Immobilization in External Rotation of Acute Shoulder Dislocations

NCT00196560 | Completed Phase 3

• 1 other identifier: FKSMC PSI ERAADS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anterior Shoulder Dislocation

Keywords

Immobilization in External Rotation; Acute primary anterior shoulder dislocation

Outcome Measures

Primary Outcomes (1)

• Recurrent Instability at 24 months

Secondary Outcomes (5)

• Time (weeks) to return to work and time(weeks) to return to sport

• Complications (resulting from immobilization)

• Compliance with immobilization protocol

• Western Ontario Shoulder Instability index (WOSI)

• American Shoulder and Elbow Surgeons questionnaire (ASES)

Study Arms (1)

exernal rotation

EXPERIMENTAL

external rotation at 90 degrees

Device: Immobilization in External Rotation

Interventions

Immobilization in External Rotation DEVICE

exernal rotation

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fowler Kennedy Sport Medicine Clinic: lead
• The Physicians' Services Incorporated Foundation: collaborator
• American Shoulder and Elbow Surgeons: collaborator

Study Sites (1)

Fowler Kennedy Sport Medicine Clinic

London, Ontario, N6A 3K7, Canada

Location

Related Publications (25)

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• ROWE CR. Prognosis in dislocations of the shoulder. J Bone Joint Surg Am. 1956 Oct;38-A(5):957-77. No abstract available.

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• 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. doi: 10.1177/03635465980260060501.

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• 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. doi: 10.1177/036354658401200408.

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• 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. doi: 10.1177/03635465020300041801.

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• 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. doi: 10.2106/00004623-199611000-00006.

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  PMID: 6018942 BACKGROUND

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  PMID: 6703178 BACKGROUND

• 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. doi: 10.1016/0749-8063(89)90174-6.

  PMID: 2775396 BACKGROUND

• 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. doi: 10.1177/03635465010290051101.

  PMID: 11573917 BACKGROUND

• 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. doi: 10.1177/036354659402200504.

  PMID: 7810780 BACKGROUND

• 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. doi: 10.1053/ar.1999.v15.015050.

  PMID: 10424554 BACKGROUND

• Arciero RA. Acute arthroscopic Bankart repair? Knee Surg Sports Traumatol Arthrosc. 2000;8(2):127-9. doi: 10.1007/s001670050199. No abstract available.

  PMID: 10795677 BACKGROUND

• Eriksson E. Should first-time traumatic shoulder dislocations undergo an acute stabilization procedure? Knee Surg Sports Traumatol Arthrosc. 2003 Mar;11(2):61-2. doi: 10.1007/s00167-003-0357-8. No abstract available.

  PMID: 12884846 BACKGROUND

• 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. doi: 10.1016/j.arthro.2004.09.018.

  PMID: 15650667 BACKGROUND

• 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(5):661-7. doi: 10.2106/00004623-200105000-00003.

  PMID: 11379734 BACKGROUND

• 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. doi: 10.1016/s1058-2746(03)00171-x.

  PMID: 14564258 BACKGROUND

• 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.

  BACKGROUND

• Donner, A. Epidemiology 560B course notes. UWO, January 2003.

  BACKGROUND

• 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. doi: 10.1067/mse.2002.127096.

  PMID: 12469084 BACKGROUND

• 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. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.

  PMID: 8773720 BACKGROUND

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

  PMID: 3791738 BACKGROUND

• Whelan DB, Litchfield R, Wambolt E, Dainty KN; Joint Orthopaedic Initiative for National Trials of the Shoulder (JOINTS). External rotation immobilization for primary shoulder dislocation: a randomized controlled trial. Clin Orthop Relat Res. 2014 Aug;472(8):2380-6. doi: 10.1007/s11999-013-3432-6.

  PMID: 24385033 DERIVED

MeSH Terms

Interventions

Immobilization

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Robert B Litchfield, MD, FRCS(C)

  Fowler Kennedy Sport Medicine Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: September 1, 2003
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: November 30, 2015

Record last verified: 2015-11

Locations

CA (1)