A Trial of Mechanical Axis vs Kinematic Alignment in Total Knee Replacement
NCT ID: NCT02527148
Last Updated: 2025-05-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2011-08-04
2018-12-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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OtisMed® ShapeMatch® with Triathlon
Participants randomised to the Intervention Group will undergo Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology with the goal of kinematic alignment (re-aligning the limb to its pre-disease kinematic alignment).
Total Knee Replacement
Stryker Triathlon® Total Knee System
Prosthetic components to be implanted including
* Triathlon® Cruciate Retaining (CR) Total Knee System (cemented), including Femoral Component and Primary Tibial Baseplate;
* Triathlon® Cruciate Substituting (CS) X3® polyethylene insert;
* Triathlon® X3 Patella (asymmetric) - treated selectively by surgeon.
OtisMed® ShapeMatch® Technology
The appropriate Stryker ShapeMatch® Cutting Guides will be used to guide the surgeons bone resections. The surgeon will implant the knee prostheses following the surgical protocol for Triathlon® Knee System with OtisMed® ShapeMatch® Technology
Stryker Precision Knee Navigation
Participants randomised to the Control Group will undergo Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation with the goal of neutral alignment to the mechanical axis. This is the standard method for TKR with Triathlon® Knee System and this group will serve as a control reference for the intervention group.
Stryker Precision Knee Navigation
Stryker PrecisioN Knee (4.0) Navigation System, comprising of computer hardware and software and associated instrumentation, will be used for intra-operative alignment and orientation of implant. Navigation trackers will be secured to the femur and tibia and registration of the limb will be undertaken according to the PrecisioN Knee System surgical technique.Femoral and tibial resections, followed by device implantation, will be performed according to the Triathlon Knee System Surgical Protocol.
Total Knee Replacement
Stryker Triathlon® Total Knee System
Prosthetic components to be implanted including
* Triathlon® Cruciate Retaining (CR) Total Knee System (cemented), including Femoral Component and Primary Tibial Baseplate;
* Triathlon® Cruciate Substituting (CS) X3® polyethylene insert;
* Triathlon® X3 Patella (asymmetric) - treated selectively by surgeon.
Interventions
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Stryker Precision Knee Navigation
Stryker PrecisioN Knee (4.0) Navigation System, comprising of computer hardware and software and associated instrumentation, will be used for intra-operative alignment and orientation of implant. Navigation trackers will be secured to the femur and tibia and registration of the limb will be undertaken according to the PrecisioN Knee System surgical technique.Femoral and tibial resections, followed by device implantation, will be performed according to the Triathlon Knee System Surgical Protocol.
Total Knee Replacement
Stryker Triathlon® Total Knee System
Prosthetic components to be implanted including
* Triathlon® Cruciate Retaining (CR) Total Knee System (cemented), including Femoral Component and Primary Tibial Baseplate;
* Triathlon® Cruciate Substituting (CS) X3® polyethylene insert;
* Triathlon® X3 Patella (asymmetric) - treated selectively by surgeon.
OtisMed® ShapeMatch® Technology
The appropriate Stryker ShapeMatch® Cutting Guides will be used to guide the surgeons bone resections. The surgeon will implant the knee prostheses following the surgical protocol for Triathlon® Knee System with OtisMed® ShapeMatch® Technology
Eligibility Criteria
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Inclusion Criteria
* The patient requires a primary total knee replacement and is indicated for computer-assisted surgery.
* Patient is deemed appropriate for a cruciate retaining knee replacement.
* The patient has a primary diagnosis of osteoarthritis (OA).
* The patient has intact collateral ligaments.
* The patient is able to undergo MRI scanning of the affected limb.
* The patient has signed the study specific, ethics-approved, Informed Consent document.
* The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.
Exclusion Criteria
* Patient has had a previous osteotomy around the knee.
* The patient is morbidly obese (BMI ≥ 40).
* The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
* The patient has a varus/valgus malalignment ≥ 15° (relative to mechanical axis).
* The patient has a fixed flexion deformity ≥ 15°.
* The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
* The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
* The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
* Patient has a cognitive impairment, an intellectual disability or a mental illness.
* The patient is pregnant.
* The patient has metal hardware present in the region of the hip, knee or ankle (as this is known to create geometrical distortion in the region of the implant).
* The patient has any known contraindications for undergoing assessment by MRI (e.g. ferrous implants, metallic clips, magnetically activated implanted devices such as cardiac pacemakers, etc).
40 Years
80 Years
ALL
No
Sponsors
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Stryker South Pacific
INDUSTRY
Responsible Party
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ShapeNZRCT-10
Identifier Type: -
Identifier Source: org_study_id
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