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

Kuopio University Hospital39 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acromioclavicular Joint Dislocation Surgical Procedures, Operative

Interventions

Non-surgical groupPROCEDURE

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 groupPROCEDURE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Kuopio University Hospital

Kuopio, Kuopio, Finland

Outcomes

Primary Outcomes

Presence of delayed surgical procedure to treat the AC joint dislocation pathology

Time frame: from 18 to 20 years

Secondary Outcomes

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

Data from ClinicalTrials.gov

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