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

Surgical Procedures, Operative Clinical Trial

Official title:

A Prospective, Randomised 18 -Year Follow-up Study of Operative and Non-operative Treatment of Acute, Total Acromioclavicular Dislocation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00840593
• Other study ID #: KUH5203037
• Status: Completed
• Phase: N/A
• First received: February 9, 2009
• Last updated: December 7, 2011
• Start date: February 2009
• Est. completion date: August 2009

Study information

• Verified date: December 2011
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ministry of Social Affairs and Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acromioclavicular Joint
• Dislocation
• Dislocations
• Surgical Procedures, Operative

Intervention

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.
• 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.

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

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