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

NCT02520531 | Completed Results

• 1 other identifier: 20100506 /K-S-006
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Comparison of Maximum Passive and Active Flexion.

  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.

  5 years follow-up

Secondary Outcomes (4)

• Knee Society Score (KSS)

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

• Chair Raise Test

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

• WOMAC Patient Questionnaire

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

• EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire

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

Study Arms (2)

Scorpio PS

ACTIVE COMPARATOR

Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio PS Total Knee Replacement.

Device: Scorpio PS (posterior stable)

Scorpio NRG PS

ACTIVE COMPARATOR

Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio NRG PS Total Knee Replacement.

Device: Scorpio NRG PS

Interventions

Scorpio PS (posterior stable) DEVICE

Implantation of total knee prosthesis

Scorpio PS

Scorpio NRG PS DEVICE

Implantation of total knee prosthesis

Scorpio NRG PS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (1)

Central Trial Center Maastricht BV

Maastricht, Limburg, 6229 HX, Netherlands

Location

Results Point of Contact

• Title: Britta von den Brincken, Clinical Study Manager
• Organization: Stryker

britta.vondenbrincken@stryker.com

+491638999202

Study Officials

• Peter Feczko, MD

  Clinical Trial Center Maastricht BV

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: August 13, 2015
• Study Start: September 1, 2010
• Primary Completion: June 28, 2018
• Study Completion: June 28, 2018
• Last Updated: February 22, 2024
• Results First Posted: September 20, 2019

Record last verified: 2024-02

Locations

NL (1)