Clinical trial NCT02520531: Scorpio Posterior Stabilised (PS) vs Scorpio NRG ("Energize") PS - Total Knee Arthroplasty
Official title: Scorpio PS vs Scorpio NRG PS - Total Knee Arthroplasty Comparative Investigation of Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2015-08-13
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of Maximum Passive and Active Flexion.
timeFrame: 5 years follow-up
Secondary outcomes:
measure: Knee Society Score (KSS)
timeFrame: pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up
measure: Chair Raise Test
timeFrame: pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up
measure: WOMAC Patient Questionnaire
timeFrame: pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up
measure: EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire
timeFrame: pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Central Trial Center Maastricht BV
state: Limburg
Study officials:
affiliation: Clinical Trial Center Maastricht BV
name: Peter Feczko, MD
role: PRINCIPAL_INVESTIGATOR
References: