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Trial record 6 of 34 for:    "Osteoarthritis" | ( Map: Japan )

Vanguard TKA With KneeAlign 2 and Without KneeAlign 2

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ClinicalTrials.gov Identifier: NCT02695329
Recruitment Status : Completed
First Posted : March 1, 2016
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms of precise implant alignment by demonstrating that KneeAlign 2 provides better tibial alignment compared to conventional instruments

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: KneeAlign 2 Not Applicable

Detailed Description:
Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms of precise implant alignment by demonstrating that KneeAlign 2 provides better tibial alignment compared to conventional instruments.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Study Comparing Vanguard With KneeAlign2 Navigational System Versus Vanguard Conventional
Actual Study Start Date : May 24, 2016
Actual Primary Completion Date : October 3, 2018
Actual Study Completion Date : October 26, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Vanguard with KneeAlign 2
Having total knee arthroplasty surgery with the use of a navigation system KneeAlign 2.
Device: KneeAlign 2
Patients suffering non-severe varus deformity 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: KneeAlign2

No Intervention: Vanguard without KneeAlign 2
Having total knee arthroplasty surgery with the use of conventional surgical instruments, and without a navigation system KneeAlign 2.



Primary Outcome Measures :
  1. Proportion of subjects that have alignment within 2 degrees from neutral on tibia [ Time Frame: Postoperative 6 months ]
    Proportion of subjects that have tibial alignment within 2 degrees from neutral and compare the accuracy of tibial component alignment between two groups.


Secondary Outcome Measures :
  1. Tibial posterior slope alignment [ Time Frame: Postoperative 6 months ]
    Deviation of tibial posterior slope angle from preoperative planned angle

  2. Femoral varus/valgus angle [ Time Frame: Postoperative 6 months ]
    Deviation of femoral valus/valgus angle from preoperative planned angle

  3. Collection of adverse events and adverse device effects [ Time Frame: Intra-operative and Post-operative 6 months ]
    Collection of adverse events and adverse device effects observed



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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:

  • Knee (either unilateral or bilateral) Osteoarthritis (varus deformity only)
  • Subjects willing to return for follow-up evaluations

Exclusion Criteria:

  • Knee degenerative diseases other than Knee Osteoarthritis (such as necrosis / Rheumatoid Arthritis)
  • Severe OA deformation (FTA: >185 degrees or <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 disease on the affected side
  • 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): NCT02695329


Locations
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Japan
Osaka City University
Osaka, Japan, 558-0022
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Principal Investigator: Yukihide Minoda Osaka City University
  Study Documents (Full-Text)

Documents provided by Zimmer Biomet:

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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT02695329     History of Changes
Other Study ID Numbers: ORTHO.CR.GK53
First Posted: March 1, 2016    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Zimmer Biomet:
navigation system
palm-sized
total knee arthroplasty

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