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: Sub-Study B

Stryker South Pacific0 sites205 target enrollmentJune 2011

ConditionsArthroplasties, Replacement, Knee

Overview

Phase: N/A
Intervention: Not specified
Conditions: Arthroplasties, Replacement, Knee
Sponsor: Stryker South Pacific
Enrollment: 205
Primary Endpoint: Implant Location/Assessment of Alignment
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

April 2018

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Stryker South Pacific

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The patient is a male or non-pregnant female between the ages of 50-
•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.

Outcomes

Primary Outcomes

Implant Location/Assessment of Alignment

Time Frame: 3 months Post-Operatively

Implant location and limb alignment is assessed using CT scan 3 months after surgery. The mean deviation of the postoperative femoral and tibial alignment from the preoperative plan is measured in degrees.

Secondary Outcomes

Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL(Pre-operative to 5 years post-operative)
Knee Society Clinical Rating System (KSS) Range of Motion Scores(Pre-operative to 5 years Post-Operative)
Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain(Pre-operative to 5 years post-operative)
Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms(Pre-operative to 5 years post-operative)
Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R(Pre-operative to 5 years Post-Operative)
Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL(Pre-operative to 5 years post-operative)
Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS)(Pre-operative to 5 years Post-Operative)
VAS Pain at Rest(Pre-Operative to 5 years Post-Operative)
Knee Society Clinical Rating System (KSS) Pain Scores(Pre-operative to 5 years Post-Operative)
Forgotten Joint Score (FJS)(1 to 5 years Post-Operative)
VAS Pain Mobilised(Pre-Operative to 5 years post-operative)
Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS)(Pre-operative to 5 years Post-Operative)
Knee Society Clinical Rating System (KSS) Functional Scores(Pre-operative to 5 years Post-Operative)