Total Knee ReplacementKAvsMANCT04384913
Kinematic Versus Mechanical Alignment in Total Knee Replacement
An observational study of Total Knee Replacement, run by Hannover Medical School at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2017to 30 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inclusion Criteria: * Symptomatic osteoarthritis of the knee * Primary TKA * UCLA>/= 4 * mMPTA: 85°- 90° * Sum of mMPTA and mLDFA 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
Hanover, Lower Saxony, 30625
About this study
Official title: Kinematic Versus Mechanical Alignment in Total Knee Replacement: a Randomized Double-blinded Controlled Study
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.
Read the detailed 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.
- Conditions
- Total Knee Replacement
- Keywords
- TKA (Total knee arthroplasty), KA (kinematic alignment)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MA (mechanical alignment) | Patients in group MA (mechanical alignment) will be operated according to mechanical implantation technique. In the mechanical group, femoral and tibial cutting blocks will be designed for a 0-degree angle according to the mechanical axis. Femoral rotation will be aligned with the femoral trans-epicondylar axis. Tibial rotation will follow femoral rotation. | |
| KA (kinematic alignment) | Patients in group KA (kinematic alignment) will be operated according to kinematic implantation technique. The kinematic cutting blocks will be designed to resurface the femoral and tibial bones to restore each patient´s pre-arthritic anatomy and Joint line. Based on a available CT dat the prearthritic anatomy is reconstructed by compensating bone defects and restoring the physiological cartilage height of 1,7mm. Femoral Flexion is evaluated by the anterior Cortex of the distal femur, tibia slope is defined to 3° due to ACL (Anterior Cruciate Ligament) loss, but cab be adapted during surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 24 months postoperative
Secondary outcomes (9)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Aug 2017
- Primary completion23 Sep 2022
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Max Ettinger, Prof. Dr., Principal investigator, Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384913
- Sponsor's protocol ID
- A2-2017-KAvsMA
- Acronym
- KAvsMA
- Status last verified
- Mar 2025
- First submitted
- 28 Apr 2020
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinematic Versus Mechanical Alignment in Total Knee Replacement: a Randomized Double-blinded Controlled Study
- ClinicalTrials.gov ID
- NCT04384913
- Acronym / sponsor ID
- KAvsMA / A2-2017-KAvsMA
- Conditions
- Total Knee Replacement
- Keywords
- TKA (Total knee arthroplasty), KA (kinematic alignment)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MA (mechanical alignment) | – | –Patients in group MA (mechanical alignment) will be operated according to mechanical implantation technique. In the mechanical group, femoral and tibial cutting blocks will be designed for a 0-degree angle according to the mechanical axis. Femoral rotation will be aligned with the femoral trans-epicondylar axis. Tibial rotation will follow femoral rotation. |
| KA (kinematic alignment) | – | –Patients in group KA (kinematic alignment) will be operated according to kinematic implantation technique. The kinematic cutting blocks will be designed to resurface the femoral and tibial bones to restore each patient´s pre-arthritic anatomy and Joint line. Based on a available CT dat the prearthritic anatomy is reconstructed by compensating bone defects and restoring the physiological cartilage height of 1,7mm. Femoral Flexion is evaluated by the anterior Cortex of the distal femur, tibia slope is defined to 3° due to ACL (Anterior Cruciate Ligament) loss, but cab be adapted during surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion Criteria: * Symptomatic osteoarthritis of the knee * Primary TKA * UCLA>/= 4 * mMPTA: 85°- 90° * Sum of mMPTA and mLDFA 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Minor Patient
- Pregnant or breast feeding woman
- Difference in the radius of medial and lateral condyles >2mm
- Previous osteotomy around the knee
- BMI >40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Knee Society Score (KSS)
Time frame: 3 months postoperative
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)
Knee Society Score (KSS)
Time frame: 12 months postoperative
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)
Knee Society Score (KSS)
Time frame: 24 months postoperative
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)
9 secondary outcomes
Forgotten Joint Score (FJS-12)
Time frame: 3 months postoperative
Forgotten Joint Score (FJS-12)
Time frame: 12 months postoperative
Forgotten Joint Score (FJS-12)
Time frame: 24 months postoperative
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 3 months postoperative
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 12 months postoperative
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 24 months postoperative
Oxford Knee Score (OKS)
Time frame: 3 months postoperative
Oxford Knee Score (OKS)
Time frame: 12 months postoperative
Oxford Knee Score (OKS)
Time frame: 24 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Total Knee Replacement
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max Ettinger, Prof. Dr. principal investigator
Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Replacement, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Society Score (KSS) (time frame: 3 months postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.