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Surgical treatment of acute acromioclavicular Dislocations

Surgical treatment of acute acromioclavicular Dislocations with or without ligament transfer. Randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4z9h7nk
Enrollment
Unknown
Registered
2023-05-26
Start date
2023-06-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromioclavicular joint dislocation

Interventions

It is a randomized clinical trial, developed in a single center, with two parallel groups. 28 participants will be included in each group, being allocated in one of two groups (with transfer and witho

Sponsors

Fundação Faculdade de Medicina de São José do Rio Preto
Lead Sponsor
Fundação Faculdade de Medicina de São José do Rio Preto
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Volunteers of both genders with grade IV and V acute traumatic acromioclavicular dislocation; between 18 and 65 years old; no medical contraindications to general anesthesia; who accept informed consent

Exclusion criteria

Exclusion criteria: Individuals under 18 or over 65 years of age; dislocation with more than 21 days of evolution; presenting associated neurovascular lesion diagnosed in the physical exam and complementary exams; head trauma (Glasgow <12); with associated fracture in the ipsilateral upper limb; inability to maintain outpatient clinical follow-up, that is, patients who will not be able to make the necessary returns for the correct follow-up, or because they are institutionalized, or for being followed up in other services, or other reasons that prevent them from performing the returns in consultations scheduled; with medical contraindication for surgery and/or anesthesia; patients who are unable or unwilling to sign the informed consent form

Design outcomes

Primary

MeasureTime frame
The function and symptoms presented by the participants with the method employed will be evaluated using the DASH questionnaire, Disabilities of the arm, shoulder and hand

Secondary

MeasureTime frame
Dislocation recurrenceThose patients who, in the Zanca view, present an increase in the coracoclavicular space greater than 100% in relation to the contralateral side will be considered with recurrent dislocation after surgical treatment;UCLA-modified scores (Modified University of California at Los Angeles) will be used to assess function, satisfaction and quality of life;SF-12 Questionnaire (Short form survey) will be used to assess quality of life after and during treatment ;Return time to activitiesThe return to pre-injury activities, such as work, sport, and usual daily activities, will be analyzed and presented according to the time elapsed between the trauma and the return, calculated in weeks ;Pain will be assessed using the Visual Analog Pain Scale (VAS) and the need for medication reported by the patient will also be analyzed;Patient in need of surgical treatment for treatment of recurrent dislocation after surgical procedure, symptomatic deformity after conservative treatment or intractable pain;Adverse eventsThose patients with perception of cosmetic deformity will be considered with adverse events; with asymptomatic acromioclavicular instability; shoulder stiffness; other events reported by the patient

Countries

Brazil

Contacts

Public ContactOreste Carrazzone

Fundação Faculdade de Medicina de São José do Rio Preto

dr.oreste@hotmail.com+55(17)32015000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)