NCT05441332

Brief Summary

The purpose of this study is to describe and compare the kinematic deficiencies specifically associated with each of the 3 main clinical phenotypes of patellofemoral pain syndrome. The prevalence of patellofemoral pain is high with a high rate of chronicity and recurrence and an overrepresentation of young, athletic and female populations. There are multiple classifications of patellofemoral pain syndrome. A pragmatic classification distinguishes 3 main clinical phenotypes of patellofemoral pain syndrome: with objectively displaceable patella, with extra-patellar alignment problems and without alignment problems. The pathophysiology of patellofemoral pain syndrome is multifactorial involving static and dynamic dysfunctions of the hip, knee and foot, which remain incompletely elucidated to date. The links between the clinical and biomechanical aspects are still unclear and the kinematic and neuromuscular deficiencies associated with the 3 main clinical phenotypes are poorly understood. A validated non-invasive device allows the 3D evaluation of femorotibial rotations during walking.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 14, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 1, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

December 9, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2025

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

June 14, 2022

Last Update Submit

September 8, 2025

Conditions

Keywords

Patellofemoral pain syndrome3D Kinematicsassessmentclinical phenotypesdynamic deficiencies

Outcome Measures

Primary Outcomes (1)

  • Amplitude of rotation

    Amplitude of rotation of the femur with respect to the tibia in the bearing phase in the 3 planes of space

    Day of inclusion (up to 10 days)

Secondary Outcomes (23)

  • Length measures

    Day of inclusion (up to 10 days)

  • Q angle (in degree)

    Day of inclusion (up to 10 days)

  • Varus valgus(in degree)

    Day of inclusion (up to 10 days)

  • Peak torque (N.m)

    Day of inclusion (up to 10 days)

  • Total work (N.m)

    Day of inclusion (up to 10 days)

  • +18 more secondary outcomes

Study Arms (1)

Patellofemoral pain syndrome

EXPERIMENTAL

Kinematic and neuromuscular assessment

Other: EOS RadiationBehavioral: Semi-structured interview

Interventions

One EOS exam of lower extremities

Also known as: EOS X-ray exams
Patellofemoral pain syndrome

Semi-structured interview to identify factors influencing patient adherence behavior for a sub-group of 15 patients. By phone, between 1 to 3 months after inclusion.

Patellofemoral pain syndrome

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical diagnosis of SDFP :
  • Anterior pain of the knee, mechanical, in front of and around the patella noted at more than 3/10 on a simple numerical scale (ligament or meniscal damage, synovial plicae, tendinopathies, apophysitis, neuromas, and osteoarthritis FT are differential diagnoses),
  • Pain during any of the following activities: Going up / down stairs, squats, jumps, jogging, sitting, crouching.
  • Duration of knee anterior pain greater than 1 month
  • Affiliation to a social insurance
  • Signature of the consent to participate

You may not qualify if:

  • Neurological disorders affecting the lower extremities
  • Radiographic FT osteoarthritis
  • History of surgery or trauma to the lower limb less than 1 year old
  • Intra-articular knee infiltration ≤ 2 months
  • Cognitive or behavioral problems making it impossible to assess
  • Unable to speak, read and write French
  • Patients under guardianship or curatorship,
  • Patients receiving AME (French State Medical aid)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis - Hôpital Cochin

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Marvin COLEMAN, MSc, PhD student

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2022

First Posted

July 1, 2022

Study Start

December 9, 2022

Primary Completion

September 27, 2024

Study Completion

February 27, 2025

Last Updated

September 15, 2025

Record last verified: 2025-09

Locations