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Clinical Outcome After Total Knee Arthroplasty Using CR or PS Inlay

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ClinicalTrials.gov Identifier: NCT03873363
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden

Brief Summary:
Compare knee flexion after cruciate-retaining and cruciate substituting Total Knee Arthroplasty.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: PS TKA Device: CR TKA Not Applicable

Detailed Description:

The aim of this study is to compare knee Flexion after cruciate-retaining (CR) and cruciate-substituting (posterior stabilized - PS) Total Knee Arthroplasty (TKA).

For this purpose, flexion and extension of the knee joint are measured using a goniometer preoperatively and up to ten years after surgery In addition, the clinical outcome will be assessed and evaluated using internationally recognised and evaluated scores (Knee Society Score, Oxford Knee Score, EQ5D, UCLA Activity Score).

Patients are randomized to receive a PS or CR TKA. Patients are assessed before surgery, after 3 months, 1 year, 2 years, 5 years, 7 years and 10 years postoperatively.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization to one of two surgical techniques.
Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Treatment
Official Title: Prospective Randomized Comparison of Cruciate-retaining and Cruciate Substituting Surgical Technique for Total Knee Arthroplasty
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : September 1, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: PS
Implantation of a posterior stabilized (cruciate substituting) Total Knee Arthroplasty.
Device: PS TKA
Implantation of a posterior stabilized (cruciate substituting) Total Knee Arthroplasty.

Active Comparator: CR
Implantation of a cruciate retaining Total Knee Arthroplasty.
Device: CR TKA
Implantation of a cruciate retaining Total Knee Arthroplasty.




Primary Outcome Measures :
  1. Knee Flexion [ Time Frame: 1 year after surgery ]
    Knee flexion measured using a goniometer


Secondary Outcome Measures :
  1. Function assessed by the Knee Society Score [ Time Frame: 10 years after surgery ]
    Knee Society Score

  2. Patient Reported Outcome [ Time Frame: 10 years after surgery ]
    Oxford Knee Score

  3. Health-related Quality of Life [ Time Frame: 10 years after surgery ]
    EQ-5D-3L

  4. Activity assessed by UCLA activity score [ Time Frame: 10 years after surgery ]
    UCLA activity score


Other Outcome Measures:
  1. Adverse Events [ Time Frame: 1 year after surgery ]
    Adverse Events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Indication for TKA with a non-linked, bicondylar total knee replacement
  • written informed consent

Exclusion Criteria:

  • Chronic pain patients
  • Neuromuscular Diseases
  • general illnesses that make mobilisation more difficult and/or prevent follow-up
  • Known posterior cruciate ligament insufficiency
  • Need for a higher degree of linkage
  • BMI over 40 kg/m²
  • Study doctor, his family, employees or other dependent persons

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): NCT03873363


Contacts
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Contact: Jörg Lützner, MD +49(0)351 458 2613 Joerg.Luetzner@uniklinikum-dresden.de

Locations
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Germany
University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden Recruiting
Dresden, Saxonia, Germany, 01307
Contact: Jörg Lützner, MD       Joerg.Luetzner@uniklinikum-dresden.de   
Sponsors and Collaborators
Technische Universität Dresden

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Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT03873363     History of Changes
Other Study ID Numbers: TKA CR vs PS
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Technische Universität Dresden:
Total Knee Arthroplasty
Total Knee Replacement
Outcome
Implant Design
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases