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

Stryker

Status: Completed

Conditions: Arthroplasty, Replacement, Knee

Treatments: Device: Scorpio NRG PS; Device: Scorpio PS (posterior stable)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02520531

20100506 /K-S-006

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

Scorpio PS

Active Comparator group

Description:

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.

Treatment:

Device: Scorpio PS (posterior stable)

Scorpio NRG PS

Active Comparator group

Description:

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.

Treatment:

Device: Scorpio NRG PS