Efficacy of Two Therapeutic Techniques for the Treatment of Acromioclavicular Dislocations

NCT02195219 | Withdrawn

• 1 other identifier: ACLUX-3
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acromioclavicular Joint Dislocation

Keywords

conservative; treatment; surgical; Acromioclavicular; Joint; dislocation

Outcome Measures

Primary Outcomes (1)

• Efficacy

  Efficacy will be measured for the AMERICAN SHOULDER AND ELBOW SURGEONS EVALUATION (ASES) and the CONSTANT score.

  12 months

Secondary Outcomes (1)

• X-ray evaluation

  12 months

Study Arms (2)

open reduction internal fixation

EXPERIMENTAL

open reduction internal fixation

Procedure: open reduction internal fixation

non operative treatment

ACTIVE COMPARATOR

'sling rest and early functional recovery

Other: sling rest and early functional recovery

Interventions

open reduction internal fixation 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.

open reduction internal fixation

sling rest and early functional recovery OTHER

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

non operative treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon: lead

Study Sites (1)

Servicio de Cirugía Ortopédica y Traumatología, HGU Gregorio Maranon

Madrid, 28007, Spain

Location

MeSH Terms

Conditions

Joint Dislocations

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Study Officials

• Mikel Aburto, MD

  Hospital Heneral Universitario Gregorio Maranon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 21, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 16, 2018

Record last verified: 2017-03

Locations

ES (1)