NCT06257849

Brief Summary

The Banff Patella Instability Instrument (BPII 2.0) is a disease-specific quality of life questionnaire designed to assess adults with patellar dislocations. As the BPII 2.0 already is cross-cultural translate and adapted to Danish the examination of the the psychometric properties of the Danish version is still needed The aim om this study is to determine validity and reliability of the Danish version BPII 2.0-DK in a Danish populations of patients with patellar dislocation.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Mar 2024Dec 2026

First Submitted

Initial submission to the registry

February 6, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

2.6 years

First QC Date

February 6, 2024

Last Update Submit

September 30, 2025

Conditions

Patella Dysplasia

Keywords

BPII 2.0Patella instabilityKneeQuestionnaire

Outcome Measures

Primary Outcomes (4)

  • Banff patella instability instrument (BPII 2.0)

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

    Baseline, after 6-8 days

  • Anterior knee pain scale (Kujala)

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

    Baseline

  • Victorian Institute of Sports Assessment - Patella questionnaire (VISA-P)

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

    Baseline

  • International knee documentation committee (IKDC)

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

    Baseline

Interventions

BPII 2.0OTHER

Banff Patella Instability Instrument 2.0 is a questionnaire developed for measuring outcome in patients with patella instability

Also known as: Banff Patella Instability Instrument 2.0

Eligibility Criteria

Age14 Years - 40 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with Patella instability

You may qualify if:

  • Danish Speaking
  • Patella instability problems

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Division of Sports Trauma, Palle Juul-Jensens Boulevard 99

Aarhus N, 8200, Denmark

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD, MD

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 14, 2024

Study Start

March 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 1, 2025

Record last verified: 2025-09

Locations

DK(2)