Scorpio NRG (eNeRGize) Cruciate Retaining (CR) Post-market International Outcome Study

Study Overview
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Brief Summary
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The purpose of this study is to collect basic function, radiographic and patient satisfaction data for observation and analysis.

Detailed Description
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Evaluation of the effect of the component design on functional performance by comparing postoperative Knee Society Scores (KSS) with preoperative. Evaluate post-operative radiographic findings. Evaluate the effect of component design on patient activity by comparing postoperative Lower Extremity Activity Scale (LEAS) with preoperative. Evaluate patient satisfaction using Short-Form-36 Health Survey (SF-36). Evaluate quality of life using Knee Injury and Osteoarthritis Outcome Score (KOOS) and EuroQuol-5 dimension patient questionaire (EQ-5D).

Official Title
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Scorpio NRG Prospective, Open-label, Post-market International Multicentre Outcome Study

Conditions
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Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Device: Primary total knee replacement (Scorpio NRG CR Total Knee System)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is able to understand the meaning of the study and is willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form. The subject is a male or non-pregnant female between 40 and 75 years of age. The subject requires a primary total knee replacement. Patients with osteoarthritis or posttraumatic arthritis (no rheumatoid arthritis) The subject has intact collateral ligaments. The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation. The subject is capable of understanding the patient scores in the national language. Exclusion Criteria: The subject is morbidly obese, defined as Body Mass Index (BMI) of > 40. The subject has a history of total or unicompartmental reconstruction of the affected joint. The subject will be operated bilaterally. Patients who had a Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (Patients with contralateral and/or ipsilateral THA > 1 year ago with good outcome can be included in the study). Patients who had a Total Knee Arthroplasty (TKA) on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA > 6 months ago with good outcome can be included in the study). Patients who will need lower limb joint replacement for another joint within one year. The subject has had a high tibial osteotomy or femoral osteotomy. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. The subject has a systemic or metabolic disorder leading to progressive bone deterioration. The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements. The subject's bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis. The subject has had a knee fusion to the affected joint. The subject has an active or suspected latent infection in or about the knee joint. Proven or suspected hypersensitivity to one or more than one of the device materials (see Appendix 10 table of chemical composition). Female patients planning a pregnancy during the course of the study. The subject is a prisoner. severe deformities: varus/valgus deformity >10° (mech. axis), bowed femur > 20 degree, flexion contracture >10°

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 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: Scorpio NRG CR Total Knee System<br>Primary total knee replacement | Device: Primary total knee replacement (Scorpio NRG CR Total Knee System)<br>* Scorpio NRG CR Total Knee System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Rate | Assess survival (absence of revision) at 7 year follow-up | 7 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 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 potential minimum score of 0 to a maximum score 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, 3 months, 1, 3, 5 and optional 7 years | 
| Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. | Pre-operative, 3 months,1, 3, 5 and optional 7 years | 
| Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36) | The SF-36 is a 36-item patient completed questionnaire to measure general health and well-being. It includes physical and mental status component sub scores (physical function, physical role functioning, body pain, general health, vitality, social functioning, emotional role, mental health); each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. | Pre-operative, 3 months,1, 3, 5 and optional 7 years | 
| Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire. | KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms). | Pre-operative,1, 5 and optional 7 years | 
| Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; EQ-5D descriptive system and the visual analogue scale (VAS). The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health. With the EQ VAS the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status). | Pre-operative, 3 months,1, 3, 5 and optional 7 years |