Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT03059927 |
Date of registration:
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16/02/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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The Effect of Three Prosthesis Designs in Total Knee Arthroplasty
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Scientific title:
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The Effect of Three Prosthesis Designs on Implant Stability and Survival, Knee Function, and Clinical Course in Knee Arthroplasty: a Randomized Trial |
Date of first enrolment:
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March 1, 2017 |
Target sample size:
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216 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/show/NCT03059927 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Norway
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Contacts
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Name:
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Yasser Rehman, MD |
Address:
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Telephone:
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+4798477583 |
Email:
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yare@lds.no |
Affiliation:
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Name:
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Arild Aamodt, MD, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Lovisenberg Diaconal Hospital, Oslo, Norway |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Primary osteoarthritis
- Non-fixed or fixed varus or valgus deformity less than 15ยบ 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
Age minimum:
45 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Gonarthrosis; Primary
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Degenerative Joint Disease of Knee
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Intervention(s)
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Procedure: Knee arthroplasty, Anterior stabilized
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Procedure: Knee arthroplasty, Cruciate retaining
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Procedure: Knee arthroplasty, Posterior stabilized
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Primary Outcome(s)
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Knee injury and osteoarthritis outcome score (KOOS)
[Time Frame: Pre-operative, 1, 2 and 5 years]
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Secondary Outcome(s)
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Brief Pain Inventory
[Time Frame: Pre-operative, 6 weeks, 3, 12, 24 and 60 months]
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EQ-5D-5L
[Time Frame: Pre-operative, 1, 2 and 5 years]
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Plain anterior posterior radiographs and hip, knee and ankle (HKA) radiographs
[Time Frame: Pre-operative, 3, 12, 24 and 60 months]
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Range of motion (ROM)
[Time Frame: Pre-operative, 6 weeks, 3, 12, 24 and 60 months]
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Oxford knee score (OKS)
[Time Frame: Pre-operative, 1, 2 and 5 years]
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Kinematic radiostereometric analysis (RSA)
[Time Frame: After 12 months]
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Secondary ID(s)
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LovisenbergOrto
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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