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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00840593
Enrollment
39
Registered
2009-02-10
Start date
2009-02-28
Completion date
2009-08-31
Last updated
2011-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromioclavicular Joint, Dislocation, Surgical Procedures, Operative

Keywords

Acromioclavicular Joint, Dislocation, Trials, Randomized Clinical, Surgical Procedures, Operative

Brief 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.

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.

Interventions

PROCEDURENon-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.

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.

Sponsors

Kuopio University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Presence of delayed surgical procedure to treat the AC joint dislocation pathologyfrom 18 to 20 years

Secondary

MeasureTime frame
UCLA score18-20 years
Constant score18-20 years
Oxford score18-20 years
Grading of the AC dislocation using Rockwood classification (3-6)18-20 years
AC joint width in the middle of the joint (mm)18-20 years
Distance between proc. coracoideus and clavicle (coracoclavicular interspace) in Zanca projection, compared to non-injured side(mm)18-20 years
Osteolysis of clavicle (none, mild, moderate, severe) for follow-up radiographs18-20 years
Presence of calcification of CC ligaments (yes/no)18-20 years
Osteoarthrosis using modified Kellgren-Lawrence classification for follow-up radiographs18-20 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 it18-20 years
The source (mechanism) of the AC dislocation injury (eg. falling, collision0 day
Patient age at the time of injury (years)0 day
Simple Shoulder Test (SST)18-20 years
Patient length (cm)18 - 20 years
Occupation18 - 20 years
Grading of the work (light, heavy work, retired)18 - 20 years
Presence of other pathologic conditions or operative treatments for the shoulder, AC joint or other part of shoulder, description of it18 - 20 years
Larsen score18-20 years
Instability experiences of the AC joint (none, sometimes = less than 10 times a year, often = more than 10 times year)18-20 years
Pain (VAS, cm) related to instability experience of AC joint18-30 years
Range of motion of the shoulder (flexion, abduction, horizontal adduction, degrees18-20 years
Palpation of the AC joint (normal, prominent but stable, unstable)18-20 years
Pain of palpation (no or yes)18-20 years
Cross arm test (pain in AC joint, no/yes)18-20 years
Other pathologic findings of the shoulder in the clinical examination and the description of it18-20 years
Patient weight (kg)18 - 20 years

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026