Orthopedic DisorderQualOrthoNCT02355301
Improve the Quality of Care in Patients With Orthopaedic Disorders
An observational study of Orthopedic Disorder, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 1 year to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- orthopedic
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Apr 2015to 1 Oct 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with orthopedic disorders usually followed in the Department of Orthopedics clinics (St Luc Hospital - Brussels - Belgium)
Who may be able to join
- all patients with orthopedic disorders : muscular skeletal impairment
Who cannot join
- Dementia patients with multiple disorders Patients who do not understand the instructions
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires St Luc Brussels
Brussels, 1200
Detrembleur DJ Christine, PhD, 003227645365, christine.detrembleur@uclouvain.be
Philippe Mahaudens, PhD, 003227645375, philippe.mahaudens@uclouvain.be
About this study
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
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.
Read the 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.
- Conditions
- Orthopedic Disorder
- Being tested
- orthopedic
- Keywords
- ICF, impairment, activity, satisfaction, quality of care
- Medical subject headings
- Musculoskeletal Diseases, Motor Activity, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthopedicProcedure or surgery
Compare the type of treatment chosen by the orthopedist with a functional assessment (ICF-WHO model)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: orthopedic |
What is being measured
The primary outcome is the main question the study is designed to answer.
activities
improve the gait; improve the daily activities (washing, eating, dressing...)
Measured: 6 months
Secondary outcomes (2)
Impairment: ICF domain
force, stiffness, mobility, dexterity
Measured: 6 months
participation: ICF domain
effect of treatment on Sports, work, cultural and associative life
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study start5 Apr 2015
- Primary completionDec 2025 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopeadic team in Saint-luc Hospital Brussels, Université Catholique de Louvain, Institute of Mechanics, Materials and Civil Engineering UCL
- Responsible party
- Principal investigator, Detrembleur, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Investigators
- Olivier Cornu, MD,PhD, Principal investigator, Cliniques universitaires St Luc Brussels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355301
- Sponsor's protocol ID
- CD26012015
- Acronym
- QualOrtho
- Status last verified
- Jun 2024
- First submitted
- 30 Jan 2015
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 19407231Bollens 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.
PubMed 23757297Knaepen C, Otlet V, Detrembleur C, Docquier PL, Stoquart G. Impact of single-event multilevel surgery on gait in children with cerebral palsy: A retrospective study. Gait Posture. 2026 Oct;130:110255. doi: 10.1016/j.gaitpost.2026.110255. Epub 2026 Jun 9.
PubMed 42447634Hage G, Buisseret F, Brismee JM, Dierick F, Detrembleur C, Hage R. Evaluating the additive diagnostic value of DidRen LaserTest: Correlating temporal and kinematic predictors and patient-reported outcome measures in acute-subacute non-specific neck pain. J Bodyw Mov Ther. 2024 Jul;39:201-208. doi: 10.1016/j.jbmt.2024.03.004. Epub 2024 Mar 7. No abstract available.
PubMed 38876626
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02355301
- Acronym / sponsor ID
- QualOrtho / CD26012015
- Conditions
- Orthopedic Disorder
- Keywords
- ICF, impairment, activity, satisfaction, quality of care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Orthopeadic team in Saint-luc Hospital Brussels, Université Catholique de Louvain, Institute of Mechanics, Materials and Civil Engineering UCL
- Study start
- 5 Apr 2015 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 4 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with orthopedic disorders | – | Procedure: orthopedicPatients 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. |
Who may qualify
- Ages
- 1 year to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with orthopedic disorders usually followed in the Department of Orthopedics clinics (St Luc Hospital - Brussels - Belgium)
Key inclusion criteria (1 listed)
- all patients with orthopedic disorders : muscular skeletal impairment
Key exclusion criteria (1 listed)
- Dementia patients with multiple disorders Patients who do not understand the instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| orthopedicCompare the type of treatment chosen by the orthopedist with a functional assessment (ICF-WHO model) | Procedure or surgery | patients with orthopedic disorders |
Primary outcome
activities
Time frame: 6 months
improve the gait; improve the daily activities (washing, eating, dressing...)
2 secondary outcomes
Impairment: ICF domain
Time frame: 6 months
participation: ICF domain
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Results publication: PubMed 19407231Caty 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.
- Results publication: PubMed 23757297Bollens 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.
- Derived from this study: PubMed 42447634Knaepen C, Otlet V, Detrembleur C, Docquier PL, Stoquart G. Impact of single-event multilevel surgery on gait in children with cerebral palsy: A retrospective study. Gait Posture. 2026 Oct;130:110255. doi: 10.1016/j.gaitpost.2026.110255. Epub 2026 Jun 9.
- Derived from this study: PubMed 38876626Hage G, Buisseret F, Brismee JM, Dierick F, Detrembleur C, Hage R. Evaluating the additive diagnostic value of DidRen LaserTest: Correlating temporal and kinematic predictors and patient-reported outcome measures in acute-subacute non-specific neck pain. J Bodyw Mov Ther. 2024 Jul;39:201-208. doi: 10.1016/j.jbmt.2024.03.004. Epub 2024 Mar 7. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Cornu, MD,PhD principal investigator
Cliniques universitaires St Luc Brussels
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Disorder, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine DJ Detrembleur, PhD (003227645365, christine.detrembleur@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
activities (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02355301, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.