Fluoroscopic Endobutton in Clavicle Fractures and AC Dislocations (KAT)

Prospective Study on the Interest of Using an Endobutton Under Fluoroscopic Control Alone to Treat Lateral Quarter Clavicle Fractures and Severe Acromioclavicular Dislocations

This study aims to inform clinical decision-making by thoroughly examining the outcomes of different treatment approaches for lateral quarter clavicle fractures and acromioclavicular dislocations. By evaluating the safety and efficacy of Knotless AC TightRope® repair devices and comparing short- and long-term results with other fixation techniques, the investigators hope to contribute to the improvement of treatment protocols for these common shoulder injuries. This research could significantly impact patients' quality of life by enabling optimal recovery and restoration of shoulder function.

Study Overview

• Status: Recruiting
• Conditions: Clavicle Fracture
• Intervention / Treatment: Device: endobutton under fluoroscopic control (Knotless AC TightRope®)

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75116
    • Recruiting
    • Clinique Du Trocadéro
    • Contact: bouchra benkessou, chef de projet; Phone Number: 07 64 48 60 16; Email: b.benkessou@hexagone-sante-paris.fr
    • Contact: Bertrand BAUER, Docteur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients presenting with a fracture of the lateral quarter of the clavicle or a severe acromioclavicular disjunction (Rockwood stages III-V) confirmed by radiological examination
• Patients who have given their consent to participate in the observational study after being informed by the surgeon

Exclusion Criteria:

• Minor patients;
• Subjects who are legally protected adults, under guardianship or trusteeship;
• Infection;
• Pregnant or breastfeeding women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: un seul bras; To evaluate the efficacy of endo-button in the treatment of lateral quarter clavicle fractures and severe acromioclavicular dislocations	Device: endobutton under fluoroscopic control (Knotless AC TightRope®); endobutton under fluoroscopic contro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maintaining acromioclavicular reduction	The effectiveness of the endo-button (Knotless Acromioclavicular TightRope®) in maintaining acromioclavicular reduction at 6 months will be assessed through radiological imaging.	at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the number of postoperative complications	Description of all postoperative events	at 3 weeks, 3months, 6 months and 12 months
Evaluation of the procedure duration	Evaluation of the procedure duration	at day 1
Evaluation of the healing rate	Evaluation of the healing rate	at 6 months
Postoperative pain assessment	Postoperative pain assessment aims to measure the intensity, location, and progression of pain experienced by the patient following surgery. It is essential for adjusting analgesic treatments, improving patient comfort, and preventing chronic pain. This evaluation relies on validated tools such as the Visual Analog Scale (VAS) The Visual Analog Scale (VAS) is a simple and widely used tool for measuring the intensity of pain experienced by a patient. It consists of a horizontal line, typically 10 cm long, with one end representing "no pain" (0) and the other end representing "worst imaginable pain" (10). The patient marks a point on the line that corresponds to their perceived pain level, and the distance from the "no pain" end to the mark is measured in centimeters to yield a score from 0 to 10.	at 3 weeks, 3 months, 6 months ans 12 months
Assessment of shoulder mobility recovery	Assessment of shoulder mobility recovery aims to evaluate functional improvement following surgery or injury. It relies on standardized tools such as the Constant Score, which combines pain, daily activities, range of motion, and muscle strength to provide a comprehensive and objective measure. Additionally, the Subjective Shoulder Value (SSV) offers a simple, patient-reported metric in which the individual rates the function of the affected shoulder as a percentage compared to a normal shoulder, giving a personal perspective on recovery.	at 3 weeks, 3 months, 6 months and 12 months
Assessment of patients' quality of life	Assessment of patients' quality of life is essential for understanding the broader impact of disease and treatment beyond clinical outcomes. The EQ-5D scale is a standardized instrument used to measure health-related quality of life. It evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated by the patient, and the results can be converted into a single index value reflecting overall health status. The EQ-5D also includes a visual analog scale (VAS) where patients rate their perceived health from 0 (worst imaginable) to 100 (best imaginable), providing both objective and subjective insights into their well-being.	at 3 weeks, 3 months , 6 months and 12 months

Collaborators and Investigators

• Sponsor: BOUCHRA BENKESSOU

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: endoprosthesis; acromioclavicular dislocations
• Other Study ID Numbers: 2023-A02204-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No