Clinical trial NCT02355301: Improve the Quality of Care in Patients With Orthopaedic Disorders
Official title: How to Improve the Quality of Care in Patients With Orthopaedic Disorders? - by Using the ICF in All Patients After Conservative or Surgical Treatment. - Through the Creation of an International Norm to Improve the Surgical Precision
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Orthopedic Disorder
Keywords: ICF, impairment, activity, satisfaction, quality of care
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Orthopeadic team in Saint-luc Hospital Brussels
name: Université Catholique de Louvain
name: Institute of Mechanics, Materials and Civil Engineering UCL
First posted: 2015-02-04
Enrollment: 2000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with orthopedic disorders usually followed in the Department of Orthopedics clinics (St Luc Hospital - Brussels - Belgium)

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.

Detailed description: The investigators will recruit patients with orthopedic disorders on voluntary basis through department in St Luc Hospital in Brussels, old of 0 to 90 years, men and women with muscular-skeletal impairments (arthrosis, bone or muscle injury, ....). The investigators will exclude patients with multiple pathologies or not able to understand the instructions. They thus impropre the effectiveness of the treatment in Orthopaedics by better defining the route of most effective surgical first for the patient in arthroplasty (mini invasive, posterior, anterior), the most appropriate knee prosthesis type (design of prothesis), the conservative treatment properly to improve the quality of life of patients with orthopedic disorders (plaster, brace, physiotherapy...). They will evaluate the impact of 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...) following the ICF-WHO model.

In addition, they will dispose of data necessary to better define the surgical precision (international organization for standardization ISO Norm), the quality of surgical care by analyzing data collected by high-precision tools at the surgical treatments.

Patients will be subject to different clinical assessments, fill out questionnaires or come to the laboratory for analysis of the movement depending on the goal defined for each patient. Patients will have their current clinical follow-up (RX, scanner, mobility, force measurement, stiffness...) which the investigators be able to join a quantified analysis of the movement in the laboratory, satisfaction questionnaires, questionnaires measuring the impact of treatment on quality of life and their restriction of activities. It is a broad-spectrum study to try to improve the quality of care within a service target of orthopedics.

Eligibility criteria: Inclusion Criteria:

* all patients with orthopedic disorders : muscular skeletal impairment

Exclusion Criteria:

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

Primary outcomes:
measure: activities
timeFrame: 6 months
Secondary outcomes:
measure: Impairment: ICF domain
timeFrame: 6 months
measure: participation: ICF domain
timeFrame: 6 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires St Luc Brussels
Study officials:
affiliation: Cliniques universitaires St Luc Brussels
name: Olivier Cornu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.