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Completed

NCT Number: NCT02524730

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

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

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Key information

Conditions

Arthroplasty, Replacement, Knee

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Hospital Innsbruck, Innsbruck, Tyrol, Austria

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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°

Treatment and study plan

Primary total knee replacement (Scorpio NRG CR Total Knee System)

Device

Scorpio NRG CR Total Knee System

Primary outcomes

  1. Survival Rate

    Time frame: 7 year follow-up

    Assess survival (absence of revision) at 7 year follow-up

Secondary outcomes

  1. Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)

    Time frame: Pre-operative, 3 months, 1, 3, 5 and optional 7 years

    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.

  2. Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire

    Time frame: Pre-operative, 3 months,1, 3, 5 and optional 7 years

    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.

  3. Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)

    Time frame: Pre-operative, 3 months,1, 3, 5 and optional 7 years

    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.

  4. Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.

    Time frame: Pre-operative,1, 5 and optional 7 years

    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).

  5. Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).

    Time frame: Pre-operative, 3 months,1, 3, 5 and optional 7 years

    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).

Sponsors and collaborators

Lead sponsor

Stryker Orthopaedics

Industry

Registry information

Official study title

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

Acronym: Scorpio NRG

Important dates

Study start
2009
Primary completion
2020
Study completion
2020
First posted
Aug 17, 2015
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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