出境医 / 临床实验 / RSA Study of Persona TKA With CR vs MC Polyethylene

RSA Study of Persona TKA With CR vs MC Polyethylene

Study Description
Brief Summary:
The aim of this study is to evaluate, over a 2 year period, the migration pattern, function and the possibility of anatomical reconstruction of a relatively new total knee arthroplasty (TKA) concept, the Persona. Sixty patients will be randomized into 2 groups of 30 patients each, with one group receiving the Persona TKA with a conventional Cruciate Retaining (CR) polyethylene articular surface and the other group with a newly developed Medial Congruent (MC) articular surface. Patients will be followed up with Radiostereometry (RSA), conventional radiography, outcome questionnaires, clinical evaluation and Computer Tomography (CT). The migration pattern of the components will be evaluated as well as the degree of anatomical reconstruction and clinical result.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: Medial Congruent Polyethylene (MC) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Aspects of Alignment, Function, and Migration Behaviour in Two Conceptually Different Articular Surface Designs in the Cruciate Retaining Version of the Cemented Persona Knee System - A Randomized Study Evaluated by RSA and CT Analysis
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : October 30, 2020
Estimated Study Completion Date : December 2023
Arms and Interventions
Arm Intervention/treatment
No Intervention: Cruciate Retaining Polyethylene (CR)
This is the standard Polyethylene articular surface
Active Comparator: Medial Congruent Polyethylene (MC)
The intervention here will be the MC articular surface. This is the new Polyethylene articular surface with a more congruent medial side and a more flat lateral side which should better resemble natural anatomy.
 Device: Medial Congruent Polyethylene (MC)
One group receives the conventional CR surface and the other the new MC articular surface
Other Name: MC
Outcome Measures
Primary Outcome Measures :
  1. Radiostereometry (RSA) [ Time Frame: First postoperative day, 3 months, 1 year and 2 years ]
    Measure the change in component migration over time (translation and rotation around the x-, y- and z-axis)


Secondary Outcome Measures :
  1. Computer Tomography (CT) [ Time Frame: Preoperatively and 3 months postoperatively ]
    Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position

  2. Conventional radiography [ Time Frame: Preoperatively and 3 months postoperatively ]
    Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position

  3. General health questionnaire [ Time Frame: Preoperatively, 1 and 2 years postoperatively ]
    EuroQol (EQ-5D) -standardized instrument for use of general health outcome

  4. Knee specific health questionnaire [ Time Frame: Preoperatively, 1 and 2 years postoperatively ]
    Knee disability and Osteoarthritis Outcome Score (KOOS) - this is a knee specific questionnaire measuring patients knee function and pain situation


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Osteoarthritis of the knee necessitating knee replacement
  • ASA I-III
  • BMI 18 - 35

Exclusion Criteria:

  • Joint sepsis in history
  • immunosuppresive drugs last 5 years
  • Rheumatoid arthritis
  • Severe osteoporosis or other metabolic bone diseases
  • Neuromuscular diseases
  • Personal disorders suspected of limiting rehab and completion of the trial period
  • Previous osteotomy of affected limb
  • Intra-articular knee fracture of affected limb
  • Peroperative fracture
  • Severe deformity of affected joint in need of augmentation or excessive release
  • Obvious need for more constrained knee than CR
Contacts and Locations

Locations
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Sweden
Department of Orthopedics, Skane University Hospital, Lund University
Lund, Sweden, 22185
Sponsors and Collaborators
Region Skane
Zimmer Biomet
Investigators
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Principal Investigator: Gunnar Flivik, MD PhD Dept of Orthopedics, Skåne University Hospital

Tracking Information
First Submitted Date  ICMJE April 3, 2018
First Posted Date  ICMJE April 11, 2018
Last Update Posted Date December 22, 2020
Actual Study Start Date  ICMJE October 1, 2017
Actual Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2018) 		Radiostereometry (RSA) [ Time Frame: First postoperative day, 3 months, 1 year and 2 years ]
Measure the change in component migration over time (translation and rotation around the x-, y- and z-axis)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2018)
  • Computer Tomography (CT) [ Time Frame: Preoperatively and 3 months postoperatively ]
    Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position
  • Conventional radiography [ Time Frame: Preoperatively and 3 months postoperatively ]
    Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position
  • General health questionnaire [ Time Frame: Preoperatively, 1 and 2 years postoperatively ]
    EuroQol (EQ-5D) -standardized instrument for use of general health outcome
  • Knee specific health questionnaire [ Time Frame: Preoperatively, 1 and 2 years postoperatively ]
    Knee disability and Osteoarthritis Outcome Score (KOOS) - this is a knee specific questionnaire measuring patients knee function and pain situation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RSA Study of Persona TKA With CR vs MC Polyethylene
Official Title  ICMJE Aspects of Alignment, Function, and Migration Behaviour in Two Conceptually Different Articular Surface Designs in the Cruciate Retaining Version of the Cemented Persona Knee System - A Randomized Study Evaluated by RSA and CT Analysis
Brief Summary The aim of this study is to evaluate, over a 2 year period, the migration pattern, function and the possibility of anatomical reconstruction of a relatively new total knee arthroplasty (TKA) concept, the Persona. Sixty patients will be randomized into 2 groups of 30 patients each, with one group receiving the Persona TKA with a conventional Cruciate Retaining (CR) polyethylene articular surface and the other group with a newly developed Medial Congruent (MC) articular surface. Patients will be followed up with Radiostereometry (RSA), conventional radiography, outcome questionnaires, clinical evaluation and Computer Tomography (CT). The migration pattern of the components will be evaluated as well as the degree of anatomical reconstruction and clinical result.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE Device: Medial Congruent Polyethylene (MC)
One group receives the conventional CR surface and the other the new MC articular surface
Other Name: MC
Study Arms  ICMJE
  • No Intervention: Cruciate Retaining Polyethylene (CR)
    This is the standard Polyethylene articular surface
  • Active Comparator: Medial Congruent Polyethylene (MC)
    The intervention here will be the MC articular surface. This is the new Polyethylene articular surface with a more congruent medial side and a more flat lateral side which should better resemble natural anatomy.
    Intervention: Device: Medial Congruent Polyethylene (MC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 10, 2018) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Actual Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Osteoarthritis of the knee necessitating knee replacement
  • ASA I-III
  • BMI 18 - 35

Exclusion Criteria:

  • Joint sepsis in history
  • immunosuppresive drugs last 5 years
  • Rheumatoid arthritis
  • Severe osteoporosis or other metabolic bone diseases
  • Neuromuscular diseases
  • Personal disorders suspected of limiting rehab and completion of the trial period
  • Previous osteotomy of affected limb
  • Intra-articular knee fracture of affected limb
  • Peroperative fracture
  • Severe deformity of affected joint in need of augmentation or excessive release
  • Obvious need for more constrained knee than CR
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03494348
Other Study ID Numbers  ICMJE Persona RSA study_MT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Region Skane
Study Sponsor  ICMJE Region Skane
Collaborators  ICMJE Zimmer Biomet
Investigators  ICMJE
Principal Investigator: Gunnar Flivik, MD PhD Dept of Orthopedics, Skåne University Hospital
PRS Account Region Skane
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP