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Comparison of an Old Versus a New Total Knee Replacement

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. Identifier: NCT03548792
Recruitment Status : Active, not recruiting
First Posted : June 7, 2018
Last Update Posted : August 12, 2019
Information provided by (Responsible Party):
Mona Badawy, Haukeland University Hospital

Brief Summary:

A randomized controlled clinical and RSA study, comparing 2 knee implants:

  1. NexGen CR cemented total knee arthroplasty
  2. Persona CR cemented total knee arthroplasty

3 hospitals will participate in the study:

  • Helse Bergen HF, Kysthospitalet i Hagavik (KIH)
  • Helse Førde HF, Lærdal sykehus
  • Helse Bergen HF, Haukeland universitetssykehus (HUS) 1-3 surgeons in each hospital will perform the operations. There will be 80 patients in the 2 groups; a total of 160 study patients will be included. 30 in each group will be included for RSA. Radiostereometric analysis (RSA) will be used to measure migration and subsidence of components in addition to regular radiographs.

    3 different knee scoring systems will be used to evaluate satisfaction and function. An activity monitor will be used to assess real-life physical behavior and walking speed to assess objectively measured mobility.

Data from the Norwegian Arthroplasty Register will be used to investigate the risk of revision.

Condition or disease Intervention/treatment Phase
Osteoarthritis Knee Radiation: RSA radiostereometric analysis Behavioral: Clinical comparison Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Clinical and RSA Study of 2 Total Knee Replacement Designs: A Comparison of Nexgen CR and Persona CR
Actual Study Start Date : May 18, 2017
Estimated Primary Completion Date : July 5, 2029
Estimated Study Completion Date : July 5, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
RSA radiostereometric analysis
30 patients in each Group Persona or Nexgen will receive tantalus beads to achieve RSA analysis comparing micromevements in radiographs.
Radiation: RSA radiostereometric analysis
Tantalum beads will be inserted in polyethylene Component and in bone to assess micromotion of Components in radiographs

Clinical comparison
Clinical comarison using different patient reported outcome measures and objective measures (ActivePAL, walking speed)
Behavioral: Clinical comparison
ActivePAL, walking speed

Primary Outcome Measures :
  1. FJS12 [ Time Frame: 10 year follow up ]
    Forgotten joint score 12

Secondary Outcome Measures :
  1. KSS [ Time Frame: 10 years ]
    Knee society score

  2. KOOS [ Time Frame: 10 years ]
    Knee injury and osteoarthritis score

  3. EQ5D [ Time Frame: 10 years ]
    Euroqol 5 dimention questionnaire

  4. Revision risk [ Time Frame: 10 years ]
    Data Collection from Norwegian arthroplasty register

  5. Walking speed [ Time Frame: 10 years ]
    4 meter walking speed

  6. ActivePAL3TM [ Time Frame: 10 years ]
    3 axis accelerometer measuring 7 day Activity behavior

Other Outcome Measures:
  1. Radiographs [ Time Frame: 10 years ]
    AP, HKA, patella

  2. RSA [ Time Frame: 10 years ]
    radiostereometric analysis 60 patients

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients under the age of 80
  • Both gender
  • Primary osteoarthritis
  • BMI ≤ 35

Exclusion Criteria:

  • Patient over the age of 80
  • Other diagnoses than primary osteoarthritis
  • BMI >35
  • ASA 4 patients (American Society of Anesthesiologists)

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 identifier (NCT number): NCT03548792

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Helse Bergen, Kysthospitalet i Hagavik
Hagavik, Norway, 5217
Sponsors and Collaborators
Helse-Bergen HF
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Study Director: Ove Furnes, Professor Helse Bergen, Norwegian Arthroplasty Register

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Responsible Party: Mona Badawy, Head of knee surgery, Haukeland University Hospital Identifier: NCT03548792     History of Changes
Other Study ID Numbers: 471106
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Mona Badawy, Haukeland University Hospital:
Arthroplasty Knee

Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases