NCT02250144

Brief Summary

Patellofemoral pain syndrome is one of the most common musculoskeletal disorders. It is defined as an anterior knee pain. Its origin is a conflict during patellar tracking, due to patellofemoral malalignment and soft tissue overload. A few recent studies seem to show a benefit of prefabricated feet orthoses in patellofemoral pain syndrome, alone or in association with rehabilitation. However, no one has analyzed the outcome of morpho-specific foot orthoses in a prospective randomized study. The purpose of this prospective randomized study is to compare clinical outcomes in daily living and in sports activities, between morpho-specific and placebo foot orthoses. Morpho-specific foot orthoses are designed according to the patient's morphotype. They are intended to correct structural defects of the hindfoot, midfoot and forefoot, in the aim to correct abnormal overload during patellofemoral tracking.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

3 active sites

Status
unknown

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

September 16, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 7, 2015

Status Verified

August 1, 2015

Enrollment Period

1.2 years

First QC Date

September 16, 2014

Last Update Submit

August 6, 2015

Conditions

Patellofemoral Pain Syndrome

Keywords

Patellofemoral pain syndromeFeet orthosesKOOS

Outcome Measures

Primary Outcomes (1)

  • Item Pain of the KOOS Score

    Twice : at inclusion and at 10 weeks follow-up with feet orthoses

Secondary Outcomes (3)

  • KOOS Score (items Symptoms, Activities of daily living, Sport and recreation function, Knee-related quality of life)

    Twice : at inclusion and at 10 weeks follow-up with feet orthoses

  • Kujala Score

    Twice : at inclusion and at 10 weeks follow-up with feet orthoses

  • Pain level

    Twice : at inclusion and at 10 weeks follow-up with feet orthoses

Study Arms (2)

Morpho-specific foot orthoses

EXPERIMENTAL

Morpho-specific thermo-molded foot orthoses are designed according to the patient's morphotype. Orthoses are custom-molded from different materials such as BIOFLUX resin, Covercuir MF, EVA300/60, EVA400/70, PE255/55, ABSORB Dur and CAPITON PU.

Device: Foot orthoses

Placebo foot orthoses

PLACEBO COMPARATOR

The placebo foot orthoses will be made with the same principle of molding and with the same materials as for the experimental group. The only difference is that they involve no active corrective insert element : they will be made without morphotype correction.

Device: Foot orthoses

Interventions

Foot orthosesDEVICE
Morpho-specific foot orthosesPlacebo foot orthoses

Eligibility Criteria

Age12 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male or female aged 12-40 years
  • Patellofemoral pain syndrome
  • Patient affiliated to a social protection regime
  • Patient who signed an informed consent
  • For teenagers with no complete growth and muscular maturation, failure of appropriate rehabilitation during minimum 2 months
  • Patient informed of the results of the prior medical examination
  • Normality (no sign of osteoarthritis) of the knee radiographs
  • Ability to read and understand French

You may not qualify if:

  • Knee osteoarthritis
  • Systemic disease
  • Inflammatory rheumatism disease
  • Unstable knee
  • Prior patellofemoral dislocation
  • Osteochondrosis
  • Referred pain from a hip or spine disease (particularly proximal femoral epiphysiolysis in the teenagers)
  • A history of patellar trauma
  • A history of knee surgery
  • Meniscus, ligament or osteochondral pathology
  • Knee tendinitis or bursitis
  • Neurologic disease
  • Pregnancy
  • Antidepressant therapy or behavioral disorder
  • Patient unable to comply the required maximum observance
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cabinet libéral - 12, rue du Puits

Haguenau, 67500, France

RECRUITING

Service de Chirurgie Orthopédique - Hôpital CCOM - Hôpitaux Universitaires de Strasbourg

Illkirch-Graffenstaden, 67400, France

RECRUITING

Cabinet libéral - 50, avenue des Vosges

Strasbourg, 67000, France

RECRUITING

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Central Study Contacts

Yann DIESINGER, MD

CONTACT

388552310yann.diesinger@chru-strasbourg.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 26, 2014

Study Start

June 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 7, 2015

Record last verified: 2015-08

Locations

FR(3)