A Trial of Mechanical Axis vs Kinematic Alignment in Total Knee Replacement

Stryker South Pacific100 enrolled

Overview

This is a prospective, randomized, longitudinal study of the clinical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement. In this study ShapeMatch® cutting guides will be compared to the conventional approach.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Arthroplasties Knee Replacement

Interventions

OtisMed® ShapeMatch® TechnologyDEVICE

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 NavigationDEVICE

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patient is a male or non-pregnant female between the ages of 40-80 years. * 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: * The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint. * 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).

Outcomes

Primary Outcomes

Oxford Knee Score

To demonstrate, through calculation of Oxford Knee Score (OKS) post operatively, that total knee replacement (TKR) performed using the ShapeMatch® Cutting Guide provides improvement from preoperative levels of patient pain and function comparable to the improvement obtained with TKR performed using computer-assisted Navigation. Oxford Knee Scores will be calculated pre-operatively and at 6 weeks, 6 months, 12 months, 2 years and 5 years. The OKS is a participant completed 12 question form on activities of daily living that assess function and pain. Scores can range from 0 to 48 with lower scores indicating a poor outcome and higher scores indicating a more satisfactory joint outcome.

Time frame: Preoperatively, 6-week, 6-months, 12 months, 2 years and 5 years postoperatively

Secondary Outcomes

Cost Effectiveness: Total Duration of Operating Procedure (Anaesthetic Time and Skin-to-skin Incision Time)

Skin to skin time is the time in minutes from initial skin incision to skin closure. Anaesthesia time is the time in minutes that anaesthesia administration is started to the time it is stopped. Data for anaesthesia time is not available due to an error on the original case report form that did not correctly capture anaesthesia time.

Time frame: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.

Cost Effectiveness: Wound Length

To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group the surgical incision length is reported in mm.

Time frame: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.

Cost Effectiveness: Cost of Consumable Items Used During Operating Procedure

To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group. The data for the cost of consumable items used during the operating procedure is not available. Due to limited site resources, a decision was made not to collect this secondary outcome measure data.

Data from ClinicalTrials.gov

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