ECHOSTEOM: Evaluation of the Contribution of Musculoskeletal Ultrasound to the General Practitioner's Overall Decision-making Strategy

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06068595
Collaborator
University of Lorraine (Other)
300
1
1
42
7.1

Study Details

Study Description

Brief Summary

The hypothesis of this study is that musculoskeletal point of care ultrasonography would support the GP's decision and ultimately improve patient management.

The aim of this study is to evaluate, in the context of suspected musculoskeletal abnormality, the contribution of musculoskeletal point of care ultrasonography to the general practitioner's overall decision-making strategy, defined according to the following 5 axes: diagnosis (I), therapy (II), patient orientation (III), prescription of complementary examinations (IV) and follow-up (V).

Condition or Disease Intervention/Treatment Phase
  • Other: musculoskeletal ultrasound
N/A

Detailed Description

The study circuit takes place in a single visit.

  1. The investigating physician suspects a musculoskeletal anomaly following an initial clinical examination.

  2. The patient (who meets the inclusion criteria and has no non-inclusion criteria) gives consent to participate, after receiving information about the study.

  3. The investigator fills in the e-CRF (appendix III), clinical examination, medical interrogation and his or her decisions according to the 5 axes, which cannot be modified, as the structure of the e-CRF planned in advance does not allow backtracking. The investigator performs the targeted musculoskeletal ultrasound with his or her personal ultrasound machine, following his or her usual operating procedure.

  4. The investigator fills in the e-CRF with the results of the targeted ultrasound scan and indicates any modifications to the decision axes.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
The Contribution of Targeted Musculoskeletal Ultrasound to the General Practitioner's Overall Decision-making Strategy for Patients With Suspected Musculoskeletal Pathology: a Before/After Study
Anticipated Study Start Date :
Apr 1, 2024
Anticipated Primary Completion Date :
Apr 1, 2027
Anticipated Study Completion Date :
Oct 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Other: Patients

Patient with musculoskeletal anomalies

Other: musculoskeletal ultrasound
After clinical examination and medical interrogation, The investigating physician gives her decisions in the e-CRF according to the 5 axes: diagnosis (I), therapy (II), patient referral (III), prescription of additional tests (IV) and follow-up (V). The investigator performs the targeted musculoskeletal ultrasound with his personal ultrasound machine, following his usual operating procedure and give/keep the final diagnostic.

Outcome Measures

Primary Outcome Measures

  1. Percentage of patients [3 years]

    Percentage of patients for whom the musculoskeletal point of care ultrasonography led to a change in the GP's overall decision-making strategy (binary yes/no variable) of patients for whom led to a change in the GP's overall decision-making strategy (binary yes/no variable)

Secondary Outcome Measures

  1. Frequency of the anatomical sites [3 years]

    Frequency of the different anatomical sites (shoulder, elbow, arm, etc.) and structures (osteoarticular pathologies, tendon and retinacular pathologies, etc.) concerned

  2. Frequency of modifications [3 years]

    Frequency of different modifications for each axis and within each axis

  3. Frequency of diagnoses of post-CTA confirmation [3 years]

    List and frequency of diagnoses in the case of post-CTA confirmation

  4. Frequency of diagnoses of post-CTA modifications [3 years]

    List and frequency of diagnoses in the case of post-CTA modifications

  5. Frequency of incidental diagnoses discovered at CTA [3 years]

    Frequency and description of incidental diagnoses discovered at CTA

  6. Frequency of modifications per patient [3 years]

    Frequency of different modifications for each axis and within each axis per patient

  7. Calculation of the cost [3 years]

    Calculation of the cost before and after CTA estimated a posteriori on the basis of the consultation rate

  8. Rates for the examinations and therapies [3 years]

    the rates for the examinations and therapies described

  9. Frequency with which CTA [3 years]

    For each doctor: the frequency with which CTA is carried out in his professional practice

  10. Time taken to carry out the CTA [3 years]

    For each doctor: the time taken to carry out the CTA

  11. Average number of ultrasound prints [3 years]

    For each doctor: the average number of ultrasound image prints

  12. Time taken to produce an CTA report [3 years]

    For each doctor: the time taken to produce an CTA report

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Person who has received full information on the organization of the research and has given his/her consent

  • Be over 18 years of age

  • Present a symptomatology leading to suspicion of musculoskeletal pathology

  • Be able to give consent

  • Be affiliated to a social security scheme or benefit from such a scheme

Exclusion Criteria:
  • Chronic inflammatory rheumatism (rheumatoid arthritis, spondylitis, psoriatic arthritis, rheumatoid pseudo-polyarthritis, juvenile idiopathic arthritis, lupus, etc.).

  • Subjects benefiting from a legal protection measure (guardianship, curatorship, safeguard of justice).

  • Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care under articles L3212-1 and L3213-1.

  • Pregnant women

  • Nursing mothers

Contacts and Locations

Locations

Site City State Country Postal Code
1 Central Hospital Nancy Vandoeuvre Lès Nancy France 54500

Sponsors and Collaborators

  • Central Hospital, Nancy, France
  • University of Lorraine

Investigators

  • Principal Investigator: Boris Gass, Pr, Central Hospital, Nancy, France

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
GASS Boris, Principal Investigator, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT06068595
Other Study ID Numbers:
  • 2023-A01995-40
First Posted:
Oct 5, 2023
Last Update Posted:
Oct 5, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by GASS Boris, Principal Investigator, Central Hospital, Nancy, France
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2023