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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
216
Legion total knee arthroplasty implant component, Smith \& Nephew, Cruciate Retaining design
Legion total knee arthroplasty implant component, Smith \& Nephew, Anterior Stabilized design
Legion total knee arthroplasty implant component, Smith \& Nephew, Posterior Stabilized design
Haugesund Rheumatism Hospital
Haugesund, Norway
NOT_YET_RECRUITINGLovisenberg Diaconal Hospital
Oslo, Norway
RECRUITINGKnee injury and osteoarthritis outcome score (KOOS)
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.
Time frame: Pre-operative, 1, 2 and 5 years
Oxford knee score (OKS)
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.
Time frame: Pre-operative, 1, 2 and 5 years
EQ-5D-5L
EQ-5D-5L is a widely-used patient-administered instrument for describing health-related quality of life
Time frame: Pre-operative, 1, 2 and 5 years
Range of motion (ROM)
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
Time frame: Pre-operative, 6 weeks, 3, 12, 24 and 60 months
Kinematic radiostereometric analysis (RSA)
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.
Time frame: After 12 months
Plain anterior posterior radiographs and hip, knee and ankle (HKA) radiographs
Radiographs obtained for assessment of fixation of the prosthesis and the alignment.
Time frame: Pre-operative, 3, 12, 24 and 60 months
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Brief Pain Inventory
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.
Time frame: Pre-operative, 6 weeks, 3, 12, 24 and 60 months