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COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure (COLONIA)

Primary Purpose

Compartment Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MyotonPRO
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Compartment Syndrome focused on measuring compartment syndrome, intramuscular punction Versus non invasive assessment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Affiliation to the French National healthcare system
  • French speaking patients
  • Referred for investigation of compartment syndrome causing

Exclusion Criteria:

  • Pregnancy
  • Inability to understand the study goal
  • Patients protected by decision of law
  • Extended dermatosis
  • Coagulation disorder

Sites / Locations

  • Centre hospitalier universitaire

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CCS group

Arm Description

Measurements by intramuscular punction and non invasive tool

Outcomes

Primary Outcome Measures

Diagnostic performance of MyotonPRO
To study the diagnostic performance of tissue stiffness measurement by MyotonPRO at 1 minute post-exercise in patients suspected of anterolateral of leg

Secondary Outcome Measures

Diagnostic performance of MyotonPRO at 1 minute post-exercise
To study the diagnostic performance of the MyotonPRO tissue stiffness measurement variation between rest and 1 minute post-exercise.
Diagnostic performance of MyotonPRO at 5 minute post-exercise
To study the diagnostic performance of the MyotonPRO tissue stiffness measurement variation between rest and 5 minute post-exercise.

Full Information

First Posted
January 28, 2019
Last Updated
April 6, 2023
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT03840434
Brief Title
COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure
Acronym
COLONIA
Official Title
COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure (COLONIA)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 19, 2019 (Actual)
Primary Completion Date
March 27, 2023 (Actual)
Study Completion Date
March 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Chronic Compartment Syndrome (CCS) is a pathology that affects more specifically subjects exposed to repeated movements, particularly in a professional life or sports. The diagnosis is difficult and often delayed. Currently, the reference technique is invasive. It consists of measuring by a intramuscular puncture (IMP) pressure in the offending compartment early after effort (usually between 1 and 5 minutes post-exercise). A value greater than or equal to 30 mmHg in the first 5 minutes is used as a diagnostic criterion for CCS. Other less invasive techniques (scintigraphy) exist but are subject to certain discordances of interpretation. The advent of new assessment tools, like the MyotonPRO, pave the way for a non-invasive diagnostic approach.
Detailed Description
Patients referred for suspected chronic compartment syndrome causing will be included. After signing the consent, the subject will have a clinical and paraclinical examination. Age, sex, height, weight, side of clinical symptomatology will be collected. Medical history current treatments will also be noted. Once the consent is collected, the patient performs, according to the data of the literature and service habits a stress test aimed at triggering the painful symptomatology associated with post-exercise IMP and MyotonPRO measurements as the same time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Compartment Syndrome
Keywords
compartment syndrome, intramuscular punction Versus non invasive assessment

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Each patient will perform a stress test to trigger the painful. Measurements will be done by intramuscular punction as usually, and by non invasive tool : MyotonPRO.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CCS group
Arm Type
Other
Arm Description
Measurements by intramuscular punction and non invasive tool
Intervention Type
Diagnostic Test
Intervention Name(s)
MyotonPRO
Intervention Description
Each patient will perform a stress test to trigger the painful. Measurements will be done by intramuscular punction as usually, and by non invasive tool : MyotonPRO
Primary Outcome Measure Information:
Title
Diagnostic performance of MyotonPRO
Description
To study the diagnostic performance of tissue stiffness measurement by MyotonPRO at 1 minute post-exercise in patients suspected of anterolateral of leg
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Diagnostic performance of MyotonPRO at 1 minute post-exercise
Description
To study the diagnostic performance of the MyotonPRO tissue stiffness measurement variation between rest and 1 minute post-exercise.
Time Frame
3 years
Title
Diagnostic performance of MyotonPRO at 5 minute post-exercise
Description
To study the diagnostic performance of the MyotonPRO tissue stiffness measurement variation between rest and 5 minute post-exercise.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Affiliation to the French National healthcare system French speaking patients Referred for investigation of compartment syndrome causing Exclusion Criteria: Pregnancy Inability to understand the study goal Patients protected by decision of law Extended dermatosis Coagulation disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine BRUNEAU, PhD
Organizational Affiliation
UH Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier universitaire
City
Angers
ZIP/Postal Code
49933
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure

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