Improve the Quality of Care in Patients With Orthopaedic Disorders (QualOrtho)

December 12, 2023 updated by: Detrembleur, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • all patients with orthopedic disorders : muscular skeletal impairment

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Compare the type of treatment chosen by the orthopedist with a functional assessment (ICF-WHO model)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
activities
Time Frame: 6 months
improve the gait; improve the daily activities (washing, eating, dressing...)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impairment: ICF domain
Time Frame: 6 months
force, stiffness, mobility, dexterity
6 months
participation: ICF domain
Time Frame: 6 months
effect of treatment on Sports, work, cultural and associative life
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Collaborators

Université Catholique de Louvain
Orthopeadic team in Saint-luc Hospital Brussels
Institute of Mechanics, Materials and Civil Engineering UCL

Investigators

  • Principal Investigator: Olivier Cornu, MD,PhD, Cliniques universitaires St Luc Brussels

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2015

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

January 30, 2015

First Submitted That Met QC Criteria

January 30, 2015

First Posted (Estimated)

February 4, 2015

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD26012015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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