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Custom Cutting Block Instrument vs Regular Instrumentation Total Knee Replacement (TKR)

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: NCT03416946
Recruitment Status : Unknown
Verified February 2018 by Dr. Thomas Turgeon, Orthopaedic Innovation Centre.
Recruitment status was:  Active, not recruiting
First Posted : January 31, 2018
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Thomas Turgeon, Orthopaedic Innovation Centre

Brief Summary:
To determine if the use of patient-specific custom cutting blocks for implantation of total knee components results in improved limb alignment and component positioning compared to regular instrumentation.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: Visionaire Other: Traditional Not Applicable

Detailed Description:
This is a randomized controlled trial. Patients will be randomized to have their knee implanted using either the patient-specific custom cutting blocks or the regular instrumentation system. Functional and radiographic outcomes will be assessed in a blinded fashion. The Smith and Nephew Legion Primary® total knee system will be used in both groups; this is an implant with a good long term track record based on the Genesis II design. All surgeons have used and are familiar with the regular instrumentation. They will be instructed in the use of the patient-specific custom cutting blocks prior to study initiation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The block randomization process will be stratified by surgeon to ensure equal distribution between the two surgical techniques.
Masking: Single (Participant)
Masking Description: Randomization will occur after enrolment and subjects will be blinded to assignment group. All subjects will be scheduled for and receive the same MRI experience. It is not possible to blind the surgeon to the surgical technique.
Primary Purpose: Treatment
Official Title: A Double-blinded, Randomized, Controlled Trial of Total Knee Replacement Using Custom Cutting Block Instrument vs Regular Instrumentation
Actual Study Start Date : December 1, 2011
Actual Primary Completion Date : May 1, 2017
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: Custom Block Instrumentation
Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system
Device: Visionaire
Custom cutting block using MRI to create patient specific instrumentations

Active Comparator: Traditional Instrumentation
Traditional cutting methods for Total Knee Replacement
Other: Traditional
Traditional cutting method




Primary Outcome Measures :
  1. Leg alignment and components position [ Time Frame: 8 Weeks ]
    Using 3 foot standing film


Secondary Outcome Measures :
  1. EuroQol (EQ) Five Dimension (5D) Survey [ Time Frame: Preoperative, 1 and 2 years ]
    Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the EQ-5D (patient reported). The score ranges from 5 to 15 with higher scores associated with higher quality of life.

  2. Oxford Knee Score [ Time Frame: Preoperative, 1 and 2 years ]
    Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the Oxford 12 scores (patient reported). The score ranges from 0 to 48 with higher scores indicating improved function and less pain.

  3. Pain Catastrophizing Scale (PCS) score [ Time Frame: Preoperative, 1 and 2 years ]
    Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the PCS (patient reported). The total score ranges from 0 to 52 with higher scores indicating greater pain catastrophizing. Sub-scales will not be used in this study.

  4. Hospital for Special Surgery Knee Replacement Expectations Survey (HSS-KRES) [ Time Frame: Preoperative, 1 and 2 years ]
    Evaluate change from preoperative baseline to 1 and 2 year post operative in patient expectations assessments using the HSS-KRES (patient reported).The score ranges from 19 to 95 with higher scores associated with higher expectations.

  5. Pain and Satisfaction [ Time Frame: Preoperative, 1 and 2 years ]
    Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the Pain and Satisfaction Visual Analog Scale (VAS). The scale is from 0 to 100, 0=no pain / not satisfied and at 100= worst pain / satisfied. (patient reported).

  6. University of California Los Angeles (UCLA) Activity Score [ Time Frame: Preoperative, 1 and 2 years ]
    Evaluate change from preoperative baseline to 1 and 2 year post operative in activity level assessments using the UCLA Activity score (patient reported). The scale ranges from 1-10 with higher values associated with more intense activities.


Other Outcome Measures:
  1. Other Measure: time [ Time Frame: Intra-operative ]
    Surgical and tourniquet time

  2. Other Measures: instrumentation [ Time Frame: Intra-operative ]
    Number of instrument pans used

  3. Length of stay (LOS) [ Time Frame: Peri-operative ]
    Length of hospital stay

  4. Other Measures: adverse events [ Time Frame: Peri-operative and intra-operative ]
    Peri-operative complications such as deep venous thrombosis, pulmonary emboli, wound complications and cardiac events.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patient is male or female ages 18 and over.
  2. Patient is having primary total knee replacement
  3. Patient is willing to sign the informed consent and to come for all study visits.

Exclusion Criteria:

  1. Deformity of the femur preventing use of the intra-medullary guide utilized in the regular instrumentation set.
  2. Necessity for the use of constrained implants. These types of implants have intra-medullary stems, therefore all bone cuts need to be referenced off intramedullary guides, making image guided bone cuts inappropriate.
  3. Patients undergoing knee replacement revision surgery. Theses types of implants also have stems, making the use of image guided bone cuts inappropriate for the same reasons.
  4. Patients scheduled for bilateral knee surgery (simultaneous or staged)

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): NCT03416946


Locations
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Canada, Manitoba
Concordia Hospital
Winnipeg, Manitoba, Canada, R2K 3S8
Sponsors and Collaborators
Orthopaedic Innovation Centre
Investigators
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Principal Investigator: Thomas Turgeon, MD MPH FRCSC Orthopaedic Innovation Centre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Thomas Turgeon, Orthopaedic Surgeon, Orthopaedic Innovation Centre
ClinicalTrials.gov Identifier: NCT03416946    
Other Study ID Numbers: HS13322
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Dr. Thomas Turgeon, Orthopaedic Innovation Centre:
Total knee replacement
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases