Clavicle Fracture
Conditions
Keywords
endoprosthesis, acromioclavicular dislocations
Brief summary
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.
Interventions
DEVICEendobutton under fluoroscopic control (Knotless AC TightRope®)
endobutton under fluoroscopic contro
Sponsors
BOUCHRA BENKESSOU
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| maintaining acromioclavicular reduction | 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
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the number of postoperative complications | at 3 weeks, 3months, 6 months and 12 months | Description of all postoperative events |
| Evaluation of the procedure duration | at day 1 | Evaluation of the procedure duration |
| Evaluation of the healing rate | at 6 months | Evaluation of the healing rate |
| Postoperative pain assessment | 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. |
| Assessment of shoulder mobility recovery | 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. |
| Assessment of patients' quality of life | 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. |
Countries
France
Outcome results
None listed