Clinical trial NCT03885622: Safety and Efficacy of the ANTHEM™ CR Total Knee System
Official title: A Prospective, Multicentre, Cohort Study Assessing the Safety and Efficacy of the ANTHEM™ CR Total Knee System in Patients Following a Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-inflammatory Degenerative Joint Disease
Keywords: NIDJD
ANTHEM™ CR Total Knee System
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-21
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A minimum of 153 subjects undergoing total knee arthroplasty for degenerative joint disease will be implanted with ANTHEM™ CR Total Knee System.

Brief summary: This clinical study will evaluate the short-term (1- and 2-year) and medium term (5-year) safety and performance of the ANTHEM™ CR Total Knee System in patients with non-inflammatory degenerative joint disease of the knee requiring total knee replacement. Clinical, radiographic, Health Economic Outcomes and safety outcomes will be evaluated.

Detailed description: To assess the safety and performance of the ANTHEM™ CR Total Knee System in patients with degeneration of the knee by demonstrating non-inferiority in the revision-free survival rate at 5 years compared to a literature reference rate of 96.6% (Australian Orthopaedic Association annual report 2016).

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 has posterior cruciate ligament and all collateral ligaments intact in the index joint.
4. Subject is 18 to 75 years old at time of inclusion.
5. Subject plans to be available through ten (10) years postoperative follow-up.
6. Subject agrees to follow the study protocol.
7. Subject has achieved skeletal maturity as deemed by enrolling investigator.

Exclusion Criteria:

1. Subject would receive the ANTHEM™ CR Total Knee System on the affected knee as a revision for a previously failed (TKA) or unicondylar knee arthroplasty (UKA).
2. Subject received TKA on the contralateral knee as a revision for a previously failed TKA or UKA.
3. Subject has a history of patellar fracture, patellectomy, or 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 TKA or UKA.
8. Inadequate bone stock which would make the procedure unjustifiable including but not limited to: severe osteopenia/osteoporosis or family history of severe osteoporosis/osteopenia as deemed by the enrolling investigator.
9. Subject has collateral ligament insufficiency.
10. Subject has an active infection or sepsis (treated or untreated) or previous intra-articular infections.
11. Subject has presence of malignant tumor, either primary or metastatic, or benign tumor on leg with the knee to be treated.
12. 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).
13. Subject has contralateral lower extremity condition causing abnormal ambulation (e.g. ankle fusion, ankle arthroplasty, previous hip fracture).
14. Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures.
15. 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.
16. Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1.
17. Any subject that meets the definition of a Vulnerable Subject per ISO14155:2011: individual whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate.

Primary outcomes:
measure: Non-Inferiority 10 years postoperatively
timeFrame: 10 years postoperatively
Secondary outcomes:
measure: Change in implant fixation measured by radiographic assessment
timeFrame: 6 weeks, 1 year, 2 years, and 5 years
measure: Change in bone integrity measured by radiographic assessment
timeFrame: 6 weeks, 1 year, 2 years, and 5 years
measure: Number of Adverse Events
timeFrame: 6 weeks, 1 year, 2 years, and 5 years
measure: Quality of life measured by EQ-5D-3L
timeFrame: 6 weeks, 1 year, 2 years, and 5 years
measure: Pain as measured by Knee Society Score (2011 KSS)
timeFrame: 6 weeks, 1 year, 2 years, and 5 years
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Parekhs Hospital
state: Gujarat
city: Hisar
country: India
facility: Aadhar Health Institute
state: Haryana
city: Mohali
country: India
facility: Ivy Hospital - Ivy Elite Institute of Orthopaedics
state: Punjab
city: Milano
country: Italy
facility: Istituto Clinico San Siro
city: Milan
country: Italy
facility: Instituto Clinico Sant'Ambrogio
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeonranam-do
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Korea
city: Westville
country: South Africa
facility: Westville Hospital
state: Durban
Study officials:
affiliation: Gachon University Gil Medical
name: Jae Ang Sim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ivy Hospital - Ivy Elite Institute of Orthopaedics
name: Manuj Wadhwa, M.D.
role: PRINCIPAL_INVESTIGATOR
References: