Ten Year Implant Survivorship of the ANTHEM™ PS Total Knee System (ANTHEM PS)

Smith & Nephew

Status: Active, not recruiting

Conditions: Arthroplasty, Replacement, Knee

Treatments: Device: ANTHEM™ PS Total Knee System implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT03078543

14-4065-09

OREM-ANTHEM-PMCFU (Other Identifier)

Details and patient eligibility

About

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

Full 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)

Enrollment: 148 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

148 participants in 1 patient group

ANTHEM™ PS Total Knee System implant

Other group

Description:

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

Treatment:

Device: ANTHEM™ PS Total Knee System implant