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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: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT03059927
Date of registration: 16/02/2017
Prospective Registration: Yes
Primary sponsor: Lovisenberg Diakonale Hospital
Public title: The Effect of Three Prosthesis Designs in Total Knee Arthroplasty
Scientific title: 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: March 1, 2017
Target sample size: 216
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03059927
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Norway
Contacts
Name:     Yasser Rehman, MD
Address: 
Telephone: +4798477583
Email: yare@lds.no
Affiliation: 
Name:     Arild Aamodt, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Lovisenberg Diaconal Hospital, Oslo, Norway
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Gonarthrosis; Primary
Degenerative Joint Disease of Knee
Intervention(s)
Procedure: Knee arthroplasty, Anterior stabilized
Procedure: Knee arthroplasty, Cruciate retaining
Procedure: Knee arthroplasty, Posterior stabilized
Primary Outcome(s)
Knee injury and osteoarthritis outcome score (KOOS) [Time Frame: Pre-operative, 1, 2 and 5 years]
Secondary Outcome(s)
Brief Pain Inventory [Time Frame: Pre-operative, 6 weeks, 3, 12, 24 and 60 months]
EQ-5D-5L [Time Frame: Pre-operative, 1, 2 and 5 years]
Plain anterior posterior radiographs and hip, knee and ankle (HKA) radiographs [Time Frame: Pre-operative, 3, 12, 24 and 60 months]
Range of motion (ROM) [Time Frame: Pre-operative, 6 weeks, 3, 12, 24 and 60 months]
Oxford knee score (OKS) [Time Frame: Pre-operative, 1, 2 and 5 years]
Kinematic radiostereometric analysis (RSA) [Time Frame: After 12 months]
Secondary ID(s)
LovisenbergOrto
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Haugesund Rheumatism Hospital
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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