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

Study Overview
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Brief Summary
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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
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Protocol Attached in documentation.

Official Title
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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

Conditions
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Arthroplasties, Replacement, Knee

Intervention / Treatment
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* Device: ShapeMatch Cutting Guides with Triathlon


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ShapeMatch Cutting Guides with Triathlon<br>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. | Device: ShapeMatch Cutting Guides with Triathlon<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Location/Assessment of Alignment | 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. | 3 months Post-Operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score (KOOS)_Pain | KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.) | Pre-operative to 5 years post-operative | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS)_Symptoms | KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.) | Pre-operative to 5 years post-operative | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS)_ADL | KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.) | Pre-operative to 5 years post-operative | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS)_S&R | KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.) | Pre-operative to 5 years Post-Operative | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS)_QOL | KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.) | Pre-operative to 5 years post-operative | 
| Short Form Health Survey 12 v2 (SF-12)_Physical Component Summary (PCS) | SF-12 provides a summary measure of health status after combining the physical health score (PCS) and mental health score (MCS). The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state. | Pre-operative to 5 years Post-Operative | 
| VAS Pain at Rest | Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain. | Pre-Operative to 5 years Post-Operative | 
| VAS Pain Mobilised | Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain. | Pre-Operative to 5 years post-operative | 
| Short Form Health Survey 12 (SF-12)_Mental Component Summary (MCS) | SF-12 provides a summary measure of health status after combining the physical health score (PCS) and mental health score (MCS). The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state. | Pre-operative to 5 years Post-Operative | 
| Knee Society Clinical Rating System (KSS) Pain Scores | The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome. | Pre-operative to 5 years Post-Operative | 
| Knee Society Clinical Rating System (KSS) Functional Scores | The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome. | Pre-operative to 5 years Post-Operative | 
| Knee Society Clinical Rating System (KSS) Range of Motion Scores | The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome. | Pre-operative to 5 years Post-Operative | 
| Forgotten Joint Score (FJS) | The Forgotten Joint Score is a newly-developed twelve-item, self-reported assessment of how aware recipients of hip and knee joint replacement are of their joint in everyday life. The total score for the FJS is summed, averaged then multiplied by 25 (never = 0 points; almost never = 1 point; seldom = 2 points; sometimes = 3 points; mostly = 4 points). Total score range of 0 to 100. | 1 to 5 years Post-Operative |