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

Kuopio University Hospital

Status: Completed

Conditions: Surgical Procedures, Operative; Acromioclavicular Joint; Dislocation

Treatments: Procedure: Non-surgical group; Procedure: Surgical group

Study type: Interventional

Funder types: Other

Identifiers

NCT00840593

KUH5203037

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

1. Non-surgical group

Active Comparator group

Description:

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.

Treatment:

Procedure: Non-surgical group

2 Surgical group

Active Comparator group

Description:

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.

Treatment:

Procedure: Surgical group