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A Prospective, Randomised Long-term Follow-up of Operative Versus Non-operative Treatment of Gr. 3 Acromioclavicular Dislocation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00840593
First Posted: February 10, 2009
Last Update Posted: December 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Antti Joukainen, Kuopio University Hospital
  Purpose
The purpose of this study is to compare the long-term clinical and radiological results of operative and conservative treatment of Tossy type 3 acromio-clavicular dislocation.

Condition Intervention
Acromioclavicular Joint Dislocation Surgical Procedures, Operative Procedure: Non-surgical group Procedure: Surgical group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomised 18 -Year Follow-up Study of Operative and Non-operative Treatment of Acute, Total Acromioclavicular Dislocation.

Resource links provided by NLM:


Further study details as provided by Antti Joukainen, Kuopio University Hospital:

Primary Outcome Measures:
  • Presence of delayed surgical procedure to treat the AC joint dislocation pathology [ Time Frame: from 18 to 20 years ]

Secondary Outcome Measures:
  • Grading of the AC dislocation using Rockwood classification (3-6) [ Time Frame: 18-20 years ]
  • AC joint width in the middle of the joint (mm) [ Time Frame: 18-20 years ]
  • Distance between proc. coracoideus and clavicle (coracoclavicular interspace) in Zanca projection, compared to non-injured side(mm) [ Time Frame: 18-20 years ]
  • Osteolysis of clavicle (none, mild, moderate, severe) for follow-up radiographs [ Time Frame: 18-20 years ]
  • Presence of calcification of CC ligaments (yes/no) [ Time Frame: 18-20 years ]
  • Osteoarthrosis using modified Kellgren-Lawrence classification for follow-up radiographs [ Time Frame: 18-20 years ]
  • Other pathologic condition of the shoulder (eg. osteoarthrosis of the glenohumeral joint, elevation of the humerus, calcific deposits of cuff) and the description of it [ Time Frame: 18-20 years ]
  • The source (mechanism) of the AC dislocation injury (eg. falling, collision [ Time Frame: 0 day ]
  • Patient age at the time of injury (years) [ Time Frame: 0 day ]
  • Patient weight (kg) [ Time Frame: 18 - 20 years ]
  • Patient length (cm) [ Time Frame: 18 - 20 years ]
  • Occupation [ Time Frame: 18 - 20 years ]
  • Grading of the work (light, heavy work, retired) [ Time Frame: 18 - 20 years ]
  • Presence of other pathologic conditions or operative treatments for the shoulder, AC joint or other part of shoulder, description of it [ Time Frame: 18 - 20 years ]
  • Larsen score [ Time Frame: 18-20 years ]
  • Simple Shoulder Test (SST) [ Time Frame: 18-20 years ]
  • UCLA score [ Time Frame: 18-20 years ]
  • Constant score [ Time Frame: 18-20 years ]
  • Oxford score [ Time Frame: 18-20 years ]
  • Instability experiences of the AC joint (none, sometimes = less than 10 times a year, often = more than 10 times year) [ Time Frame: 18-20 years ]
  • Pain (VAS, cm) related to instability experience of AC joint [ Time Frame: 18-30 years ]
  • Range of motion of the shoulder (flexion, abduction, horizontal adduction, degrees [ Time Frame: 18-20 years ]
  • Palpation of the AC joint (normal, prominent but stable, unstable) [ Time Frame: 18-20 years ]
  • Pain of palpation (no or yes) [ Time Frame: 18-20 years ]
  • Cross arm test (pain in AC joint, no/yes) [ Time Frame: 18-20 years ]
  • Other pathologic findings of the shoulder in the clinical examination and the description of it [ Time Frame: 18-20 years ]

Enrollment: 39
Study Start Date: February 2009
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. Non-surgical group
The non-surgical treatment consisted of immobilisation of the injured AC-joint in a Kenny-Howard-type splint for four weeks. The patient was encouraged in mobilisation of the elbow several times per day and the mobilisation of the shoulder with pendulum type movements were initiated four weeks after the injury. Active mobilisation of the shoulder was allowed six weeks after the injury.
Procedure: Non-surgical group
The non-surgical treatment consisted of immobilisation of the injured AC-joint in a Kenny-Howard-type splint for four weeks. The patient was encouraged in mobilisation of the elbow several times per day and the mobilisation of the shoulder with pendulum type movements were initiated four weeks after the injury. Active mobilisation of the shoulder was allowed six weeks after the injury.
Active Comparator: 2 Surgical group
The surgical treatment was accomplished within two days after the injury, and it consisted of an open reduction and fixation of the AC joint with two smooth Kirschner wires (2 mm in diameter) across the AC-joint. The K-wires were bent at the proximal ends, with suturing of the superior AC ligament. The position of Kirschner wires was confirmed during the operation using C-arm transillumination. The articular disc of AC joint was removed if it was damaged. Postoperative care consisted of immobilisation of the AC joint in a sling, (Polysling, body band) for four weeks and the mobilisation of the shoulder started four to six weeks later in a similar manner as in the non-operative group.
Procedure: Surgical group
The surgical treatment was accomplished within two days after the injury, and it consisted of an open reduction and fixation of the AC joint with two smooth Kirschner wires (2 mm in diameter) across the AC-joint. The K-wires were bent at the proximal ends, with suturing of the superior AC ligament. The position of Kirschner wires was confirmed during the operation using C-arm transillumination. The articular disc of AC joint was removed if it was damaged. Postoperative care consisted of immobilisation of the AC joint in a sling, (Polysling, body band) for four weeks and the mobilisation of the shoulder started four to six weeks later in a similar manner as in the non-operative group.

Detailed Description:

The optimal treatment of Rockwood type 3 AC joint injuries is still controversial. This controversy results from the low level of evidence of the early literature and the evaluation of all AC joint injuries with a type I through III classification system.

There are no prospective randomized controlled long-term studies on the treatment of Tossy type 3 AC dislocation using primary repair and minimal pin fixation.

In this study, the non-surgical treatment consisted of immobilisation of the injured AC-joint in a Kenny-Howard-type splint for four weeks. The surgical treatment consisted of an open reduction and fixation of the AC joint with two smooth Kirschner wires (2 mm in diameter) across the AC-joint. The K-wires were bent at the proximal ends, with suturing of the superior AC ligament.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with Tossy grade 3 AC-dislocation was recruited between the years 1989 and 1991 at Kuopio University Hospital for a randomized controlled study
  • A written informed consent.

Exclusion Criteria:

  • Not written informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840593


Locations
Finland
Kuopio University Hospital
Kuopio, Finland, 70211
Sponsors and Collaborators
Kuopio University Hospital
  More Information

Responsible Party: Antti Joukainen, MD, PhD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00840593     History of Changes
Other Study ID Numbers: KUH5203037
First Submitted: February 9, 2009
First Posted: February 10, 2009
Last Update Posted: December 8, 2011
Last Verified: December 2011

Keywords provided by Antti Joukainen, Kuopio University Hospital:
Acromioclavicular Joint
Dislocation
Trials, Randomized Clinical
Surgical Procedures, Operative

Additional relevant MeSH terms:
Joint Dislocations
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries