Biceps Tendon DisorderHASSNCT06446336
Creation of a Pre-operative Score, the HASS Score, for Injuries Reliable Diagnosis of Long Biceps Tendon
An observational study of Biceps Tendon Disorder, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biceps Tendon Disorder
- What is being tested?
- HASS Score
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who fulfill eligibility criteria
Who may be able to join
- 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
Who cannot join
- Patient with a ruptured LBT on the pre-operative imaging assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Privé de l'Estuaire
Le Havre
Olivier COURAGE, MD, + 33 2 76 89 97 93, o.courage@wanadoo.fr
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Biceps Tendon Disorder
- Being tested
- HASS Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HASS ScoreOther
Creation of a pre-operative score
What is being measured
The primary outcome is the main question the study is designed to answer.
HASS score
HASS score will rely on clinical data (Speed test, O'Brien test, palpation of the bicipital groove, Yergason test, Uppercut test, Throwing test and Hourglass test) and imaging data (Scan or CT scan, MRI or arthro-MRI)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biceps Tendon DisorderStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446336
- Sponsor's protocol ID
- RGDS-2023-12-010
- Acronym
- HASS
- Status last verified
- Aug 2026
- First submitted
- 31 May 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Pre-operative Score, the HASS Score, for Injuries Reliable Diagnosis of Long Biceps Tendon
- ClinicalTrials.gov ID
- NCT06446336
- Acronym / sponsor ID
- HASS / RGDS-2023-12-010
- Conditions
- Biceps Tendon Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Jun 2024 (actual)
- 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 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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who fulfill eligibility criteria
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patient with a ruptured LBT on the pre-operative imaging assessment
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 |
|---|---|---|
| HASS ScoreCreation of a pre-operative score | Other | – |
Primary outcome
HASS score
Time frame: 1 day
HASS score will rely on clinical data (Speed test, O'Brien test, palpation of the bicipital groove, Yergason test, Uppercut test, Throwing test and Hourglass test) and imaging data (Scan or CT scan, MRI or arthro-MRI)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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.
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 Biceps Tendon Disorder, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 2 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: looking for participants now, as of the sponsor's last update on 20 Aug 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier COURAGE, MD (+ 33 2 76 89 97 93, o.courage@wanadoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HASS score (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.