthritisNCT03542045
China ATTUNE® Study
An observational study of Osteoarthritis and Post-traumatic Arthritis, run by DePuy Orthopaedics at 1 site in China.
Trial summary
The study was designed as prospective, single-arm, multi-center which was intended to broadly capture all patients as the technology is adopted. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis, Post-traumatic Arthritis
- What is being tested?
- Cemented ATTUNE® Knee System
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2018to 19 Nov 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Single-arm Multicenter Study to Evaluate Clinical Performance of Cemented ATTUNE® Knee System in Primary Total Knee Arthroplasty
The study was designed as prospective, single-arm, multi-center which was intended to broadly capture all patients as the technology is adopted.
Read the 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.
- Conditions
- Osteoarthritis, Post-traumatic Arthritis
- Being tested
- Cemented ATTUNE® Knee System
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cemented ATTUNE® Knee SystemDevice
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survivorship.
To evaluate the implant survivorship of ATTUNE primary, cemented Knee system in Chinese patients using Kaplan Meier Survivorship at 2 yrs.
Measured: postoperatively 2 years.
Secondary outcomes (9)
Knee society score (KSS) 2011-surgeon portion at post-operative 2 years compared to pre-op baseline.
Questionnaire.
Measured: pre-operative and post-operative 2 years.
Knee injury and Osteoarthritis Outcome Score (KOOS) at postoperative 2 years compared to pre-op baseline.
Questionnaire.
Measured: 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.
Measured: 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.
Measured: Pre-operative baseline and post-operative 2 years.
Adverse events and serious adverse events.
Type and frequency of adverse events and serious adverse events.
Measured: Up to post-operative 2 years.
Implant survivorship.
Kaplan Meier Survivorship at 1 year.
Measured: Post-operative 1 year.
Health economy.
Patient total charges in hospital.
Measured: Post-operative 2 years.
Length of hospital stay.
Hospitalization duration for primary surgery.
Measured: Through hospitalization for primary surgery, an average of 2 weeks.
Destination status.
Home or rehabilitation department/secondary care facility/nursing facility.
Measured: At discharge of primary surgery, an average of post-operative 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start12 Apr 2018
- Primary completion19 Nov 2021
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- DePuy Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shudong Zhang, Principal investigator, Yantaishan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542045
- Sponsor's protocol ID
- DPS-201701
- Status last verified
- Apr 2022
- First submitted
- 10 Apr 2018
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-arm Multicenter Study to Evaluate Clinical Performance of Cemented ATTUNE® Knee System in Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03542045
- Acronym / sponsor ID
- DPS-201701
- Conditions
- Osteoarthritis, Post-traumatic Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- DePuy OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 31 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was designed as prospective, single-arm, multi-center which was intended to broadly capture all patients as the technology is adopted.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cemented ATTUNE® Knee SystemThis 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) | Device | – |
Primary outcome
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.
9 secondary outcomes
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.
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.
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.
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.
Adverse events and serious adverse events.
Time frame: Up to post-operative 2 years.
Implant survivorship.
Time frame: Post-operative 1 year.
Health economy.
Time frame: Post-operative 2 years.
Length of hospital stay.
Time frame: Through hospitalization for primary surgery, an average of 2 weeks.
Destination status.
Time frame: At discharge of primary surgery, an average of post-operative 7 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
Related trials for Osteoarthritis
Not yet recruiting
Study Comparing Osteoarthritis Programs
Osteoarthritis
Recruiting
Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
Knee Arthritis, Osteoarthritis
RecruitingObservational study
SVF Cellular Composition, Secretome, and Responses in Knee Osteoarthritis
Osteoarthritis, Knee
Recruiting
Pharmacist-physiotherapist Collaborative Management for Early Knee Osteoarthritis
Osteoarthritis (OA) of the Knee, Physiotherapy
Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shudong Zhang principal investigator
Yantaishan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Post-traumatic Arthritis, run by DePuy Orthopaedics at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survivorship. (time frame: postoperatively 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.