Efficacy of Two Therapeutic Techniques for the Treatment of Acromioclavicular Dislocations

NCT ID: NCT02195219

Last Updated: 2018-03-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-12-31

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.

Conditions

Acromioclavicular Joint Dislocation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

open reduction internal fixation

open reduction internal fixation

Group Type: EXPERIMENTAL

open reduction internal fixation

Intervention Type: PROCEDURE

MINAR device allows for reduction of the acromioclavicular joint and the reconstruction of coracoclavicular ligaments with a suture cerclage system. Three weeks after surgery a rehabilitation program will be carried out.

non operative treatment

'sling rest and early functional recovery

Group Type: ACTIVE_COMPARATOR

sling rest and early functional recovery

Intervention Type: OTHER

Immobilization with a sling for three weeks and, from this time, the same rehabilitation program will be performed.

Interventions

open reduction internal fixation

MINAR device allows for reduction of the acromioclavicular joint and the reconstruction of coracoclavicular ligaments with a suture cerclage system. Three weeks after surgery a rehabilitation program will be carried out.

Intervention Type: PROCEDURE

sling rest and early functional recovery

Immobilization with a sling for three weeks and, from this time, the same rehabilitation program will be performed.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital General Universitario Gregorio Marañon

OTHER

Sponsor Role: lead

Responsible Party

Carlos Alvarez

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mikel Aburto, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Heneral Universitario Gregorio Maranon

Locations

Servicio de Cirugía Ortopédica y Traumatología, HGU Gregorio Maranon

Madrid, , Spain

Countries

Spain

Other Identifiers

ACLUX-3

Identifier Type: -

Identifier Source: org_study_id