Clinical trial NCT03078543: Ten Year Implant Survivorship of the ANTHEM™ PS Total Knee System
Official title: A Prospective, Multicentre, Cohort Study Assessing the Safety and Efficacy of the ANTHEM™ PS Total Knee System in Patients Following a Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Arthroplasty, Replacement, Knee
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-13
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects undergoing primary total knee arthroplasty.

Brief summary: The ANTHEM™PS Total Knee System is being conducted to demonstrate non-inferiority of 10 year implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature

Detailed description: The ANTHEM PS Study is a prospective, multicentre, cohort study to collect relevant patient reported, clinical, surgical and radiological data from 143 subjects implanted with the ANTHEM™PS Knee System for degenerative joint disease in up to 6 clinical sites globally. Total study duration for study participants will be 10 years with post-operative follow-up visits planned for 6 weeks, 1 year, 2 years, 5 years, 7.5 years and 10 years. The study will evaluate the 10 year implant survivorship and the safety and outcome of the ANTHEM™PS Knee System over 10 years. This is a post-market study of the ANTHEM™PS Total Knee System.

The primary objective of the study is to demonstrate non-inferiority (8% margin) of 10 year implant survivorship of the ANTHEM™PS Total Knee System in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature.

The secondary objectives of the study are to evaluate shorter and long term safety and outcomes of the ANTHEM™ PS Total Knee System.

* Knee injury and Osteoarthritis Outcomes Score (KOOS)
* 2011 Knee Society Score (2011 KSS)
* EQ-5D - 3L
* Femoral Fit ('Perfect Fit' rate)
* Radiographic Assessment
* Revision for any reason
* Adverse Events (AEs)

Eligibility criteria: Inclusion Criteria:

1. Subject is a candidate for primary total knee arthroplasty due to degenerative joint disease
2. Subject is willing to sign and date an EC-approved consent form
3. Subject is male or female between the ages of 18 and 75 years of age
4. Subject plans to be available through ten (10) years post-operative follow-up
5. Subject agrees to follow the study protocol

Exclusion Criteria:

1. Subject would receive the ANTHEM™ Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty
2. Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty
3. Subject has a history of patellar fracture, patellectomy, patello-femoral instability
4. Subject has inflammatory arthritis
5. Subject possesses a contralateral or ipsilateral revision hip arthroplasty
6. Subject has ipsilateral hip arthritis resulting in flexion contracture
7. Subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the Investigator:

   * Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty
   * Contralateral primary total knee or unicondylar knee arthroplasty
8. Subject has an active infection or sepsis (treated or untreated)
9. Subject has presence of malignant tumor, either primary or metastatic, or benign tumor on leg with the knee to be treated
10. Subject has conditions that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes mellitus i.e. not under treatment with oral/injectable medications to control blood glucose levels, fibromyalgia, moderate to severe renal insufficiency or neuromuscular disease)
11. Subject has a chronic, contralateral lower extremity condition causing abnormal ambulation, which is not related to the knee (e.g. ankle fusion, ankle arthroplasty, previous hip fracture).
12. Subject is pregnant or plans to become pregnant during the study
13. Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study, including mental illness, mental retardation, drug or alcohol abuse
14. Subject has a BMI\>40
15. Subject is enrolled in another investigational drug, biologic, or device study
16. Subject is facing current or impending incarceration
17. Subject has an inadequate bone stock to support the device which would make the procedure unjustifiable, including but not limited to: severe osteopenia/osteoporosis or family history of severe osteoporosis/osteopenia

Primary outcomes:
measure: Ten year Anthem knee implant survivorship
timeFrame: Study participants will be followed for 10 years
Secondary outcomes:
measure: Knee injury and Osteoarthritis Outcomes Score (KOOS)
timeFrame: Participant questionnaire completed at the Baseline timepoint, 6 weeks, 1,2, 5 and 10 years
measure: 2011 Knee Society Score (2011 KSS)
timeFrame: Participant questionnaire completed at the Baseline timepoint, 6 weeks, 1,2, 5 and 10 years
measure: EQ-5D-3L
timeFrame: Participant questionnaire completed at the Baseline timepoint, 6 weeks, 1,2, 5, 7.5 and 10 years
measure: Femoral Fit ('Perfect Fit' rate)
timeFrame: Femoral Fit will be measured at surgery, assessed for an estimated 1 hour
measure: Radiographic Assessments to adequately assess the component position, prosthesis-bone interface, and the knee alignment.
timeFrame: Radiographic assessments to be conducted at Pre-operation timepoint (Baseline), post-operative (Day 1), 6 weeks, 1,2, 5, and 10 years
measure: Revision for any reason
timeFrame: Anytime during the 10 year study period
measure: Adverse Events
timeFrame: Adverse events are collected at any time during the study with formal timepoints being at surgery, 6 weeks, 1,2, 5, 7.5 and 10 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan Hospital, Institute of Orthopedics & Traumatology,
state: Beijing
city: Milan
country: Italy
facility: Instituto Clinico Sant'Ambrogio
city: Roma
country: Italy
facility: Fatebenefratelli Isola Tiberina Gemelli Hospital - Isle of Rome
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnam
city: Hwasan
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Durban
country: South Africa
facility: Westville Hospital
state: KZN
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Smith & Nephew Medical (Shanghai) Limited
name: Julian Yang
role: STUDY_DIRECTOR
References: