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Should my New Knee Rotate?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02892838
Recruitment Status : Completed
First Posted : September 8, 2016
Last Update Posted : April 26, 2018
Sponsor:
Collaborator:
Stryker Nordic
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Arthritis of the Knee Joint Device: mobile bearing knee system for total knee arthroplasty Device: fixed bearing total knee prosthesis Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2003
Actual Primary Completion Date : November 2008
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

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



Primary Outcome Measures :
  1. Anterior knee pain during stair rise [ Time Frame: 5 years ]
    Anterior knee pain using VAS during stair rise at different follow up moments until 5 years after surgery

  2. Anterior knee pain during stair climb [ Time Frame: 5 years ]
    Anterior knee pain using VAS during stair climb at different FU moments


Secondary Outcome Measures :
  1. passive and active Range of motion [ Time Frame: 5 years ]
    measuring passive and active range of motion (flexion / extension) using a goniometer at different FU moments

  2. patella compression pain [ Time Frame: 5 years ]
    patella compression pain at physical examination at different FU moments defined as yes of no when putting mild pressure on the patella

  3. patient satisfaction [ Time Frame: 5 years ]
    measuring patient satisfaction using the RAND-36 questionnaire at different FU moments



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892838


Sponsors and Collaborators
Maastricht University Medical Center
Stryker Nordic
Investigators
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Principal Investigator: Peter Feczko, MD orthopedic surgeon MUMC Maastricht
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02892838    
Other Study ID Numbers: METC02-055
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Maastricht University Medical Center:
mobile bearing knee prosthesis
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases