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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antti Joukainen, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00840593
First received: February 9, 2009
Last updated: December 7, 2011
Last verified: December 2011
  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: 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 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 ] [ Designated as safety issue: No ]

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

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840593

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

No publications provided

Responsible Party: Antti Joukainen, MD, PhD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00840593     History of Changes
Other Study ID Numbers: KUH5203037
Study First Received: February 9, 2009
Last Updated: December 7, 2011
Health Authority: Finland: Ministry of Social Affairs and Health

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

Additional relevant MeSH terms:
Dislocations
Wounds and Injuries

ClinicalTrials.gov processed this record on July 22, 2014