Femoral Component TKA: Extramedullary vs Conventional Intramedullary Guide
ConditionTotal Knee Replacement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial 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.
Trial design
Design model
Case-control
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 2 trial groupsGroup A: Extramedullary (EM) guides: Retroprospective + Prospective cohort
Group B: intramedullary (IM) guides: Retrospective cohort
Trial outcomes
Primary outcomes
1
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)
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.Secondary outcomes
1
Results across study centres
Radiographic angles compared between the centres (at pre-op, surgery and 3 month post-op)
Time frame
Compare the results in terms of radiographic sagittal angle between study centres at pre-op, surgery and 3 month post-op.2
Adverse Events to determinate Instrument safety
Number of: adverse events, adverse device effects, serious adverse events and serious adverse device effects
Time frame
During surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov