Knee DiseaseNCT06305858
Partial Versus Total Knee Replacement in Bicompartmental Gonarthrosis (Medial and Patellofemoral): Prospective Functional Assessment Study
A study testing Prosthetic Surgical Procedure in people with Knee Disease, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
The study is, in accordance with current legislation, definable as a prospective single-center interventional randomized study. The aim of the study is to evaluate the post-operative recovery of the group A patient undergoing the partial knee replacement surgical procedure compared to the group B patient undergoing… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Knee Disease
- What is being tested?
- Prosthetic Surgical Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2022to Dec 2025
- Phase
- Interventional
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grade 3-4 sec Kellgren-Lawrence medial gonarthrosis
- Patellar symptoms
- Primary gonarthrosis
- Patients with ligament integrity
- Age between 40 and 85 years inclusive
- Signing of the Informed Consent and consent to cooperate in all study procedures.
Who cannot join
- Cognitive impairment
- Psychiatric disorders
- Neuromuscular disorders
- Age > 85 years and <40 years
- Lateral gonarthrosis grade 4 sec Kellgren-Lawrence
- Secondary medial gonarthrosis
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- Revisions
- Minors
- Pregnant women self-declaration
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Clinico San Siro
Milan
Elena Cittera, 0283502224, elena.cittera@grupposandonato.it
Andrea Parente
About this study
The study is, in accordance with current legislation, definable as a prospective single-center interventional randomized study.
The aim of the study is to evaluate the post-operative recovery of the group A patient undergoing the partial knee replacement surgical procedure compared to the group B patient undergoing the total knee replacement surgical procedure through clinical/functional scores.
Read more
The primary outcome is evaluate the difference in score of the KSS questionnaire, at 1 month after surgery, completed by the patient of group A compared to the patient of group B.
The population consists of 48 adult patients with gonarthrosis divided into two groups:
24 patients Group A experimental group: partial denture surgical procedure
24 patients Group B control group: total denture surgical procedure with patellar resurfacing
Read the detailed description
The medial unicompartmental prosthesis procedure associated with patellofemoral is reserved for active patients suffering from bicompartmental gonarthrosis in which total knee replacement is to be avoided. The advantage for the patient, compared to total prosthesis surgery, consists in the less invasive nature of the surgical gesture, in the total preservation of the cruciate ligaments and the external compartment and therefore of the native joint biomechanics with the possibility of remote revision with total prosthesis from first implant.
Patients keep "their knee" which is coated and not replaced with advantages in terms of joint feedback and functionality in daily activities and sports practices. This study aims to compare two groups of patients suffering from bicompartmental gonarthrosis (medial and patellofemoral gonarthrosis): Group A undergoing a bicompartmental prosthesis surgical procedure; Group B undergoing a total denture surgical procedure with patellar resurfacing. The two groups will be evaluated with clinical and functional scores aimed at evaluating the outcome in the two surgical procedures.
The number and type of exams are as follows:
- Randomization to Group A or Group B (ad hoc)
- Knee replacement surgery (as usual)
- Compilation of KSS questionnaire at 1, 2, 6, 12 months of follow-up with clinical and functional scores (as a matter of practice)
- Questionnaires and scales (WOMAC, Tegner, VAS and patient satisfaction) at 2, 6, 12 months post intervention (as a matter of practice)
- Recording of any adverse events at 1, 2, 6, 12 months after surgery (as a matter of practice)
- Conditions
- Knee Disease
- Being tested
- Prosthetic Surgical Procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic Surgical ProcedureProcedure or surgery
The population consists of 48 patients divided into two groups:
24 patients Group A experimental group: partial denture surgical procedure
24 patients Group B control group: total denture surgical procedure with patellar resurfacing
| Study group | Role | What they receive |
|---|---|---|
| Partial denture surgical procedure | Experimental | Not described Receives: Procedure: Prosthetic Surgical Procedure |
| Total denture surgical procedure with patellar resurfacing | Active comparator | Not described Receives: Procedure: Prosthetic Surgical Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the difference in score of the KSS (Knee Society Score) questionnaire, completed by the patient in group A compared to the patient in group B
Evaluate the difference in score of the KSS questionnaire, at 1 month after surgery, completed by the patient of group A compared to the patient of group B
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Mar 2022
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305858
- Sponsor's protocol ID
- UKA - PFJ
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Versus Total Knee Replacement in Bicompartmental Gonarthrosis (Medial and Patellofemoral): Prospective Functional Assessment Study
- ClinicalTrials.gov ID
- NCT06305858
- Acronym / sponsor ID
- UKA - PFJ
- Conditions
- Knee Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Mar 2024 (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 is, in accordance with current legislation, definable as a prospective single-center interventional randomized study.
The aim of the study is to evaluate the post-operative recovery of the group A patient undergoing the partial knee replacement surgical procedure compared to the group B patient undergoing the total knee replacement surgical procedure through clinical/functional scores.
The primary outcome is evaluate the difference in score of the KSS questionnaire, at 1 month after surgery, completed by the patient of group A compared to the patient of group B.
The population consists of 48 adult patients with gonarthrosis divided into two groups:
24 patients Group A experimental group: partial denture surgical procedure
24 patients Group B control group: total denture surgical procedure with patellar resurfacing
Detailed description
The medial unicompartmental prosthesis procedure associated with patellofemoral is reserved for active patients suffering from bicompartmental gonarthrosis in which total knee replacement is to be avoided. The advantage for the patient, compared to total prosthesis surgery, consists in the less invasive nature of the surgical gesture, in the total preservation of the cruciate ligaments and the external compartment and therefore of the native joint biomechanics with the possibility of remote revision with total prosthesis from first implant.
Patients keep "their knee" which is coated and not replaced with advantages in terms of joint feedback and functionality in daily activities and sports practices. This study aims to compare two groups of patients suffering from bicompartmental gonarthrosis (medial and patellofemoral gonarthrosis): Group A undergoing a bicompartmental prosthesis surgical procedure; Group B undergoing a total denture surgical procedure with patellar resurfacing. The two groups will be evaluated with clinical and functional scores aimed at evaluating the outcome in the two surgical procedures.
The number and type of exams are as follows:
- Randomization to Group A or Group B (ad hoc)
- Knee replacement surgery (as usual)
- Compilation of KSS questionnaire at 1, 2, 6, 12 months of follow-up with clinical and functional scores (as a matter of practice)
- Questionnaires and scales (WOMAC, Tegner, VAS and patient satisfaction) at 2, 6, 12 months post intervention (as a matter of practice)
- Recording of any adverse events at 1, 2, 6, 12 months after surgery (as a matter of practice)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial denture surgical procedure | Experimental | Procedure: Prosthetic Surgical Procedure |
| Total denture surgical procedure with patellar resurfacing | Active comparator | Procedure: Prosthetic Surgical Procedure |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Grade 3-4 sec Kellgren-Lawrence medial gonarthrosis
- Patellar symptoms
- Primary gonarthrosis
- Patients with ligament integrity
- Age between 40 and 85 years inclusive
Key exclusion criteria (9 listed)
- Cognitive impairment
- Psychiatric disorders
- Neuromuscular disorders
- Age > 85 years and <40 years
- Lateral gonarthrosis grade 4 sec Kellgren-Lawrence
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 |
|---|---|---|
| Prosthetic Surgical ProcedureThe population consists of 48 patients divided into two groups: 24 patients Group A experimental group: partial denture surgical procedure 24 patients Group B control group: total denture surgical procedure with patellar resurfacing | Procedure or surgery | Partial denture surgical procedure, Total denture surgical procedure with patellar resurfacing |
Primary outcome
Assess the difference in score of the KSS (Knee Society Score) questionnaire, completed by the patient in group A compared to the patient in group B
Time frame: 1 month after surgery
Evaluate the difference in score of the KSS questionnaire, at 1 month after surgery, completed by the patient of group A compared to the patient of group B
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prosthetic Surgical Procedure in people with Knee Disease, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 12 Mar 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Cittera (0283502224, elena.cittera@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the difference in score of the KSS (Knee Society Score) questionnaire, completed by the patient in group A compared to the patient in group B (time frame: 1 month after surgery). 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 12 Mar 2024.