NCT06257862

Brief Summary

The Anterior Knee Pain Scale (Kujala) is a questionnaire designed to assess adults with patellofemoral disorders and is widely used in both anterior knee pain and patellar dislocation patients.The questionnaire is a patient-reported outcome measure (PROM), that was developed in 1993 and has been translated and validated into most major languages (e.g. French, Italian, Chinese, German, and Spanish) and has gained wide international acceptance. In a recent systematic review, the Kujala was among the eight most commonly used PROMS for patients with patellofemoral pain. In addition, the Kujala was used in almost 80% of studies of patellofemoral instability/dislocation. The Kujala has been widely used in Denmark during the last 15 years, but surprisingly it has not been translated and validated in Danish according to international guidelines. The translation of the Kujala into Danish will stimulate to more valid and precise results of the Kujala questionnaire in both patients with anterior knee pain and patients with patellar dislocation The aim of this study is to cross-cultural translate and adapt the Kujala into a Danish Kujala-DK. Secondarily to determine validity and reliability of the Kujala-DK in two consecutive Danish populations of patients with either anterior knee pain or patellar dislocation.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Mar 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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 Progress57%
Mar 2024Dec 2027

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
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

2.8 years

First QC Date

February 6, 2024

Last Update Submit

September 30, 2025

Conditions

Keywords

MPFLKUJALAPAINQuestionnaireTRANSLATION

Outcome Measures

Primary Outcomes (4)

  • Kujala (Anterior Knee Pain Scale)

    Patient reported outcome score. (0-100 (0 = Worst, 100 = Best)

    Baseline, after 6-8 days

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

    Patient reported outcome score. (0-100 (0 = Worst, 100 = Best)

    Baseline

  • International knee documentation committee (IKDC)

    Patient reported outcome score. (0-100 (0 = Worst, 100 = Best)

    Baseline

  • Banff patella instability instrument (BPII 2.0)

    Patient reported outcome score. (0-100 (0 = Worst, 100 = Best)

    Baseline

Eligibility Criteria

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

MPFL-reconstructed patients.

You may qualify if:

  • Danish speaking
  • MPFL-reconstructed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Sports Trauma, Palle Juul-Jensens Boulevard 99

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Patellofemoral Pain SyndromePain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

October 1, 2025

Record last verified: 2025-09

Locations