Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446336
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-31
Brief Title:
Creation of a Pre-operative Score the HASS Score for Injuries Reliable Diagnosis of Long Biceps Tendon
Sponsor:
GCS Ramsay Santé pour lEnseignement et la Recherche
Organization:
GCS Ramsay Santé pour lEnseignement et la Recherche
Study Overview
Official Title:
Creation of a Pre-operative Score the HASS Score for Injuries Reliable Diagnosis of Long Biceps Tendon
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HASS
Brief Summary:
The long biceps tendon LBT has a particular anatomical pathway making it fragile due to repeated microtrauma or trauma which can lead to chronic lesions of LBT
Current issue with this pathology is the absence of preoperative effective clinical and paraclinical tools allowing confirmed diagnosis in particular because of its entanglement with other pathologies
This diagnostic uncertainty generates an approximation for LBT therapeutic indications so that therapeutic indications are frequently finalized during glenohumeral arthroscopy
Having a reliable and reproducible diagnostic tool for LBT pathologies would allow an improvement in their surgical load management
In this context this research is based on the hypothesis that the construction of a pre-operative score the HASS score combining pre-operative clinical and paraclinical data would allow to obtain a reliable diagnosis of LBT injuries
Current issue with this pathology is the absence of preoperative effective clinical and paraclinical tools allowing confirmed diagnosis in particular because of its entanglement with other pathologies
This diagnostic uncertainty generates an approximation for LBT therapeutic indications so that therapeutic indications are frequently finalized during glenohumeral arthroscopy
Having a reliable and reproducible diagnostic tool for LBT pathologies would allow an improvement in their surgical load management
In this context this research is based on the hypothesis that the construction of a pre-operative score the HASS score combining pre-operative clinical and paraclinical data would allow to obtain a reliable diagnosis of LBT injuries
Detailed Description:
The long biceps tendon LBT has a particular anatomical pathway making it fragile due to repeated microtrauma or trauma which can lead to chronic lesions of LBT Aging can also worsen damage to this tendon LBT lesions are frequently associated with other pathologies of glenohumeral complex particularly damage to the rotators cuff or subacromial impingements
Current issue with this pathology is the absence of preoperative effective clinical and paraclinical tools allowing confirmed diagnosis in particular because of its entanglement with other pathologies
Isolated clinical tests are numerous and ineffective Ultrasound is a reliable examination for taking LBT volumetric measurements or to diagnose instability but it fails in the diagnosis of cracks and tendinopathy CT scan CT arthrography MRI and MRI arthrography except a few characteristic signs of LBT lesions ignore most of lesions and their analysis is difficult and little reproducible
This diagnostic uncertainty generates an approximation for LBT therapeutic indications so that therapeutic indications are frequently finalized during glenohumeral arthroscopy However more distal lesions in or under the bicipital groove not accessible in arthroscopy are described in the literature
Having a reliable and reproducible diagnostic tool for LBT pathologies would allow an improvement in their surgical load management It would then be possible not to ignore a lesion which is not visible on arthroscopy or conversely not to perform excess gestures on healthy LBT It would allow also to provide clear preoperative information to patient on planned surgical procedures and their consequences
In this context this research is based on the hypothesis that the construction of a pre-operative score the HASS score combining pre-operative clinical and paraclinical data would allow to obtain a reliable diagnosis of LBT injuries
Current issue with this pathology is the absence of preoperative effective clinical and paraclinical tools allowing confirmed diagnosis in particular because of its entanglement with other pathologies
Isolated clinical tests are numerous and ineffective Ultrasound is a reliable examination for taking LBT volumetric measurements or to diagnose instability but it fails in the diagnosis of cracks and tendinopathy CT scan CT arthrography MRI and MRI arthrography except a few characteristic signs of LBT lesions ignore most of lesions and their analysis is difficult and little reproducible
This diagnostic uncertainty generates an approximation for LBT therapeutic indications so that therapeutic indications are frequently finalized during glenohumeral arthroscopy However more distal lesions in or under the bicipital groove not accessible in arthroscopy are described in the literature
Having a reliable and reproducible diagnostic tool for LBT pathologies would allow an improvement in their surgical load management It would then be possible not to ignore a lesion which is not visible on arthroscopy or conversely not to perform excess gestures on healthy LBT It would allow also to provide clear preoperative information to patient on planned surgical procedures and their consequences
In this context this research is based on the hypothesis that the construction of a pre-operative score the HASS score combining pre-operative clinical and paraclinical data would allow to obtain a reliable diagnosis of LBT injuries
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None