This prospective controlled double-blind randomized study compares kinematic and mechanical alignment in TKA (Total knee arthroplasty). A total of 120 patients will be included and the surgery will be performed using CT based 3D printed PSI(Patient Specific Instruments) Cutting guides.
Total knee arthroplasty (TKA) is known, to significantly improve function and satisfaction in arthritic knee patients; nevertheless, a substantial percentage of these patients are not fully satisfied. Thus, several authors reported significantly improved outcomes after slightly under correcting varus knees after TKA. The concept of kinematic alignment (KA) even more addresses the patient´s individual anatomy with three-dimensional restoration of individual axes, joint lines and joint envelope of laxity. The aim of this prospective randomized study was to demonstrate equivalence between mechanical and kinematic alignment in restoring knee function in terms of subjective and objective outcomes. In this prospective randomized controlled double-blind study 120 patients with osteoarthritic knees will be treated with a Medial Pivot TKA (Medacta Sphere GMK). The patients are divided into two groups. Group A receive the TKA using mechanical alignment principles, group B receive the kinematic alignment. The surgical technique was equal in both groups. CT-based 3D printed PSI cutting blocks were used for the saw cuts. Pre and postoperative standard x-rays were performed. To determine the subjective and objective outcomes the OKS(Oxford Knee Score), the KSS(Knee Society Sore), the FJS-12(Forgotten Joint Score) and the WOMAC Score were collected.
Study Type
OBSERVATIONAL
Enrollment
130
Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
Hanover, Lower Saxony, Germany
Knee Society Score (KSS)
The Knee Society Scoring System is a validated and responsive method for assessing objective and subjective outcomes after total and partial knee arthroplasty. Minimum: 0 (worst), Maximum: 100 (best)
Time frame: 3 months postoperative
Knee Society Score (KSS)
The Knee Society Scoring System is a validated and responsive method for assessing objective and subjective outcomes after total and partial knee arthroplasty. Minimum: 0 (worst), Maximum: 100 (best)
Time frame: 12 months postoperative
Knee Society Score (KSS)
The Knee Society Scoring System is a validated and responsive method for assessing objective and subjective outcomes after total and partial knee arthroplasty. Minimum: 0 (worst), Maximum: 100 (best)
Time frame: 24 months postoperative
Forgotten Joint Score (FJS-12)
The FJS Knee was designed to assess patient outcome in patients undergoing conservative or operative treatment of the knee. This questionnaire shows its strengths in patients with a good level of knee function and a low pain level. It has been designed specifically to reduce ceiling effects commonly associated with many PRO measures in this patient group, e.g. when assessing short- to mid-term results in total knee arthroplasty patients. Minimum: 0 (worst), Maximum: 100 (best)
Time frame: 3 months postoperative
Forgotten Joint Score (FJS-12)
The FJS Knee was designed to assess patient outcome in patients undergoing conservative or operative treatment of the knee. This questionnaire shows its strengths in patients with a good level of knee function and a low pain level. It has been designed specifically to reduce ceiling effects commonly associated with many PRO measures in this patient group, e.g. when assessing short- to mid-term results in total knee arthroplasty patients. Minimum: 0 (worst), Maximum: 100 (best)
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Time frame: 12 months postoperative
Forgotten Joint Score (FJS-12)
The FJS Knee was designed to assess patient outcome in patients undergoing conservative or operative treatment of the knee. This questionnaire shows its strengths in patients with a good level of knee function and a low pain level. It has been designed specifically to reduce ceiling effects commonly associated with many PRO measures in this patient group, e.g. when assessing short- to mid-term results in total knee arthroplasty patients. Minimum: 0 (worst), Maximum: 100 (best)
Time frame: 24 months postoperative
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC Score was developed in 1982 and is a Patient Reported Outcome (PRO) instrument to assess the effects of osteoarthritis of the hip and/or knee joint in affected patients. The WOMAC-Score contains 24 questions and is able to assess the effects of osteoarthritis of the hip and/or knee joint with regard to three subscales: Pain - 5 questions Stiffness - 2 questions Physical function - 17 questions Minimum: 0 (best), Maximum: 100 (worst)
Time frame: 3 months postoperative
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC Score was developed in 1982 and is a Patient Reported Outcome (PRO) instrument to assess the effects of osteoarthritis of the hip and/or knee joint in affected patients. The WOMAC-Score contains 24 questions and is able to assess the effects of osteoarthritis of the hip and/or knee joint with regard to three subscales: Pain - 5 questions Stiffness - 2 questions Physical function - 17 questions Minimum: 0 (best), Maximum: 100 (worst)
Time frame: 12 months postoperative
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC Score was developed in 1982 and is a Patient Reported Outcome (PRO) instrument to assess the effects of osteoarthritis of the hip and/or knee joint in affected patients. The WOMAC-Score contains 24 questions and is able to assess the effects of osteoarthritis of the hip and/or knee joint with regard to three subscales: Pain - 5 questions Stiffness - 2 questions Physical function - 17 questions Minimum: 0 (best), Maximum: 100 (worst)
Time frame: 24 months postoperative
Oxford Knee Score (OKS)
The OKS questionnaire consists of 12 questions that cover function and pain of the knee. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes. The OKS has a big ceiling effect and cannot differentiate between good and very good results. However, the most of the researchers world wide use the OKS as a reference.
Time frame: 3 months postoperative
Oxford Knee Score (OKS)
The OKS questionnaire consists of 12 questions that cover function and pain of the knee. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes. The OKS has a big ceiling effect and cannot differentiate between good and very good results. However, the most of the researchers world wide use the OKS as a reference.
Time frame: 12 months postoperative
Oxford Knee Score (OKS)
The OKS questionnaire consists of 12 questions that cover function and pain of the knee. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes. The OKS has a big ceiling effect and cannot differentiate between good and very good results. However, the most of the researchers world wide use the OKS as a reference.
Time frame: 24 months postoperative