Kinematic Versus Mechanical Alignment in Total Knee Replacement

Total Knee Replacement Clinical Trial

— KAvsMA  

Official title:

Kinematic Versus Mechanical Alignment in Total Knee Replacement: a Randomized Double-blinded Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04384913
• Other study ID #: A2-2017-KAvsMA
• Status: Active, not recruiting
• Start date: August 1, 2017
• Est. completion date: January 30, 2026

Study information

• Verified date: March 2023
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: January 30, 2026
• Est. primary completion date: September 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Symptomatic osteoarthritis of the knee
• Primary TKA
• UCLA Score (University of California, Los Angeles Score)>/= 4
• mMPTA: 85°- 90°
• Sum of mMPTA(mechanical medial proximal tibial angle) and mLDFA(mechanical lateral distal femoral angle) between 3°varus and 2°valgus from neutral

Exclusion Criteria:

• Minor Patient
• Pregnant or breast feeding woman
• Difference in the radius of medial and lateral condyles >2mm
• Previous osteotomy around the knee
• BMI >40
• Ligament instability likely to require higher level of constraint
• Previous infection or inflammatory disease
• Any Patient who cannot or will not provide informed consent for participation in the study

Related Conditions & MeSH terms

• Total Knee Replacement

Locations

Country	Name	City	State
Germany	Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift	Hanover	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	3 months postoperative
Primary	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)	12 months postoperative
Primary	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)	24 months postoperative
Secondary	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)	3 months postoperative
Secondary	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)	12 months postoperative
Secondary	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)	24 months postoperative
Secondary	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)	3 months postoperative
Secondary	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)	12 months postoperative
Secondary	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)	24 months postoperative
Secondary	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.	3 months postoperative
Secondary	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.	12 months postoperative
Secondary	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.	24 months postoperative