Osteoarthritis, KneeNCT03446391
Matched Pair Study - Kinematic Vs Mechanical Alignment
An observational study of Osteoarthritis, Knee and Joint Disease, run by Medacta International SA at 1 site in Germany.
Trial summary
The aim of this study is to evaluate postoperative knee function after total knee arthroplasty performed according to the anatomical alignment and compare these results to those of a matched historical cohort of patients operated with mechanical alignment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Knee, Joint Disease
- What is being tested?
- Kinematic alignment, Mechanical alignment and GMK Sphere®
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 2 Jan 2018to 18 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients will be recruited during the preoperative visit at the investigational site. All patients scheduled for a total knee replacements, meeting the inclusion criteria and none of the exclusion criteria will be invited to the study.
Who may be able to join
- Patients presenting with disease that meets the indications for use for Medacta implants defined by this study (on-label use).
- Patients necessitating primary Total Knee Replacement
- Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.
Who cannot join
- Those with one or more medical conditions identified as a contraindication defined by the labeling on Medacta implants used in this study.
- Previous osteotomy around the knee
- Ligament instability likely to require higher level of constraint
- Previous infection or inflammatory disease
- Extraarticular deformities for which a femoral intramedullary guide rod can't be inserted into the canal and use of Computer Assisted Orthopaedic Surgery (CAOS) or Patient Specific Instrumentation (PSI) is required.
Trial locations and contacts
1 site in 1 country.
Germany1 site
St. Vinzenz Krankenhaus Brakel
Brakel, North Rhine-Westphalia, 33034
About this study
Official title: Matched Pair Study to Assess Influence of Kinematic Versus Mechanical Alignment in Total Knee Replacement
The aim of this study is to evaluate postoperative knee function after total knee arthroplasty performed according to the anatomical alignment and compare these results to those of a matched historical cohort of patients operated with mechanical alignment.
Read the detailed description
The 25 patients, of the Kinematic group, are prospectively enrolled. While, the data of patients of the Mechanical group, are retrospectively collected from an historical collection.
- Conditions
- Osteoarthritis, Knee, Joint Disease
- Being tested
- Kinematic alignment, Mechanical alignment, GMK Sphere®
- Medical subject headings
- Osteoarthritis, Knee, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinematic alignmentProcedure or surgery
The principle for kinematically aligning the femoral component is to remove the correct amount of bone and cartilage from the distal and posterior femur after accounting for wear and saw blade kerf, so that the total thickness of the missing and removed tissue matches the thickness of the femoral component.
Mechanical alignmentProcedure or surgery
Classic mechanical alignment (MA) in total knee arthroplasty (TKA) is meant to co-align the prosthetic components to the mechanical axes of the femur and tibia and restore neutral overall limb alignment
GMK Sphere®Device
The GMK Sphere® is a total knee prosthesis . The design of the GMK Sphere® is characterized by a spherical medial femoral condyle and an asymmetrical fixed tibial UHMWPE polyethylene insert with a concave spherical medial compartment.
| Study group | Role | What they receive |
|---|---|---|
| Kinematic alignment with GMK Sphere® | Patients enrolled prospectively with surgeries planned to get kinematic alignment Receives: Procedure: Kinematic alignment; Device: GMK Sphere® | |
| Mechanical alignment with GMK Sphere® | Historical group who had mechanical alignment, match-paired with the prospective group Receives: Procedure: Mechanical alignment; Device: GMK Sphere® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare clinical outcomes of mechanical vs kinematic with new Knee Society Score
The new KSS (from the publication of 2011, Giles R. Scuderi MD "The New Knee Society Knee Scoring System" Clin Orthop Relat Res (2012) 470:3-19) includes a part filled by the surgeon and one by the patient. The first outcome is focused on the "Functional Activities" subscore, excluding the "Discretionary knee activities". The maximum is 85 points while the minimum is -10 points. The "Functional Activities" score includes 3 subscores: WALKING AND STANDING (min -10, max 30), STANDARD ACTIVITIES (min 0, max 30) and ADVANCED ACTIVITIES (min 0, max 25)
Measured: 1-year follow-up
Secondary outcomes (5)
Patient functional improvement, satisfaction and symptoms
The functional improvement, satisfaction and symptoms is the sum of the following subscores of the new KSS: "Functional Activities", "Patient Satisfaction" and "Symptoms"
Measured: 1-year follow-up
Residual deformity
The residual deformity is evaluated by long axis Xray analysis: HKA angle
Measured: 1-year follow-up
Flexion-extension contracture
The flexion-extension contracture is evaluated by a subscore of the new KSS: "Joint motion"
Measured: 1-year follow-up
Self-reported pain, function and stiffness
These aspects are evaluated through KOOS score
Measured: 1-year follow-up
Ability to forget about artificial joint
Through the use of the Forgotten Joint Score
Measured: 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start2 Jan 2018
- Primary completion18 May 2019
- Study completion18 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Other
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446391
- Sponsor's protocol ID
- P02.010.18
- Status last verified
- Mar 2019
- First submitted
- 19 Feb 2018
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Matched Pair Study to Assess Influence of Kinematic Versus Mechanical Alignment in Total Knee Replacement
- ClinicalTrials.gov ID
- NCT03446391
- Acronym / sponsor ID
- P02.010.18
- Conditions
- Osteoarthritis, Knee, Joint Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 18 May 2019 (actual)
- Study completion
- 18 May 2019 (actual)
- First posted
- 26 Feb 2018 (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.
The aim of this study is to evaluate postoperative knee function after total knee arthroplasty performed according to the anatomical alignment and compare these results to those of a matched historical cohort of patients operated with mechanical alignment.
Detailed description
The 25 patients, of the Kinematic group, are prospectively enrolled. While, the data of patients of the Mechanical group, are retrospectively collected from an historical collection.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinematic alignment with GMK Sphere® | – | Procedure: Kinematic alignment, Device: GMK Sphere®Patients enrolled prospectively with surgeries planned to get kinematic alignment |
| Mechanical alignment with GMK Sphere® | – | Procedure: Mechanical alignment, Device: GMK Sphere®Historical group who had mechanical alignment, match-paired with the prospective group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be recruited during the preoperative visit at the investigational site. All patients scheduled for a total knee replacements, meeting the inclusion criteria and none of the exclusion criteria will be invited to the study.
Key inclusion criteria (3 listed)
- Patients presenting with disease that meets the indications for use for Medacta implants defined by this study (on-label use).
- Patients necessitating primary Total Knee Replacement
- Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.
Key exclusion criteria (5 listed)
- Those with one or more medical conditions identified as a contraindication defined by the labeling on Medacta implants used in this study.
- Previous osteotomy around the knee
- Ligament instability likely to require higher level of constraint
- Previous infection or inflammatory disease
- Extraarticular deformities for which a femoral intramedullary guide rod can't be inserted into the canal and use of Computer Assisted Orthopaedic Surgery (CAOS) or Patient Specific Instrumentation (PSI) is required.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinematic alignmentThe principle for kinematically aligning the femoral component is to remove the correct amount of bone and cartilage from the distal and posterior femur after accounting for wear and saw blade kerf, so that the total thickness of the missing and removed tissue matches the thickness of the femoral component. | Procedure or surgery | Kinematic alignment with GMK Sphere® |
| Mechanical alignmentClassic mechanical alignment (MA) in total knee arthroplasty (TKA) is meant to co-align the prosthetic components to the mechanical axes of the femur and tibia and restore neutral overall limb alignment | Procedure or surgery | Mechanical alignment with GMK Sphere® |
| GMK Sphere®The GMK Sphere® is a total knee prosthesis . The design of the GMK Sphere® is characterized by a spherical medial femoral condyle and an asymmetrical fixed tibial UHMWPE polyethylene insert with a concave spherical medial compartment. | Device | Kinematic alignment with GMK Sphere®, Mechanical alignment with GMK Sphere® |
Primary outcome
Compare clinical outcomes of mechanical vs kinematic with new Knee Society Score
Time frame: 1-year follow-up
The new KSS (from the publication of 2011, Giles R. Scuderi MD "The New Knee Society Knee Scoring System" Clin Orthop Relat Res (2012) 470:3-19) includes a part filled by the surgeon and one by the patient. The first outcome is focused on the "Functional Activities" subscore, excluding the "Discretionary knee activities". The maximum is 85 points while the minimum is -10 points. The "Functional Activities" score includes 3 subscores: WALKING AND STANDING (min -10, max 30), STANDARD ACTIVITIES (min 0, max 30) and ADVANCED ACTIVITIES (min 0, max 25)
5 secondary outcomes
Patient functional improvement, satisfaction and symptoms
Time frame: 1-year follow-up
Residual deformity
Time frame: 1-year follow-up
Flexion-extension contracture
Time frame: 1-year follow-up
Self-reported pain, function and stiffness
Time frame: 1-year follow-up
Ability to forget about artificial joint
Time frame: 1-year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteoarthritis, Knee and Joint Disease, run by Medacta International SA 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 16 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare clinical outcomes of mechanical vs kinematic with new Knee Society Score (time frame: 1-year follow-up). 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 16 Dec 2024; AzTrials last refreshed its copy on 27 Oct 2026.