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

Not Applicable

Completed

Conditions: Arthroplasties, Replacement, Knee

Interventions: Device: ShapeMatch Cutting Guides with Triathlon

Registration Number: NCT02527161

Lead Sponsor: Stryker South Pacific

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 205

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ShapeMatch Cutting Guides with Triathlon	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.

Primary Outcome Measures

Name	Time	Method
Implant Location/Assessment of Alignment	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 Outcome Measures

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