Scorpio Posterior Stabilised (PS) vs Scorpio NRG ("Energize") PS

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2018-06-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Arthroplasty, Replacement, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Scorpio PS

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.

Group Type ACTIVE_COMPARATOR

Scorpio PS (posterior stable)

Intervention Type DEVICE

Implantation of total knee prosthesis

Scorpio NRG PS

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.

Group Type ACTIVE_COMPARATOR

Scorpio NRG PS

Intervention Type DEVICE

Implantation of total knee prosthesis

Interventions

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Scorpio PS (posterior stable)

Implantation of total knee prosthesis

Intervention Type DEVICE

Scorpio NRG PS

Implantation of total knee prosthesis

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No