Efficacy of Two Therapeutic Techniques for the Treatment of Acromioclavicular Dislocations

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Acromioclavicular Joint Dislocation
• Intervention / Treatment: Procedure: open reduction internal fixation; Other: sling rest and early functional recovery

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28007
    • Servicio de Cirugía Ortopédica y Traumatología, HGU Gregorio Maranon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: open reduction internal fixation	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.
Active Comparator: non operative treatment; 'sling rest and early functional recovery	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	Efficacy will be measured for the AMERICAN SHOULDER AND ELBOW SURGEONS EVALUATION (ASES) and the CONSTANT score.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospital General Universitario Gregorio Marañon
• Investigators: Principal Investigator: Mikel Aburto, MD, Hospital Heneral Universitario Gregorio Maranon

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: July 10, 2014
• First Submitted That Met QC Criteria: July 16, 2014
• First Posted (Estimate): July 21, 2014

Study Record Updates

• Last Update Posted (Actual): March 16, 2018
• Last Update Submitted That Met QC Criteria: March 15, 2018
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: treatment; surgical; conservative; dislocation; Joint; Acromioclavicular
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations
• Other Study ID Numbers: ACLUX-3