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Outcome of TKA Using Customized Cutting Block Compared With Conventional Intramedullary Cutting Guide

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ClinicalTrials.gov Identifier: NCT02128464
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
Phonthakorn Panichkul, Thammasat University

Brief Summary:
Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of OA knee patients.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Procedure: Patient specific cutting guides Procedure: Standard knee cutting guides Phase 4

Detailed Description:
Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of osteoarthritic knee patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Customized Cutting Block (Visionaire™) and Conventional Total Knee Arthroplasty: A Prospective Randomized Control Trial
Study Start Date : October 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

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Arm Intervention/treatment
Active Comparator: Standard knee cutting guides
Standard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod.
Procedure: Standard knee cutting guides
Standard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod.

Active Comparator: Patient specific cutting guides
Patient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone.
Procedure: Patient specific cutting guides
Patient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone.




Primary Outcome Measures :
  1. Mechanical Axis Alignment (Absolute Value Measured in Degrees) Using 3 Feet Long Leg Films [ Time Frame: 3 Months Post-operative ]
    Femoral Valgus Angle, Tibial varus angle, Tibial slope, Femoral Flexsion/Extension angle, Implant Rotation


Secondary Outcome Measures :
  1. Intraoperative Bleeding [ Time Frame: Intra-operative ]
  2. Operative time [ Time Frame: During the procedure ]
  3. Blood volume in suction drain [ Time Frame: Post-operative Day 2 ]
  4. Hemoglobin level [ Time Frame: Post-operative day1, 2, 3 ]
  5. WOMAC score [ Time Frame: 6 weeks ]
  6. WOMAC score [ Time Frame: 3 Months ]
  7. WOMAC score [ Time Frame: 6 Months ]
  8. WOMAC score [ Time Frame: 1 year ]

Other Outcome Measures:
  1. WOMAC Score [ Time Frame: 2 years ]


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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 60-90
  • Diagnosis of osteoarthritis or rheumatoid arthritis of the knee and qualify for surgery, as indicated by one of the following:
  • Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved;
  • Correction of varus or valgus.
  • Willing to participate and return for follow-up study visits.

Exclusion Criteria:

  • Vascular insufficiency
  • Previous deep vein thrombosis and pulmonary embolism
  • Previous osteotomy
  • Previous patella fracture or surgery
  • Previous healed tibia or femur fractures
  • Previous joint replacement surgery

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): NCT02128464


Locations
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Thailand
Thammasat University Hospital.
Pathumthani, Thailand, 12120
Sponsors and Collaborators
Thammasat University
Investigators
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Principal Investigator: Phonthakorn Panichkul, MD Thammasat University

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Responsible Party: Phonthakorn Panichkul, Thammasat University
ClinicalTrials.gov Identifier: NCT02128464     History of Changes
Other Study ID Numbers: OrthoTu-02
OrthoTu-02 ( Other Identifier: Thammasat University )
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016

Keywords provided by Phonthakorn Panichkul, Thammasat University:
Knee Osteoarthritis
Total Knee Arthroplasty
Customized Cutting Block
Conventional Intramedullary Cutting Guide

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