Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using ShapeMatch® Cutting Guides: Sub-Study B

NCT ID: NCT02527161

Last Updated: 2020-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2018-04-30

Brief Summary

This is a prospective, non-randomized, longitudinal study of the clinical outcomes of participants that receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using ShapeMatch® Cutting Guides.

Health status and functional outcome measures will be recorded to quantify functional status of subjects before surgery and at each follow-up interval. This sub-study involved the assessment of the placement of the ShapeMatch® Cutting Guides intraoperatively and post-operatively. An assessment of post-operative patient outcomes compared to pre-operative status was also analysed.

Detailed Description

Protocol Attached in documentation.

Conditions

Arthroplasties, Replacement, Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ShapeMatch Cutting Guides with Triathlon

The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.

They are intended for single use only.

Group Type: OTHER

ShapeMatch Cutting Guides with Triathlon

Intervention Type: DEVICE

All participants will undergo medical imaging assessment using Magnetic Resonance Imaging (MRI) of the affected lower limb.These images will be used to manufacture the patient-specific cutting guides for preparation of the bones prior to implantation of the total knee replacement (Pre-operatively). Patients will undergo primary total knee arthroplasty with the Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, NJ USA) using the Shapematch cutting guides to guide the bone resection. Patients will follow the standard postoperative rehabilitation program established by the investigator at each site.

Interventions

ShapeMatch Cutting Guides with Triathlon

All participants will undergo medical imaging assessment using Magnetic Resonance Imaging (MRI) of the affected lower limb.These images will be used to manufacture the patient-specific cutting guides for preparation of the bones prior to implantation of the total knee replacement (Pre-operatively). Patients will undergo primary total knee arthroplasty with the Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, NJ USA) using the Shapematch cutting guides to guide the bone resection. Patients will follow the standard postoperative rehabilitation program established by the investigator at each site.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The patient is a male or non-pregnant female between the ages of 50-90.
• The patient requires a primary total knee replacement and is indicated for computer-assisted surgery.
• 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, HREC-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.
• The patient has had a high tibial osteotomy or femoral osteotomy.
• 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.
• The 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).

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker South Pacific

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

TriShapeMatch-10_SubStudyB

Identifier Type: -

Identifier Source: org_study_id