Active — Not RecruitingNot Applicable

French Version of the Banff Patellar Instability Instrument 2.0

Canada52 participantsStarted 2021-11-15

Plain-language summary

There are several treatment options for patellofemoral instability, but no established guidelines currently exist. An important step toward developing a consensus is to examine the influence of each intervention through the collection of both subjective and objective outcomes. Most outcome measures commonly used for knee pathologies are primarily designed to monitor degenerative conditions (e.g., osteoarthritis) or ligamentous instability (e.g., anterior cruciate ligament rupture). Very few questionnaires are specific to patellar instability, a condition characterized by distinct signs and symptoms compared to other knee disorders. The Banff Patellar Instability Instrument (BPII) was developed with this gap in mind, in accordance with the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) criteria. This condition-specific tool is designed to subjectively assess the functional impact of patellofemoral instability on patients' quality of life, which is the most important factor in evaluating treatment success. Currently, there is no validated French-language outcome measure specific to patellofemoral instability. To improve patient care, the availability of such a validated tool in French is essential, both for clinical use and for conducting future research. To address this issue, the primary objective of this study is to translate the Banff Patellar Instability Instrument 2.0 (BPII 2.0) into French, following the three-step process described in the IQOLA project and in accordance with the guidelines outlined by the American Academy of Orthopaedic Surgeons (AAOS), and to evaluate its validity in a French-speaking population. Research Question Is the French version of the BPII 2.0 a valid tool to assess function in French-speaking patients diagnosed with patellofemoral instability? Specific Objectives To translate the Banff Patellar Instability Instrument 2.0 into French using a dual forward-backward translation process. To evaluate the psychometric properties of the French version of the BPII 2.0, including its reliability and validity.

Who can participate

Age range

14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * patient diagnosed with patellar instability with conservative or surgical treatment * fluent in both spoken and written French Exclusion Criteria: * Patients who are unable to understand and/or respond to the questionnaire * Patients with another diagnosis or knee pathology under study (e.g., complex ligament tear of the knee, gonarthrosis) * Patients with another diagnosis or lower limb pathology under study with secondary functional impairment (e.g., coxarthrosis) * Patients with a change in the condition of the lower limb under study a. Exclusion from test-retest reliability calculations if symptoms of patellofemoral instability worsen or if there is new involvement of this lower limb between T0 and T1 b. Exclusion from response to change calculations if new involvement of the lower limb (e.g., ipsilateral lower limb trauma) occurs after treatment, i.e., between T0 and T2 * Patients answering fewer than 19 questions (out of 23 questions)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Questionnaire Banff Patellar Instability 2.0 Index in French

Timeframe: Baseline, 1 week and 6 month post intervention

Questionnaire Anterior Knee Pain Scale (Kujala)

Timeframe: Baseline and 6 month post intervention

Socio-Demographic

Timeframe: Baseline

Trial details

NCT IDNCT06932900

SponsorUniversité de Sherbrooke

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-08

View on ClinicalTrials.gov More Patellar Instability trials