Total Knee ReplacementEMAX (L2055)NCT07815080
Femoral Component TKA: Extramedullary vs Conventional Intramedullary Guide
An observational study of Total Knee Replacement, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 3 sites in Italy.
Trial summary
The study wants to evaluate the performance of this EM guide in comparison to a traditional IM guide. 75 patients will be included in the extramedullary group (to be compared with a corresponding previous group of 75 patients treated with intramedullary guide). 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
- 150 participants
- Where
- 3 sitesItaly
- Study dates
- 15 Oct 2025to 31 Oct 2027
- 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: The study shall include a total of 150 patients: 75 will be included in the extramedullary group, to be compared with a corresponding previous group of 75 patients treated with intramedullary guide. Patients meeting the inclusion criteria (mentioned below) will be recruited separately by each participating institution. Patient enrolled in the retrospective analysis have been operated upon between January 2021 and September 2025.
Who may be able to join
- Male or female ≥ 18 years old
- Indication to primary TKA, for any diagnosis operated with EM or IM guides
- Signature of the informed consent (only for prospective cohort)
- Been operated upon between January 2021 and September 2025 (only for retrospective cohort)
Who cannot join
- Revision surgery of knee arthroplasty
- Patients with malignant diseases (at the time of surgery)
- Patients with proven or suspect infections (at the time of surgery)
- Pregnancy end/or lactating (auto declaration)
- Patient with known allergy to the specific metallic components of the prosthesis (at the time of surgery)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Laura Mangiavini contact
Italy3 sites, 1 recruiting
- Completed
Istituto Clinico San Siro
Milan, 20148
- Recruiting
IRCCS Ospedale Galeazzi-Sant'Ambrogio [coordinator]
Milan, 20157
Zacchetti, 0283502227 ext. 0039, sara.zacchetti@grupposandonato.it
- Completed
Ospedale Cottolengo
Torino, 10152
About this study
Official title: Positioning Femoral Component TKA Using an Extramedullary Guide: Comparison With Conventional Intramedullary Guide
The study wants to evaluate the performance of this EM guide in comparison to a traditional IM guide.
75 patients will be included in the extramedullary group (to be compared with a corresponding previous group of 75 patients treated with intramedullary guide).
Read the detailed description
Total Knee Arthroplasty (TKA) is a widely performed surgical procedure aimed at relieving pain and restoring function in patients with advanced knee arthritis. The success of TKA is contingent upon precise implant positioning, particularly in relation to the femoral component. The femoral component's alignment significantly influences postoperative knee biomechanics, patient satisfaction, and long-term implant survival.
Conventional methods for femoral component positioning involve the use of intramedullary (IM) guides, which are inserted into the femoral canal to align the cutting block for bone preparation. While IM guides offer precise alignment, they can also lead to complications such as intraoperative fractures, fat embolism, activation of coagulation and excessive blood loss.
To address these limitations, extramedullary (EM) guides have emerged as an alternative option. EM guides are placed on the external surface of the femur without entering the medullary canal and avoiding complications that may occur reaming the canal.
In the recent past years, kinematic alignment (KA) has become widespread in use as a new technique for TKR that considers the patient's individual alignment and biomechanics. By restoring the pre-arthritic kinematic axes of the femur and tibia, KA aims to mimic the natural knee joint's function and movement.
In this study a specific EM guide - Anterior Cortex Stylus - is used to address the alignment of the femoral component in the context of a KA approach. The guide uses the anterior cortex of the distal femur as reference for cutting block positioning. The study aims to evaluate the performance of this EM guide in comparison to a traditional IM guide (used in previous group of patients).
This is an open, multi-centre, retro-prospective, observational, controlled study.
The primary aim is to evaluate whether the Anterior Cortex Stylus (in a retro-prospective collected series) is not inferior to the traditional intramedullary guide (previous group of patients) in term of positioning of the femoral component in TKA.
A total of 75 patients will be included in the extramedullary group (to be compared with a corresponding previous group of 75 patients treated with intramedullary guide). Both groups will be treated with a total knee arthroplasty using GMK Sphere (CE marked, class III) and a kinematic alignment approach.
- Conditions
- Total Knee Replacement
- Keywords
- Total Knee Replacement, Extramidollary Guide, Intramedullary Guide
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 |
|---|---|---|
| Extramedullary (EM) guides: Retroprospective + Prospective cohort | patients trated with extramedullary (EM) guides. This cohort can be both Retroprospective and Prospective | |
| intramedullary (IM) guides: Retrospective cohort | patients trated with intramedullary (IM) guides. This cohort will be only Retrospective |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior Cortex Stylus
Radiographic angle at 3 moth post-op of the femoral component in TKA in an Anterior Cortex Stylus (retro-prospective collected series) compared to intramedullary guide (previous group of patients)
Measured: Radiographic angle at 3 moth post-op in the sagittal plane, between the anterior cortex of the distal femur and the femoral component and compare it in the group operated with Anterior Cortex Stylus versus the group operated with IM guide.
Secondary outcomes (2)
Results across study centres
Radiographic angles compared between the centres (at pre-op, surgery and 3 month post-op)
Measured: Compare the results in terms of radiographic sagittal angle between study centres at pre-op, surgery and 3 month post-op.
Adverse Events to determinate Instrument safety
Number of: adverse events, adverse device effects, serious adverse events and serious adverse device effects
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start15 Oct 2025
- Primary completion15 Oct 2027 (estimated)
- Study completion31 Oct 2027 (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.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corrado Sosio, Principal investigator, Ospedale Galeazzi S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815080
- Sponsor's protocol ID
- EMAX (L2055)
- Acronym
- EMAX (L2055)
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 11 Sep 2026
- 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positioning Femoral Component TKA Using an Extramedullary Guide: Comparison With Conventional Intramedullary Guide
- ClinicalTrials.gov ID
- NCT07815080
- Acronym / sponsor ID
- EMAX (L2055) / EMAX (L2055)
- Conditions
- Total Knee Replacement
- Keywords
- Total Knee Replacement, Extramidollary Guide, Intramedullary Guide
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 11 Sep 2026 (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 study wants to evaluate the performance of this EM guide in comparison to a traditional IM guide.
75 patients will be included in the extramedullary group (to be compared with a corresponding previous group of 75 patients treated with intramedullary guide).
Detailed description
Total Knee Arthroplasty (TKA) is a widely performed surgical procedure aimed at relieving pain and restoring function in patients with advanced knee arthritis. The success of TKA is contingent upon precise implant positioning, particularly in relation to the femoral component. The femoral component's alignment significantly influences postoperative knee biomechanics, patient satisfaction, and long-term implant survival.
Conventional methods for femoral component positioning involve the use of intramedullary (IM) guides, which are inserted into the femoral canal to align the cutting block for bone preparation. While IM guides offer precise alignment, they can also lead to complications such as intraoperative fractures, fat embolism, activation of coagulation and excessive blood loss.
To address these limitations, extramedullary (EM) guides have emerged as an alternative option. EM guides are placed on the external surface of the femur without entering the medullary canal and avoiding complications that may occur reaming the canal.
In the recent past years, kinematic alignment (KA) has become widespread in use as a new technique for TKR that considers the patient's individual alignment and biomechanics. By restoring the pre-arthritic kinematic axes of the femur and tibia, KA aims to mimic the natural knee joint's function and movement.
In this study a specific EM guide - Anterior Cortex Stylus - is used to address the alignment of the femoral component in the context of a KA approach. The guide uses the anterior cortex of the distal femur as reference for cutting block positioning. The study aims to evaluate the performance of this EM guide in comparison to a traditional IM guide (used in previous group of patients).
This is an open, multi-centre, retro-prospective, observational, controlled study.
The primary aim is to evaluate whether the Anterior Cortex Stylus (in a retro-prospective collected series) is not inferior to the traditional intramedullary guide (previous group of patients) in term of positioning of the femoral component in TKA.
A total of 75 patients will be included in the extramedullary group (to be compared with a corresponding previous group of 75 patients treated with intramedullary guide). Both groups will be treated with a total knee arthroplasty using GMK Sphere (CE marked, class III) and a kinematic alignment approach.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extramedullary (EM) guides: Retroprospective + Prospective cohort | – | –patients trated with extramedullary (EM) guides. This cohort can be both Retroprospective and Prospective |
| intramedullary (IM) guides: Retrospective cohort | – | –patients trated with intramedullary (IM) guides. This cohort will be only Retrospective |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study shall include a total of 150 patients: 75 will be included in the extramedullary group, to be compared with a corresponding previous group of 75 patients treated with intramedullary guide. Patients meeting the inclusion criteria (mentioned below) will be recruited separately by each participating institution. Patient enrolled in the retrospective analysis have been operated upon between January 2021 and September 2025.
Key inclusion criteria (4 listed)
- Male or female ≥ 18 years old
- Indication to primary TKA, for any diagnosis operated with EM or IM guides
- Signature of the informed consent (only for prospective cohort)
- Been operated upon between January 2021 and September 2025 (only for retrospective cohort)
Key exclusion criteria (5 listed)
- Revision surgery of knee arthroplasty
- Patients with malignant diseases (at the time of surgery)
- Patients with proven or suspect infections (at the time of surgery)
- Pregnancy end/or lactating (auto declaration)
- Patient with known allergy to the specific metallic components of the prosthesis (at the time of surgery)
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
Anterior Cortex Stylus
Time frame: Radiographic angle at 3 moth post-op in the sagittal plane, between the anterior cortex of the distal femur and the femoral component and compare it in the group operated with Anterior Cortex Stylus versus the group operated with IM guide.
Radiographic angle at 3 moth post-op of the femoral component in TKA in an Anterior Cortex Stylus (retro-prospective collected series) compared to intramedullary guide (previous group of patients)
2 secondary outcomes
Results across study centres
Time frame: Compare the results in terms of radiographic sagittal angle between study centres at pre-op, surgery and 3 month post-op.
Adverse Events to determinate Instrument safety
Time frame: During surgery
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 11 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Persona SoluTion PPS Femur PMCF
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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.
Laura Mangiavini contact
Corrado Sosio principal investigator
Ospedale Galeazzi S.p.A.
3 sites 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 I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 3 sites in Italy.
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 4 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
Contact Sara Zacchetti (0283502227 ext. 0039, sara.zacchetti@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior Cortex Stylus (time frame: Radiographic angle at 3 moth post-op in the sagittal plane, between the anterior cortex of the distal femur and the femoral component and compare it in the group operated with Anterior Cortex Stylus versus the group operated with IM guide.). 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 11 Sep 2026.