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

NCT02527148 | Completed Results

• 1 other identifier: ShapeNZRCT-10
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Arthroplasties; Knee Replacement

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (11)

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

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

• Cost Effectiveness: Wound Length

  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

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

• Cost Effectiveness: Length of Stay in Hospital

  14 days

• Cost Effectiveness: Quality-adjusted Life-years (QALYs) From EQ-5D-3L

  12 months

Study Arms (2)

OtisMed® ShapeMatch® with Triathlon

ACTIVE COMPARATOR

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).

Device: OtisMed® ShapeMatch® Technology; Procedure: Total Knee Replacement; Device: Stryker Triathlon® Total Knee System

Stryker Precision Knee Navigation

ACTIVE COMPARATOR

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.

Device: Stryker Precision Knee Navigation; Procedure: Total Knee Replacement; Device: Stryker Triathlon® Total Knee System

Interventions

OtisMed® ShapeMatch® Technology DEVICE

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

OtisMed® ShapeMatch® with Triathlon

Stryker Precision Knee Navigation DEVICE

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.

Stryker Precision Knee Navigation

Total Knee Replacement PROCEDURE

OtisMed® ShapeMatch® with Triathlon; Stryker Precision Knee Navigation

Stryker Triathlon® Total Knee System DEVICE

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® with Triathlon; Stryker Precision Knee Navigation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stryker South Pacific: lead

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Results Point of Contact

• Title: David Fulker
• Organization: Stryker South Pacific

david.fulker@stryker.com

+61 2 9467 1072

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: August 18, 2015
• Study Start: August 4, 2011
• Primary Completion: April 9, 2018
• Study Completion: December 19, 2018
• Last Updated: May 15, 2025
• Results First Posted: January 12, 2016

Record last verified: 2025-05