Creation of a Pre-operative Score, the HASS Score, for Injuries Reliable Diagnosis of Long Biceps Tendon

NCT ID: NCT06446336

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Biceps Tendon Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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HASS Score

Creation of a pre-operative score

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient with operative indication for tenodesis tenotomy, represented by persistence of clinical signs after medical treatment for more than 6 months
* Patient with shoulder pain lasting more than 6 months

Exclusion Criteria

* Patient with a ruptured LBT on the pre-operative imaging assessment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Privé de l'Estuaire

Le Havre, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Olivier COURAGE, MD

Role: CONTACT

+ 33 2 76 89 97 93

Facility Contacts

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Olivier COURAGE, MD

Role: primary

+ 33 2 76 89 97 93

Other Identifiers

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RGDS-2023-12-010

Identifier Type: -

Identifier Source: org_study_id

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