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Completed

NCT Number: NCT02520531

Scorpio Posterior Stabilised (PS) vs Scorpio NRG ("Energize") PS - Total Knee Arthroplasty

Single-centre, prospective, randomized comparative study to compare the maximum flexion and Chair Raise achievement ratios of the Scorpio PS and and the Scorpio NRG PS. Documentation of all complications.

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Key information

Conditions

Arthroplasty, Replacement, Knee

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Trial Center Maastricht BV

Maastricht, Limburg, 6229 HX, Netherlands

About this study

Surveillance design: Single-centre, prospective, randomized comparative study. Objectives: To compare the maximum flexion (active and passive) and Chair Raise achievement ratios. All complications will be documented.

Number of subjects to be enrolled: All consecutive Scorpio patients are included until a group size of 88 is reached.

Clinical evaluations: Chair raise test, Stair climb test, Western Ontario McMaster Osteoarthritis Index (WOMAC) patient self evaluation, EuroQuol - 5 dimension (EQ-5D) patient questionnaire. Standard clinical, functional and pain parameters (Knee Society Score), pre-operatively and post-operatively. All per- and post-op complications.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients requiring a primary total knee arthroplasty (TKA)
  • Male and nonpregnant female patients
  • Between 18 and 80 years of age at time of surgery
  • Patients with a diagnosis of osteoarthritis (OA), avascular necrosis (AVN), and not severe posttraumatic arthritis
  • No previous osteosynthesis of the involved knee during the last 12 months
  • Patients who understand the conditions of the study and are wiling to participate for the length of the described follow up
  • Patients who are capable of, and have given, informed consent for participation in the study

Exclusion criteria

  • Patients requiring revision surgery of a previous implanted total knee system
  • Patients with a diagnosis of severe posttraumatic arthritis (TA) and rheumatoid arthritis (RA)
  • Patients with active infection
  • Patients with malignancy
  • Patients with an immobile hip or ankle arthrodesis
  • Severe obese patients (BMI > 35)
  • Patients with a neurological deficit
  • Previous history of unicompartmental knee arthroplasty or patellar prosthesis
  • Patients with concurrent illnesses which are likely to affect their outcome

Treatment and study plan

Scorpio PS (posterior stable)

Device

Implantation of total knee prosthesis

Scorpio NRG PS

Device

Implantation of total knee prosthesis

Primary outcomes

  1. Comparison of Maximum Passive and Active Flexion.

    Time frame: 5 years follow-up

    Comparison of maximum flexion, both passive and active between Scorpio NRG PS knee prosthesis and the Scorpio PS knee prosthesis.

    The active flexion-tolerated range is greater/equal 70 degree. The passive flexion-tolerated range is greater/equal 80 degree. The Hyperextension tolerated range is 0 to 10 degree. Higher scores mean a better outcome.

Secondary outcomes

  1. Knee Society Score (KSS)

    Time frame: pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up

    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. Chair Raise Test

    Time frame: pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up

    A measurement to assess functional lower extremity strength. The participant is seated on a chair. Arms are crossed at the wrists and held against the chest. The participant is instructed to arise from an adjustable chair with the knees in a 90 degree angle (measurement with Goniometer) without using arms.

  3. WOMAC Patient Questionnaire

    Time frame: pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up

    The WOMAC collects information specific to osteoarthritis outcomes. The patient response questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and function. Each question is scored from 0 to 4 for each set of factors, with 0 indicating no pain, stiffness, or limited in function, and 4 indicating extreme pain stiffness, or limited in function. Total WOMAC scores range from 0 to 96 wit lower values representing better outcomes.

  4. EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire

    Time frame: pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up

    The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. 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.

Sponsors and collaborators

Lead sponsor

Stryker Orthopaedics

Industry

Registry information

Official study title

Scorpio PS vs Scorpio NRG PS - Total Knee Arthroplasty Comparative Investigation of Function

Acronym: ScorpioNRGPS

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Aug 13, 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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