- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00840593
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.
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kuopio, Finland, 70211
- Kuopio University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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)
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.
|
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.
|
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
Time Frame: from 18 to 20 years
|
from 18 to 20 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Grading of the AC dislocation using Rockwood classification (3-6)
Time Frame: 18-20 years
|
18-20 years
|
AC joint width in the middle of the joint (mm)
Time Frame: 18-20 years
|
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
|
18-20 years
|
Osteolysis of clavicle (none, mild, moderate, severe) for follow-up radiographs
Time Frame: 18-20 years
|
18-20 years
|
Presence of calcification of CC ligaments (yes/no)
Time Frame: 18-20 years
|
18-20 years
|
Osteoarthrosis using modified Kellgren-Lawrence classification for follow-up radiographs
Time Frame: 18-20 years
|
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
|
18-20 years
|
The source (mechanism) of the AC dislocation injury (eg. falling, collision
Time Frame: 0 day
|
0 day
|
Patient age at the time of injury (years)
Time Frame: 0 day
|
0 day
|
Patient weight (kg)
Time Frame: 18 - 20 years
|
18 - 20 years
|
Patient length (cm)
Time Frame: 18 - 20 years
|
18 - 20 years
|
Occupation
Time Frame: 18 - 20 years
|
18 - 20 years
|
Grading of the work (light, heavy work, retired)
Time Frame: 18 - 20 years
|
18 - 20 years
|
Presence of other pathologic conditions or operative treatments for the shoulder, AC joint or other part of shoulder, description of it
Time Frame: 18 - 20 years
|
18 - 20 years
|
Larsen score
Time Frame: 18-20 years
|
18-20 years
|
Simple Shoulder Test (SST)
Time Frame: 18-20 years
|
18-20 years
|
UCLA score
Time Frame: 18-20 years
|
18-20 years
|
Constant score
Time Frame: 18-20 years
|
18-20 years
|
Oxford score
Time Frame: 18-20 years
|
18-20 years
|
Instability experiences of the AC joint (none, sometimes = less than 10 times a year, often = more than 10 times year)
Time Frame: 18-20 years
|
18-20 years
|
Pain (VAS, cm) related to instability experience of AC joint
Time Frame: 18-30 years
|
18-30 years
|
Range of motion of the shoulder (flexion, abduction, horizontal adduction, degrees
Time Frame: 18-20 years
|
18-20 years
|
Palpation of the AC joint (normal, prominent but stable, unstable)
Time Frame: 18-20 years
|
18-20 years
|
Pain of palpation (no or yes)
Time Frame: 18-20 years
|
18-20 years
|
Cross arm test (pain in AC joint, no/yes)
Time Frame: 18-20 years
|
18-20 years
|
Other pathologic findings of the shoulder in the clinical examination and the description of it
Time Frame: 18-20 years
|
18-20 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KUH5203037
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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