Should my New Knee Rotate?

Should my New Knee Rotate? A Randomised, Controlled Clinical Trial to Compare Fixed and Mobile Bearing Total Knee Arthroplasties Using the SCORPIO PS and SCORPIO+ PS Knee Systems

Total Knee Arthroplasty (TKA) is the surgical reconstruction of the knee joint in order to relieve pain, restore function and correct deformity. It is a very common surgical procedure with figures showing more than 500'000 arthroplasties performed annually worldwide. Total knee arthroplasty is considered one of the most successful types of joint reconstruction in that surgical results usually meet and even exceed expectations. Much of the current literature focuses on the issues relating to implant wear as a potential failure mode for artificial knee implants. It has been suggested that knee with mobile or rotating bearing options, such as the comparative device proposed for this clinical investigation, may survive longer than fixed bearing knee designs because of the greater contact surface area possible with more congruent components with unconstrained, mobile component design.

Study Overview

• Status: Completed
• Conditions: Arthritis of the Knee Joint
• Intervention / Treatment: Device: mobile bearing knee system for total knee arthroplasty; Device: fixed bearing total knee prosthesis

Detailed Description

This is a prospective, comparative, randomised, open-label, single center, multiple surgeons clinical study. The Scorpio PS Superflex and the Scorpio PS mobile bearing are to be implanted for evaluation in this study. Patients will be randomised to one of two equal sized groups. In the first group patients will be treated with the Scorpio PS Superflex, whilst in the second group patients will be treated with the Scorpio PS mobile bearing implant.

Evaluations consist of the KSS score, Chair rise and stair climb tests, radiology assessments, patient questionnaires, at multiple timepoints: pre-operative, 6 weeks, 3 months, 6 months 1 year, 2 years and 5 years post-operatively.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients requiring cemented primary total knee replacement.
• Patients with a diagnosis of osteoarthritis (OA), avascular necrosis (AVN) or post-traumatic arthritis (TA)
• Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation.
• Patient who have intact collateral ligaments.
• Patient who signed the Ethics Committee approved specific Informed Consent Form prior to surgery.

Exclusion Criteria:

• Patient where patella will not be resurfaced.
• Patients with active or suspected infection.
• Patients with a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (i.e. severe osteoporosis, Paget's disease, renal osteodystrophy) or is immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
• The patient has a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weightbearing or places an extreme load on the implant during the healing period.
• Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: mobile bearing knee prosthesis; use of the Scorpio mobile bearing knee system for total knee arthroplasty	Device: mobile bearing knee system for total knee arthroplasty
ACTIVE_COMPARATOR: fixed bearing; use of the Scorpio fixed bearing knee system for total knee arthoplasty	Device: fixed bearing total knee prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anterior knee pain during stair rise	Anterior knee pain using VAS during stair rise at different follow up moments until 5 years after surgery	5 years
Anterior knee pain during stair climb	Anterior knee pain using VAS during stair climb at different FU moments	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
passive and active Range of motion	measuring passive and active range of motion (flexion / extension) using a goniometer at different FU moments	5 years
patella compression pain	patella compression pain at physical examination at different FU moments defined as yes of no when putting mild pressure on the patella	5 years
patient satisfaction	measuring patient satisfaction using the RAND-36 questionnaire at different FU moments	5 years

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Stryker Nordic
• Investigators: Principal Investigator: Peter Feczko, MD, orthopedic surgeon MUMC Maastricht

Publications and helpful links

General Publications

• Feczko PZ, Jutten LM, van Steyn MJ, Deckers P, Emans PJ, Arts JJ. Comparison of fixed and mobile-bearing total knee arthroplasty in terms of patellofemoral pain and function: a prospective, randomised, controlled trial. BMC Musculoskelet Disord. 2017 Jun 29;18(1):279. doi: 10.1186/s12891-017-1635-9.

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (ACTUAL): November 1, 2008
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: September 2, 2016
• First Submitted That Met QC Criteria: September 2, 2016
• First Posted (ESTIMATE): September 8, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2018
• Last Update Submitted That Met QC Criteria: April 25, 2018
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: mobile bearing knee prosthesis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: METC02-055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO