Improve the Quality of Care in Patients With Orthopaedic Disorders

Orthopedic Disorder Clinical Trial

— QualOrtho  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02355301
• Other study ID #: CD26012015
• Status: Recruiting
• Start date: April 5, 2015
• Est. completion date: October 2026

Study information

• Verified date: December 2023
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Christine DJ Detrembleur, PhD
• Phone: 003227645365
• Email: christine.detrembleur[@]uclouvain.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: October 2026
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 90 Years

Eligibility

Inclusion Criteria:

• all patients with orthopedic disorders : muscular skeletal impairment

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

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

Locations

Country	Name	City	State
Belgium	Cliniques universitaires St Luc Brussels	Brussels

Sponsors (4)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Institute of Mechanics, Materials and Civil Engineering UCL, Orthopeadic team in Saint-luc Hospital Brussels, Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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/ — View 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.108.54 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	activities	improve the gait; improve the daily activities (washing, eating, dressing...)	6 months
Secondary	Impairment: ICF domain	force, stiffness, mobility, dexterity	6 months
Secondary	participation: ICF domain	effect of treatment on Sports, work, cultural and associative life	6 months