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.

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.

Study Overview

• Status: Completed
• Conditions: Surgical Procedures, Operative; Acromioclavicular Joint; Dislocation
• Intervention / Treatment: Procedure: Non-surgical group; Procedure: Surgical 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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Kuopio, Finland, 70211
    • Kuopio University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence of delayed surgical procedure to treat the AC joint dislocation pathology	from 18 to 20 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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 radiographs	18-20 years
Presence of calcification of CC ligaments (yes/no)	18-20 years
Osteoarthrosis using modified Kellgren-Lawrence classification for follow-up radiographs	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	18-20 years
The source (mechanism) of the AC dislocation injury (eg. falling, collision	0 day
Patient age at the time of injury (years)	0 day
Patient weight (kg)	18 - 20 years
Patient length (cm)	18 - 20 years
Occupation	18 - 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 it	18 - 20 years
Larsen score	18-20 years
Simple Shoulder Test (SST)	18-20 years
UCLA score	18-20 years
Constant score	18-20 years
Oxford score	18-20 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 joint	18-30 years
Range of motion of the shoulder (flexion, abduction, horizontal adduction, degrees	18-20 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 it	18-20 years

Collaborators and Investigators

• Sponsor: Kuopio University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: February 9, 2009
• First Submitted That Met QC Criteria: February 9, 2009
• First Posted (Estimate): February 10, 2009

Study Record Updates

• Last Update Posted (Estimate): December 8, 2011
• Last Update Submitted That Met QC Criteria: December 7, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Surgical Procedures, Operative; Dislocation; Acromioclavicular Joint; Trials, Randomized Clinical
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations
• Other Study ID Numbers: KUH5203037