NCT06446336

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

May 31, 2024

Last Update Submit

November 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    1 day

Interventions

Creation of a pre-operative score

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who fulfill eligibility criteria

You may qualify if:

  • 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

You may not qualify if:

  • Patient with a ruptured LBT on the pre-operative imaging assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Privé de l'Estuaire

Le Havre, France

RECRUITING

Central Study Contacts

Olivier COURAGE, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2024

First Posted

June 6, 2024

Study Start

May 1, 2024

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations