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Safety and Efficacy of the ANTHEM™ CR Total Knee System (Anthem CR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885622
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc. ( Smith & Nephew Pte Ltd )

Study Description
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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.

Condition or disease Intervention/treatment
Non-inflammatory Degenerative Joint Disease Device: ANTHEM™ CR Total Knee System

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).
Study Design
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Study Type : Observational
Estimated Enrollment : 118 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : November 23, 2018
Estimated Primary Completion Date : March 1, 2025
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Joint Disorders

Groups and Cohorts
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Intervention Details:
  • Device: ANTHEM™ CR Total Knee System
    The ANTHEM CR Total Knee System is a CE marked device. It is a cruciate retaining (CR) total knee system. It is intended to be used in patients for primary total knee replacement surgery where the posterior cruciate ligament and collateral ligaments remain intact. It is a comprehensive system which allows surgeons to address simple to complex knee arthroplasties.

Outcome Measures
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Primary Outcome Measures :
  1. Implant survival 5 years postoperatively [ Time Frame: 5 years postoperatively ]

Secondary Outcome Measures :
  1. Change in implant fixation measured by radiographic assessment [ Time Frame: 6 weeks, 1 year, 2 years, and 5 years ]
    based on comparison of antero posterior and lateral radiographs

  2. Change in bone integrity measured by radiographic assessment [ Time Frame: 6 weeks, 1 year, 2 years, and 5 years ]
    based on comparison of antero-posterior and lateral radiographs

  3. Number of Adverse Events [ Time Frame: 6 weeks, 1 year, 2 years, and 5 years ]
    Number and frequency of all types adverse events

  4. Quality of life measured by EQ-5D-3L [ Time Frame: 6 weeks, 1 year, 2 years, and 5 years ]
    The EQ-5D-3L will be collected at each follow up visit. It consists of two pages - the EQ-5D descriptive system (page one) and the EQ visual analogue scale (EQ VAS) (page two). The descriptive system consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses.

  5. Pain as measured by Knee Society Score (2011 KSS) [ Time Frame: 6 weeks, 1 year, 2 years, and 5 years ]
    This validated tool that combines an objective physician-derived component with a subjective subject-derived component. The objective section rates alignment, instability, joint motion and symptoms.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A minimum of 118 subjects undergoing total knee arthroplasty for degenerative joint disease will be implanted with ANTHEM™ CR Total Knee System.
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 five (5) 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885622


Contacts
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Contact: Marie-Christine Mallaroni +33 (0)6 77 64 03 41 mariechristine.mallaroni@smith-nephew.com

Locations
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India
Parekhs Hospital Terminated
Ahmedabad, Gujarat, India, 380015
Aadhar Health Institute Recruiting
Hisar, Haryana, India, 125001
Contact: Amit Yadav       amity1516@gmail.com   
Contact: Ravi Jaglan    +91 09896650539    rveejaglan@gmail.com   
Principal Investigator: Vikram Jain         
Sub-Investigator: Sartaj Gil         
Ivy Hospital - Ivy Elite Institute of Orthopaedics Recruiting
Mohali, Punjab, India, 160071
Contact: Jitendra Khatri    +91-9814104345    jitendra22khatri@gmail.com   
Contact: Abhijit Katyarmal    0172-7170000    abhijit.chandigarh@gmail.com   
Principal Investigator: Manuj Wadhwa, M.D.         
Sub-Investigator: Ritesh Khokhar         
Italy
Instituto Clinico Sant'Ambrogio Not yet recruiting
Milan, Italy, 20149
Contact: Bruno Violante Violante    2.331271    violante.b@gmaiI.com   
Principal Investigator: Bruno Violante Violante         
Korea, Republic of
Chonnam National University Hwasun Hospital Recruiting
Hwasun, Jeonranam-do, Korea, Republic of, 58128
Contact: Young-Ye Park    +82-61-379-7892    dadosea251@daum.net   
Principal Investigator: Jong-Keun Seon         
Sub-Investigator: Seung Min Na         
Sub-Investigator: Ik-Sun Choi         
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Korea, Republic of, 21565
Contact: Hee Keun Kang    +32-82-460-3384    happy@gilhospital.com   
Contact: SooJeong Lee    +82-32-460-3213    sjlee@gilmdc.com   
Principal Investigator: Jae Ang Sim, M.D.         
Sub-Investigator: Hyuk Min Kwon         
Sub-Investigator: Ji Hyeon Park         
Sponsors and Collaborators
Smith & Nephew Pte Ltd
Investigators
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Principal Investigator: Jae Ang Sim, M.D. Gachon University Gil Medical
Principal Investigator: Manuj Wadhwa, M.D. Ivy Hospital - Ivy Elite Institute of Orthopaedics
More Information
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Responsible Party: Smith & Nephew Pte Ltd
ClinicalTrials.gov Identifier: NCT03885622    
Other Study ID Numbers: 17-4065-07
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Smith & Nephew, Inc. ( Smith & Nephew Pte Ltd ):
NIDJD
ANTHEM™ CR Total Knee System
Additional relevant MeSH terms:
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Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases