Knee DiseasePUCILNCT05749965
Results of Unicompartmental Knee Arthroplasties in Patients Beyond Historical Indications (PUCIL)
An observational study of Knee Disease, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Primary objective: To compare medial uni compartimental knee arthroplasty between patients who had a limit factor prior to the surgery ans patients who fill thé historical criteria. Secondary objectives 1 to compare survival of medial UKA between patients with one limit factor and those with multiple limits. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Disease
- What is being tested?
- Unicompartmental knee arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 522 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2023to Mar 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All medial UKA implanted between 2009 and 2015 at the CCEG with follow up at 7 years
Who may be able to join
- medial UKA implanted between 2009 and 2015 at the CCEG
Who cannot join
- no other UKA
- lost to follow up
- patient refuses
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Chirurgical Emile Gallé
Nancy, 54000
Grégoire Vaz, 0649852557, gregoire.vaz@gmail.com
Andre Fernandez, 0650506979, a.fernandez@chru-nancy.fr
About this study
Official title: Unicompartimental Knee Arthroplasties When Borders Are Crossed : Survival Study at 7 Years
Primary objective:
To compare medial uni compartimental knee arthroplasty between patients who had a limit factor prior to the surgery ans patients who fill thé historical criteria.
Secondary objectives
1 to compare survival of medial UKA between patients with one limit factor and those with multiple limits.
- To identify the prognosis factors of failure in medial UKA in our center during the time of our analysis (2009-2015)
Read the detailed description
7 year follow up survival if no amputation or no removal of UKA for TKA
- Conditions
- Knee Disease
- Being tested
- Unicompartmental knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unicompartmental knee arthroplastyProcedure or surgery
medial unicompartmental knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Limit indications | Obèse (BMI>30), ACL déficiency, HKA > 10°, flessum >10° [HKA : hop knee angle] Receives: Procedure: Unicompartmental knee arthroplasty | |
| Historical indications | Patient with a BMI between 18,5 and 30, HKA <10°, functionnal ACL, no flessum or <5° Receives: Procedure: Unicompartmental knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of medial UKA
UKA changed or replaced by TKA
Measured: 7 years
Secondary outcomes (2)
to compare UKA survival if multiple limit indication
UKA changed or replaced by TKA
Measured: 7 years
to identify prognostic factors of re operation of patients with a medial UKA implanted between 2009 and 2015 at the CCEG
ACL, flessum, HKA, weight
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (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 Central Hospital, Nancy, FranceThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 522 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FERNANDEZ Andrea, Central Hospital, Nancy, France
- Investigators
- Andre Fernandez, Study director, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749965
- Sponsor's protocol ID
- 2022PI091
- Acronym
- PUCIL
- Status last verified
- Mar 2023
- First submitted
- 8 Feb 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unicompartimental Knee Arthroplasties When Borders Are Crossed : Survival Study at 7 Years
- ClinicalTrials.gov ID
- NCT05749965
- Acronym / sponsor ID
- PUCIL / 2022PI091
- Conditions
- Knee Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 522 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 1 Mar 2023 (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.
Primary objective:
To compare medial uni compartimental knee arthroplasty between patients who had a limit factor prior to the surgery ans patients who fill thé historical criteria.
Secondary objectives
1 to compare survival of medial UKA between patients with one limit factor and those with multiple limits.
- To identify the prognosis factors of failure in medial UKA in our center during the time of our analysis (2009-2015)
Detailed description
7 year follow up survival if no amputation or no removal of UKA for TKA
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Limit indications | – | Procedure: Unicompartmental knee arthroplastyObèse (BMI>30), ACL déficiency, HKA > 10°, flessum >10° [HKA : hop knee angle] |
| Historical indications | – | Procedure: Unicompartmental knee arthroplastyPatient with a BMI between 18,5 and 30, HKA <10°, functionnal ACL, no flessum or <5° |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All medial UKA implanted between 2009 and 2015 at the CCEG with follow up at 7 years
Key inclusion criteria (1 listed)
- medial UKA implanted between 2009 and 2015 at the CCEG
Key exclusion criteria (3 listed)
- no other UKA
- lost to follow up
- patient refuses
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 |
|---|---|---|
| Unicompartmental knee arthroplastymedial unicompartmental knee arthroplasty | Procedure or surgery | Historical indications, Limit indications |
Primary outcome
Survival of medial UKA
Time frame: 7 years
UKA changed or replaced by TKA
2 secondary outcomes
to compare UKA survival if multiple limit indication
Time frame: 7 years
to identify prognostic factors of re operation of patients with a medial UKA implanted between 2009 and 2015 at the CCEG
Time frame: 7 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Knee Disease
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
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.
Andre Fernandez study director
Central Hospital, Nancy, France
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 Knee Disease, run by Central Hospital, Nancy, France at 1 site in France.
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 1 inclusion and 3 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 2 Mar 2023. 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 France. 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 Grégoire Vaz (0649852557, gregoire.vaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of medial UKA (time frame: 7 years). 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 2 Mar 2023.