Efficacy of Two Therapeutic Techniques for the Treatment of Acromioclavicular Dislocations

Acromioclavicular Joint Dislocation Clinical Trial

Official title:

Clinical Trial to Compare the Efficacy of Two Therapeutic Techniques for the Treatment of Acromioclavicular Grade III Dislocations

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02195219
• Other study ID #: ACLUX-3
• Status: Withdrawn
• Phase: N/A
• First received: July 10, 2014
• Last updated: March 15, 2018
• Start date: June 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2017
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acromioclavicular Joint Dislocation

Intervention

Procedure:
• 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.

Other:
• sling rest and early functional recovery
Immobilization with a sling for three weeks and, from this time, the same rehabilitation program will be performed.

Locations

Country	Name	City	State
Spain	Servicio de Cirugía Ortopédica y Traumatología, HGU Gregorio Maranon	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	Efficacy will be measured for the AMERICAN SHOULDER AND ELBOW SURGEONS EVALUATION (ASES) and the CONSTANT score.	12 months
Secondary	X-ray evaluation	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: Width of the acromioclavicular joint in millimetres, before and after surgery.; Coracoclavicular distance, in millimetres, of the injured joint (the closest distance between these two structures) before and after surgery.; Vertical displacement distance of the clavicle, in millimetres, to the tangent line along the inferior edge of the acromioclavicular joint, before and after surgery.	12 months