Immobilization in External Rotation of Acute Shoulder Dislocations

Anterior Shoulder Dislocation Clinical Trial

Official title:

A Randomized Evaluation of Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196560
• Other study ID #: FKSMC PSI ERAADS
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: November 26, 2015
• Start date: September 2003
• Est. completion date: June 2007

Study information

• Verified date: November 2015
• Source: Fowler Kennedy Sport Medicine Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether immobilizing the affected shoulder of first time anterior shoulder dislocation patients in external rotation (vs immobilization in traditional internal rotation) reduces the rate of recurrent dislocations experienced in 24 months.

Description:

Immobilizing the affected shoulder of first time anterior shoulder dislocation patients in external rotation (vs immobilization in traditional internal rotation)should reduce the rate of recurrent dislocations experienced in 24 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 30 Years

Eligibility

Inclusion Criteria:

• skeletally mature patients less than 30 years of age

• sustained an acute, first-time, traumatic anterior dislocation of the shoulder as defined by; i. Mechanism of abduction, external rotation ii. Sudden pain in the shoulder iii. Manipulative reduction required or iv. Radiograph documenting a dislocated joint

• willing to participate in follow-up for at least two years

Exclusion Criteria:

• incompetent or unwilling to consent

• inability or unwillingness to comply with rehabilitative protocol or required follow-up assessments

• previous instability of the affected shoulder

• significant associated fracture (exception Hill Sachs or Bankart lesions)

• concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program

• a history of significant ligamentous laxity or demonstrated multi-directional instability of the contralateral shoulder

• neurovascular compromise of the affected limb

• a medical condition making the patient unable to wear a brace or sling

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Shoulder Dislocation
• Dislocations
• Shoulder Dislocation

Intervention

Device:
• Immobilization in External Rotation

Locations

Country	Name	City	State
Canada	Fowler Kennedy Sport Medicine Clinic	London	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Fowler Kennedy Sport Medicine Clinic	American Shoulder and Elbow Surgeons, The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (23)

Arciero RA, DeBernadino TM. Acute and chronic dislocations of the shoulder. In Norris TR (ed), Orthopaedic Knowledge update: Shoulder and Elbow. Rosemont Il, American Academy of Orthopaedic Surgeons, 1997, pp 69-71.

Arciero RA, Wheeler JH, Ryan JB, McBride JT. Arthroscopic Bankart repair versus nonoperative treatment for acute, initial anterior shoulder dislocations. Am J Sports Med. 1994 Sep-Oct;22(5):589-94. — View Citation

Arciero RA. Acute arthroscopic Bankart repair? Knee Surg Sports Traumatol Arthrosc. 2000;8(2):127-9. — View Citation

Aronen JG, Regan K. Decreasing the incidence of recurrence of first time anterior shoulder dislocations with rehabilitation. Am J Sports Med. 1984 Jul-Aug;12(4):283-91. — View Citation

Bottoni CR, Wilckens JH, DeBerardino TM, D'Alleyrand JC, Rooney RC, Harpstrite JK, Arciero RA. A prospective, randomized evaluation of arthroscopic stabilization versus nonoperative treatment in patients with acute, traumatic, first-time shoulder dislocations. Am J Sports Med. 2002 Jul-Aug;30(4):576-80. — View Citation

Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4. — View Citation

DeBerardino TM, Arciero RA, Taylor DC, Uhorchak JM. Prospective evaluation of arthroscopic stabilization of acute, initial anterior shoulder dislocations in young athletes. Two- to five-year follow-up. Am J Sports Med. 2001 Sep-Oct;29(5):586-92. — View Citation

Eriksson E. Should first-time traumatic shoulder dislocations undergo an acute stabilization procedure? Knee Surg Sports Traumatol Arthrosc. 2003 Mar;11(2):61-2. — View Citation

Henry JH, Genung JA. Natural history of glenohumeral dislocation--revisited. Am J Sports Med. 1982 May-Jun;10(3):135-7. — View Citation

Hovelius L, Augustini BG, Fredin H, Johansson O, Norlin R, Thorling J. Primary anterior dislocation of the shoulder in young patients. A ten-year prospective study. J Bone Joint Surg Am. 1996 Nov;78(11):1677-84. — View Citation

Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. Erratum in: Am J Ind Med 1996 Sep;30(3):372. — View Citation

Itoi E, Hatakeyama Y, Kido T, Sato T, Minagawa H, Wakabayashi I, Kobayashi M. A new method of immobilization after traumatic anterior dislocation of the shoulder: a preliminary study. J Shoulder Elbow Surg. 2003 Sep-Oct;12(5):413-5. — View Citation

Itoi E, Sashi R, Minagawa H, Shimizu T, Wakabayashi I, Sato K. Position of immobilization after dislocation of the glenohumeral joint. A study with use of magnetic resonance imaging. J Bone Joint Surg Am. 2001 May;83-A(5):661-7. — View Citation

Kazár B, Relovszky E. Prognosis of primary dislocation of the shoulder. Acta Orthop Scand. 1969;40(2):216-24. — View Citation

Kirkley A, Griffin S, McLintock H, Ng L. The development and evaluation of a disease-specific quality of life measurement tool for shoulder instability. The Western Ontario Shoulder Instability Index (WOSI). Am J Sports Med. 1998 Nov-Dec;26(6):764-72. — View Citation

Kirkley A, Griffin S, Richards C, Miniaci A, Mohtadi N. Prospective randomized clinical trial comparing the effectiveness of immediate arthroscopic stabilization versus immobilization and rehabilitation in first traumatic anterior dislocations of the shoulder. Arthroscopy. 1999 Jul-Aug;15(5):507-14. — View Citation

Kirkley A, Werstine R, Ratjek A, Griffin S. Prospective randomized clinical trial comparing the effectiveness of immediate arthroscopic stabilization versus immobilization and rehabilitation in first traumatic anterior dislocations of the shoulder: long-term evaluation. Arthroscopy. 2005 Jan;21(1):55-63. — View Citation

McLaughlin HL, MacLellan DI. Recurrent anterior dislocation of the shoulder. II. A comparative study. J Trauma. 1967 Mar;7(2):191-201. — View Citation

Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002 Nov-Dec;11(6):587-94. — View Citation

Rowe CR, Patel D, Southmard WW. The bankart procedure - a study of late results. J Bone Joint Surg (Am) 59: 122, 1977.

ROWE CR. Prognosis in dislocations of the shoulder. J Bone Joint Surg Am. 1956 Oct;38-A(5):957-77. — View Citation

Simonet WT, Cofield RH. Prognosis in anterior shoulder dislocation. Am J Sports Med. 1984 Jan-Feb;12(1):19-24. — View Citation

Wheeler JH, Ryan JB, Arciero RA, Molinari RN. Arthroscopic versus nonoperative treatment of acute shoulder dislocations in young athletes. Arthroscopy. 1989;5(3):213-7. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent Instability at 24 months
Secondary	Time (weeks) to return to work and time(weeks) to return to sport
Secondary	Complications (resulting from immobilization)
Secondary	Compliance with immobilization protocol
Secondary	Western Ontario Shoulder Instability index (WOSI)
Secondary	American Shoulder and Elbow Surgeons questionnaire (ASES)