Skip to main content
OpenTrials
Completed

NCT Number: NCT00840593

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acromioclavicular Joint Dislocation Joint Diseases Joint Dislocations Musculoskeletal Diseases Surgical Procedures, Operative Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kuopio University Hospital

Kuopio, 70211, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-surgical group

Procedure

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 group

Procedure

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.

Primary outcomes

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

    Time frame: from 18 to 20 years

Secondary outcomes

  1. Grading of the AC dislocation using Rockwood classification (3-6)

    Time frame: 18-20 years

  2. AC joint width in the middle of the joint (mm)

    Time frame: 18-20 years

  3. Distance between proc. coracoideus and clavicle (coracoclavicular interspace) in Zanca projection, compared to non-injured side(mm)

    Time frame: 18-20 years

  4. Osteolysis of clavicle (none, mild, moderate, severe) for follow-up radiographs

    Time frame: 18-20 years

  5. Presence of calcification of CC ligaments (yes/no)

    Time frame: 18-20 years

  6. Osteoarthrosis using modified Kellgren-Lawrence classification for follow-up radiographs

    Time frame: 18-20 years

  7. 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

  8. The source (mechanism) of the AC dislocation injury (eg. falling, collision

    Time frame: 0 day

  9. Patient age at the time of injury (years)

    Time frame: 0 day

  10. Patient weight (kg)

    Time frame: 18 - 20 years

  11. Patient length (cm)

    Time frame: 18 - 20 years

  12. Occupation

    Time frame: 18 - 20 years

  13. Grading of the work (light, heavy work, retired)

    Time frame: 18 - 20 years

  14. 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

  15. Larsen score

    Time frame: 18-20 years

  16. Simple Shoulder Test (SST)

    Time frame: 18-20 years

  17. UCLA score

    Time frame: 18-20 years

  18. Constant score

    Time frame: 18-20 years

  19. Oxford score

    Time frame: 18-20 years

  20. 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

  21. Pain (VAS, cm) related to instability experience of AC joint

    Time frame: 18-30 years

  22. Range of motion of the shoulder (flexion, abduction, horizontal adduction, degrees

    Time frame: 18-20 years

  23. Palpation of the AC joint (normal, prominent but stable, unstable)

    Time frame: 18-20 years

  24. Pain of palpation (no or yes)

    Time frame: 18-20 years

  25. Cross arm test (pain in AC joint, no/yes)

    Time frame: 18-20 years

  26. Other pathologic findings of the shoulder in the clinical examination and the description of it

    Time frame: 18-20 years

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 10, 2009
Registry last updated
Dec 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.