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Completed

NCT Number: NCT03416946

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Concordia Hospital

Winnipeg, Manitoba, R2K 3S8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Deformity of the femur preventing use of the intra-medullary guide utilized in the regular instrumentation set.
  • 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.
  • 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.
  • Patients scheduled for bilateral knee surgery (simultaneous or staged)

Treatment and study plan

Visionaire

Device

Custom cutting block using MRI to create patient specific instrumentations

Traditional

Other

Traditional cutting method

Primary outcomes

  1. Radiographic Alignment

    Time frame: 8 Weeks

    Using 3 foot standing film

  2. Number of HKA Angle Outliers

    Time frame: 8 Weeks

    The angle formed between the mechanical axes of the femur and tibia create the hip-knee-ankle (HKA) angle.

Secondary outcomes

  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 digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state, this health state is range from 0 to 1.0. Higher scores indicate improved quality of life within each dimension.

  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. Hip Pain

    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 Visual Analog Scale (VAS). The scale is from 0 to 100, 0=no pain and at 100= worst pain. (patient reported).

  5. 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.

  6. Patient 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 Satisfaction Visual Analog Scale (VAS). The scale is from 0 to 100, 0=Not Satisfied and at 100=Satisfied. (patient reported).

Other outcomes

  1. Other Measure: Time

    Time frame: Intra-operative

    Surgical and tourniquet time

  2. Blood Loss

    Time frame: Intra-operative

    Blood loss during surgery >100ml (n)

  3. Length of Stay (LOS)

    Time frame: Peri-operative

    Length of hospital stay

  4. Other Measures: Adverse Events

    Time frame: Peri-operative, intra-operative and post-operative

    Peri-operative complications such as deep venous thrombosis, pulmonary emboli, wound complications and cardiac events.

    Post-operative complication such as infection, loosening, etc.

Sponsors and collaborators

Lead sponsor

Orthopaedic Innovation Centre

Other

Registry information

Official study title

A Double-blinded, Randomized, Controlled Trial of Total Knee Replacement Using Custom Cutting Block Instrument vs Regular Instrumentation

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jan 31, 2018
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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