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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||216 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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
- 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.
- 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.
- 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
- 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
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059927
|Contact: Yasser Rehman, MDfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Yasser Rehman, MD|
|Study Director:||Arild Aamodt, MD, PhD||Lovisenberg Diaconal Hospital, Oslo, Norway|