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Trial record 10 of 34 for:    "Osteoarthritis" | ( Map: Japan )

Persona TKA With iASSIST Knee System and iASSIST Knee System

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03227692
Recruitment Status : Active, not recruiting
First Posted : July 24, 2017
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
The purpose of this study is to compare the accuracy of knee component alignment between patients operated with iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Control group) using the same implant system.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: Persona Knee System Procedure: Total Knee Arthroplasty Device: iAssist Knee Not Applicable

Detailed Description:

Objective: To compare the accuracy of knee component alignment between patients operated with iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Control group) using the same implant system.

Endpoint: Primary: The alignment accuracy of the knee femoral and tibial components at 6 months for the investigational group compared to the control group.

Secondary:Health Status after TKA, Operating Room efficiency and Complication rate after TKA for the investigational group compared to the control group.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: At surgery, intervention group using iASSIST Knee system. At surgery, conventional group not using iASSIST Knee system.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Persona TKA with iASSIST Knee system (Investigational group) or Persona TKA with conventional instrumentation (Control group). The randomization scheme is based on equal numbers per group. The randomization will occur via a random number generator (computer) using blocked randomization procedure. The PI or his/her team does not have influence on the randomization scheme. Sealed opaque envelopes, which will be prepared based on predetermined randomization assignment, will be provided to each study site before study initiation.
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Study Comparing iASSIST Knee System Versus Conventional Instrumentation
Actual Study Start Date : August 18, 2017
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Persona with iASSIST Knee
Having total knee arthroplasty (Persona Knee System) surgery with the use of a navigation system iASSIST Knee.
Device: Persona Knee System
Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.
Other Name: Persona Knee

Procedure: Total Knee Arthroplasty
Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.
Other Name: TKA

Device: iAssist Knee
Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.

Active Comparator: Persona without iASSIST Knee
Having total knee arthroplasty surgery (Persona Knee System) with the use of conventional surgical instruments, and without a navigation system iASSIST Knee.
Device: Persona Knee System
Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.
Other Name: Persona Knee

Procedure: Total Knee Arthroplasty
Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.
Other Name: TKA




Primary Outcome Measures :
  1. Alignment accuracy of the knee femoral and tibial components [ Time Frame: Postoperative 6 months ]
    The alignment accuracy of the knee femoral and tibial components at 6 months for the investigational group compared to the control group.


Secondary Outcome Measures :
  1. EQ-5D [ Time Frame: Preoperative ]
    Health Status assessed with the EQ-5D form

  2. Surgery time [ Time Frame: Intraoperative ]
    Surgery time from skin incision to closure

  3. Safety Information: Any adverse events (including device related, non-device related, procedure related, nonprocedure related) [ Time Frame: Intraoperative ]
    Any adverse events (including device related, non-device related, procedure related, non-procedure related)

  4. Safety Information: Any adverse events (including device related, non-device related, procedure related, nonprocedure related) [ Time Frame: Up to 6 months ]
    Any adverse events (including device related, non-device related, procedure related, non-procedure related)

  5. Number of instrument trays used [ Time Frame: Intraoperative ]
    Number of instrument trays used



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

In order to be eligible to participate in this study, a patient must meet all of the following criteria.

  • Knee (either unilateral or bilateral) osteoarthritis (varus deformity only)
  • Male or female
  • At least 20 years of age
  • Patients willing to return for follow-up evaluations.

Study Specific Requirements for Principal Investigator/Site

  • Principal Investigator (PI) must have experience of at least 5 TKAs of iASSIST Knee with Persona and Persona conventional instrument system before any study specific activities.
  • Site has sufficient resources to take limb CT scanning at 6 months follow-up visit.

Exclusion Criteria:

Absolute contraindications include:

  • Knee degenerative diseases other than knee osteoarthritis (such as necrosis/rheumatoid arthritis)
  • Too severe OA deformation (FTA: > 190 degrees/< 175 degrees)
  • Active infection (or within 6 weeks after infection)
  • Sepsis
  • Osteomyelitis
  • Any type of implant is inserted in the affected side of lower extremity
  • Hip and/or foot disease on the affected side

Additional contraindications include:

  • Uncooperative patient or patient with neurologic disorders who are incapable of following directions
  • Diagnosed osteoporosis or osteomalacia
  • Metabolic disorders which may impair bone formation
  • Distant foci of infections which may spread to the implant site
  • Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
  • Vascular insufficiency, muscular atrophy or neuromuscular disease.

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): NCT03227692


Locations
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Japan
Sumitomo Hopital
Ōsaka, Osaka, Japan, 530-0005
Japanese Red Cross Medical Center
Shibuya, Tokyo, Japan, 150-8935
Yamaguchi Prefectural Grand Medical Center
Hōfu, Yamaguchi, Japan, 747-8511
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Principal Investigator: Toshihiro Ohdera, M.D. Fukuoka Orthopaedic Hospital

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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03227692     History of Changes
Other Study ID Numbers: K.CR.I.AP.16.39
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases