French Version of the Banff Patellar Instability Instrument 2.0

NCT06932900 | Active Not Recruiting

• 1 other identifier: 2022-4329
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patellar Instability

Outcome Measures

Primary Outcomes (3)

• Questionnaire Banff Patellar Instability 2.0 Index in French

  Questionnaire. (0-100 (0 = Worst, 100 = Best))

  Baseline, 1 week and 6 month post intervention

• Questionnaire Anterior Knee Pain Scale (Kujala)

  Questionnaire. (0-100 (0 = Worst, 100 = Best))

  Baseline and 6 month post intervention

• Socio-Demographic

  Age, Sex, Time since symptoms, Scolarship, Nationality

  Baseline

Study Arms (1)

validation

person with patellar instability that will respond to the questionnaires

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients consulting at the CHUS in Sherbrooke or at the Schriners Hospital in Montreal for patellar instability

You may qualify if:

• patient diagnosed with patellar instability with conservative or surgical treatment
• fluent in both spoken and written French

You may not qualify if:

• 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 answering fewer than 19 questions (out of 23 questions)

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

CIUSSS de l'Estrie-CHUS, 3001, 12e Ave Nord

Sherbrooke, Quebec, J1H5N4, Canada

Location

Study Officials

• François Vézina, Doctor

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: orthopaedic surgeon

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 17, 2025
• Study Start: November 15, 2021
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

CA (1)