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The Effect of Three Prosthesis Designs in Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03059927
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : April 20, 2017
Sponsor:
Collaborator:
Haugesund Rheumatism Hospital
Information provided by (Responsible Party):
Lovisenberg Diakonale Hospital

Brief Summary:
The purpose of this study is to compare three prosthesis designs to compare three prosthesis designs for total knee arthroplasty and determine the best option for patients in need of a knee replacement.

Condition or disease Intervention/treatment Phase
Gonarthrosis; Primary Degenerative Joint Disease of Knee Procedure: Knee arthroplasty, Cruciate retaining Procedure: Knee arthroplasty, Anterior stabilized Procedure: Knee arthroplasty, Posterior stabilized Not Applicable

Detailed Description:
Total knee arthroplasty (TKA) is a cost beneficial surgery shown to improve pain, function and quality of life in patients with osteoarthritis. In 2015, 6093 patients received primary TKA in Norway. Despite the procedure´s general success, 20% of patients report persistent postoperative pain and/or dissatisfaction with the surgical outcome. Efforts to further improve the procedure have raised considerable debate regarding the role and management of the posterior cruciate ligament (PCL). Prostheses for TKA have evolved into designs that either preserve or sacrifice the PCL. In patients with a functional PCL, the decision of which design is selected depends largely on the favor and training of the surgeon. To further improve TKA patient outcomes, a better understanding of the role of these differing PCL treatments is needed. Thus, the aim of this study is to determine whether patients' perceived outcome, implant stability and clinical outcome differ between 3 TKA implant designs (2 PCL-sacrificing and 1 PCL-retaining). We will conduct a 3-arm randomized controlled prospective trial with 5-year follow-up. This study will have impact on clinical practice by addressing the lack of evidence supporting use of these different types of implants.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Three Prosthesis Designs on Implant Stability and Survival, Knee Function, and Clinical Course in Knee Arthroplasty: a Randomized Trial
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Knee arthroplasty, Cruciate retaining
Total knee replacement with preserved posterior cruciate ligament and a cruciate retaining insert.
Procedure: Knee arthroplasty, Cruciate retaining
Legion total knee arthroplasty implant component, Smith & Nephew, Cruciate Retaining design

Active Comparator: Knee arthroplasty, Anterior stabilized
Total knee replacement with sacrificed posterior cruciate ligament and an anterior stabilized insert.
Procedure: Knee arthroplasty, Anterior stabilized
Legion total knee arthroplasty implant component, Smith & Nephew, Anterior Stabilized design

Active Comparator: Knee arthroplasty, Posterior stabilized
Total knee replacement with sacrificed posterior cruciate ligament and a posterior stabilized design.
Procedure: Knee arthroplasty, Posterior stabilized
Legion total knee arthroplasty implant component, Smith & Nephew, Posterior Stabilized design




Primary Outcome Measures :
  1. Knee injury and osteoarthritis outcome score (KOOS) [ Time Frame: Pre-operative, 1, 2 and 5 years ]
    KOOS is a knee-specific questionnaire developed to evaluate short- and long-term symptoms and functioning in subjects with knee injury and osteoarthritis. KOOS is validated for use in total knee arthroplasty and has been shown to be a valid, reliable and responsive measure. KOOS is a patient-administered questionnaire.


Secondary Outcome Measures :
  1. Oxford knee score (OKS) [ Time Frame: Pre-operative, 1, 2 and 5 years ]
    OKS is a brief patient-completed questionnaire for patients undergoing total knee arthroplasty. It reflects the patient's assessment of their knee-related health status and benefits of treatment.

  2. EQ-5D-5L [ Time Frame: Pre-operative, 1, 2 and 5 years ]
    EQ-5D-5L is a widely-used patient-administered instrument for describing health-related quality of life

  3. Range of motion (ROM) [ Time Frame: Pre-operative, 6 weeks, 3, 12, 24 and 60 months ]
    ROM will be measured by extension and flexion with a goniometer preoperatively at baseline and at each follow-up visit (6 weeks, 3 months, 12 months, 24 months and 60 months

  4. Kinematic radiostereometric analysis (RSA) [ Time Frame: After 12 months ]
    Knee motion while walking up and down stairs, and during squatting and kneeling activities will be recorded using video fluoroscopy (dynamic RSA) at 12 months.

  5. Plain anterior posterior radiographs and hip, knee and ankle (HKA) radiographs [ Time Frame: Pre-operative, 3, 12, 24 and 60 months ]
    Radiographs obtained for assessment of fixation of the prosthesis and the alignment.

  6. Brief Pain Inventory [ Time Frame: Pre-operative, 6 weeks, 3, 12, 24 and 60 months ]
    We will use three single items to measure worst pain intensity, average pain intensity, and pain interference with walking. Patients rate their pain intensity and pain interference with walking on an 11-point numeric rating scale from 0-10, where 0=no pain/no interference and 10=worst imaginable pain/complete interference.



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary osteoarthritis
  • Non-fixed or fixed varus or valgus deformity less than 15º measured on preoperative standing hip-knee-ankle (HKA) radiographs
  • Intact PCL (assessed preoperatively and verified during surgery)
  • Age 45 - 75 years (only patients 45 - 70 years will be included in the kinematic RSA)
  • Body mass index ≤ 35 kg/m2
  • ASA (American Society of Anaesthesiologists) score I or II
  • Only patients with KOOS scores above 80 on the Symptoms, ADL (Activities of Daily Living) and Pain subscales will be included in the kinematic analysis

Exclusion Criteria:

  • Prior ACL (anterior cruciate ligament) surgery
  • Impaired collateral ligaments
  • Secondary osteoarthritis of the knee
  • Previous osteotomy
  • Rheumatic disease
  • Flexion less than 90 degrees
  • Flexion contracture over 10 degrees
  • Peripheral neuropathy
  • Malignancy
  • Patients who do not speak Norwegian

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): NCT03059927


Contacts
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Contact: Yasser Rehman, MD +4798477583 yare@lds.no

Locations
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Norway
Haugesund Rheumatism Hospital Not yet recruiting
Haugesund, Norway, 5528
Contact: Øystein Gøthesen, Md, PhD    988 08162      
Lovisenberg Diaconal Hospital Recruiting
Oslo, Norway, 0446
Contact: Arild Aamodt, MD, PhD       aara@lds.no   
Principal Investigator: Yasser Rehman, MD         
Sponsors and Collaborators
Lovisenberg Diakonale Hospital
Haugesund Rheumatism Hospital
Investigators
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Study Director: Arild Aamodt, MD, PhD Lovisenberg Diaconal Hospital, Oslo, Norway

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Responsible Party: Lovisenberg Diakonale Hospital
ClinicalTrials.gov Identifier: NCT03059927     History of Changes
Other Study ID Numbers: LovisenbergOrto
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: February 2017
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 Lovisenberg Diakonale Hospital:
Cruciate retaining
Anterior stabilized
Posterior stabilized
Posterior cruciate ligament
Degenerative knee joint disease
Knee injury and Osteoarthritis Outcome Score
Kinematic radiostereometry

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