NCT02355301

Brief Summary

The main objective of the investigators is to improve the quality of care in patients with orthopedic disorders followed in St Luc hospital (Brussels Belgium). To do this, the investigators want to assess the impact of Orthopedic treatments at the structural level (bone structure, muscle, etc.), at the functional level (mobility, strength, stiffness...), on the restriction of activities of patients (walking, make its care daily..) and on the limitation of participation in the life of every day (sport, work, social life, cultural...). This functional evaluation of patients with orthopedic disorders by the ICF model is an original approach rarely used in muscular-skeletal impairments that can very improve the management of these patients and their quality of life. In addition, the investigators associate the harvesting of all medical and computer data collected by high-precision tools in the surgical treatments, to better define the surgical precision and improve the quality of surgical care.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress97%
Apr 2015Oct 2026

First Submitted

Initial submission to the registry

January 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

April 5, 2015

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

10.7 years

First QC Date

January 30, 2015

Last Update Submit

June 26, 2024

Conditions

Orthopedic Disorder

Keywords

ICF, impairment, activity, satisfaction, quality of care

Outcome Measures

Primary Outcomes (1)

  • activities

    improve the gait; improve the daily activities (washing, eating, dressing...)

    6 months

Secondary Outcomes (2)

  • Impairment: ICF domain

    6 months

  • participation: ICF domain

    6 months

Study Arms (1)

patients with orthopedic disorders

Patients with muscular skeletal impairments receiving a treatment (A, B, C...). The investigators compare these treatments (A, B, C...) in function of ICF model in order to improve the quality of care in orthopedic department.

Procedure: orthopedic

Interventions

orthopedicPROCEDURE

Compare the type of treatment chosen by the orthopedist with a functional assessment (ICF-WHO model)

patients with orthopedic disorders

Eligibility Criteria

Age1 Year - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with orthopedic disorders usually followed in the Department of Orthopedics clinics (St Luc Hospital - Brussels - Belgium)

You may qualify if:

  • all patients with orthopedic disorders : muscular skeletal impairment

You may not qualify if:

  • Dementia patients with multiple disorders Patients who do not understand the instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires St Luc Brussels

Brussels, 1200, Belgium

RECRUITING

Related Publications (2)

  • Caty GD, Detrembleur C, Bleyenheuft C, Deltombe T, Lejeune TM. Effect of upper limb botulinum toxin injections on impairment, activity, participation, and quality of life among stroke patients. Stroke. 2009 Jul;40(7):2589-91. doi: 10.1161/STROKEAHA.108.544346. Epub 2009 Apr 30.

    PMID: 19407231RESULT

  • Bollens B, Gustin T, Stoquart G, Detrembleur C, Lejeune T, Deltombe T. A randomized controlled trial of selective neurotomy versus botulinum toxin for spastic equinovarus foot after stroke. Neurorehabil Neural Repair. 2013 Oct;27(8):695-703. doi: 10.1177/1545968313491002. Epub 2013 Jun 10.

    PMID: 23757297RESULT

MeSH Terms

Conditions

Musculoskeletal DiseasesMotor ActivityPersonal Satisfaction

Interventions

Orthopedic Procedures

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

TherapeuticsSurgical Procedures, Operative

Study Officials

  • Olivier Cornu, MD,PhD

    Cliniques universitaires St Luc Brussels

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine DJ Detrembleur, PhD

CONTACT

003227645365christine.detrembleur@uclouvain.be

Philippe Mahaudens, PhD

CONTACT

003227645375philippe.mahaudens@uclouvain.be

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 30, 2015

First Posted

February 4, 2015

Study Start

April 5, 2015

Primary Completion

December 1, 2025

Study Completion (Estimated)

October 1, 2026

Last Updated

June 27, 2024

Record last verified: 2024-06

Locations

BE(1)