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NCT Number: NCT07664202

Fluoroscopic Endobutton in Clavicle Fractures and AC 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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Du Trocadéro

Paris, 75116, France

Location status: Recruiting

Location contact

Bertrand BAUER, Docteur

CONTACT

bouchra benkessou, chef de projet

CONTACT

[email protected]

07 64 48 60 16

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

endobutton under fluoroscopic control (Knotless AC TightRope®)

Device

endobutton under fluoroscopic contro

Primary outcomes

  1. maintaining acromioclavicular reduction

    Time frame: at 6 months

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

Secondary outcomes

  1. Assessment of the number of postoperative complications

    Time frame: at 3 weeks, 3months, 6 months and 12 months

    Description of all postoperative events

  2. Evaluation of the procedure duration

    Time frame: at day 1

    Evaluation of the procedure duration

  3. Evaluation of the healing rate

    Time frame: at 6 months

    Evaluation of the healing rate

  4. Postoperative pain assessment

    Time frame: at 3 weeks, 3 months, 6 months ans 12 months

    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.

  5. Assessment of shoulder mobility recovery

    Time frame: at 3 weeks, 3 months, 6 months and 12 months

    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.

  6. Assessment of patients' quality of life

    Time frame: at 3 weeks, 3 months , 6 months and 12 months

    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.

Sponsors and collaborators

Lead sponsor

BOUCHRA BENKESSOU

Other

Registry information

Official study title

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

Acronym: KAT

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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