Clinical trial NCT00840593: A Prospective, Randomised Long-term Follow-up of Operative Versus Non-operative Treatment of Gr. 3 Acromioclavicular Dislocation
Official title: A Prospective, Randomised 18 -Year Follow-up Study of Operative and Non-operative Treatment of Acute, Total Acromioclavicular Dislocation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acromioclavicular Joint
Dislocation
Surgical Procedures, Operative
Keywords: Acromioclavicular Joint
Dislocation
Trials, Randomized Clinical
Surgical Procedures, Operative
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2009-02-10
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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