Efficacy of Two Therapeutic Techniques for the Treatment of Acromioclavicular Dislocations

Not Applicable

Withdrawn

• Conditions: Acromioclavicular Joint Dislocation
• Interventions: Procedure: open reduction internal fixation; Other: sling rest and early functional recovery

• Registration Number: NCT02195219
• Lead Sponsor: Hospital General Universitario Gregorio Marañon

Brief Summary

The aim of this study is to compare two therapeutical procedures for the grade III acromioclavicular dislocations, either open reduction and internal fixation with a coracoclavicular device (MINAR-STORZ ) or non operative treatment.

For these purpose we have designed an interventional, prospective, parallel assignment, opened and randomized study.

Detailed Description

Acromioclavicular dislocations are one of the most frequent traumatic lesions of the scapular girdle. They represent the 40-50% of the sport related shoulder injuries.

There are different grades of dislocations being classified by Altman- Rockwood in 6 types. There is consensus for non operative treatment in types 1 and 2 and for surgical treatment in types 4, 5 and 6.

For type 3 both therapeutic techniques are accepted with no high scientific evidence studies supporting either of them.

During de 70's, surgical treatment was recommended for all these lesions but in the early 90´s surgeons´s preferences changed into the non-operative treatment. Now a day, treatment is decided according to the surgeon experience and the functional demands of the patient.

The aim of this study is to compare the results of non-operative treatment and open reduction and internal fixation with a coracoclavicular reconstruction device (MINAR-STORZ) in grade III acromioclavicular dislocations.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-10
• Study First Submitted QC: 2014-07-16
• Study First Posted: 2014-07-21
• Status Verified: 2017-03
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2018-03-15
• Last Update Posted: 2018-03-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age between 18 and 50 years.
• Grade III acromioclavicular dislocation.
• Signed informed consent.

Exclusion Criteria

• Any condition that may impair the functional recovery or the patient collaboration with the rehabilitation program (cognitive disability, neurological pathology, tumoral disease...).
• Previous acromioclavicular osteoarthritis.
• Previous acromioclavicular lesions.
• Concomitant lesions in the ipsilateral limb or in the contralateral shoulder.
• Polytraumatized patients.
• Any disease or condition the investigator finds decisive for exclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
open reduction internal fixation	open reduction internal fixation	open reduction internal fixation
non operative treatment	sling rest and early functional recovery	'sling rest and early functional recovery

Primary Outcome Measures

Name	Time	Method
Efficacy	12 months	Efficacy will be measured for the AMERICAN SHOULDER AND ELBOW SURGEONS EVALUATION (ASES) and the CONSTANT score.

Secondary Outcome Measures

Name	Time	Method
X-ray evaluation	12 months	X-ray evaluation of the patients who underwent open reduction and internal fixation treatment, comparing the results with the contralateral shoulder and with the preoperative images: 1. Width of the acromioclavicular joint in millimetres, before and after surgery.; 2. Coracoclavicular distance, in millimetres, of the injured joint (the closest distance between these two structures) before and after surgery.; 3. Vertical displacement distance of the clavicle, in millimetres, to the tangent line along the inferior edge of the acromioclavicular joint, before and after surgery.

Trial Locations

Locations (1)

Servicio de Cirugía Ortopédica y Traumatología, HGU Gregorio Maranon; 🇪🇸 Madrid, Spain