Immobilization in External Rotation of Acute Shoulder Dislocations - Full Text View

Purpose

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.

Condition	Intervention	Phase
Anterior Shoulder Dislocation	Device: Immobilization in External Rotation	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	A Randomized Evaluation of Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder

Resource links provided by NLM:

MedlinePlus related topics: Dislocations Shoulder Injuries and Disorders Sports Fitness

U.S. FDA Resources

Further study details as provided by Fowler Kennedy Sport Medicine Clinic:

Primary Outcome Measures:

Recurrent Instability at 24 months

Secondary Outcome Measures:

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)

Estimated Enrollment:	50
Study Start Date:	September 2003
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	15 Years to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196560

Locations

Canada, Ontario
Fowler Kennedy Sport Medicine Clinic
London, Ontario, Canada, N6A 3K7

Sponsors and Collaborators

Fowler Kennedy Sport Medicine Clinic

The Physicians' Services Incorporated Foundation

American Shoulder and Elbow Surgeons

Investigators

Principal Investigator:

Robert B Litchfield, MD, FRCS(C)

Fowler Kennedy Sport Medicine Clinic

More Information

Publications:

Kazar B, Relovszky E. Prognosis of primary dislocation of the shoulder. Acta Orthop Scand. 1969;40(2):216-24. No abstract available.

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

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.

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.

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

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.

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

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.

McLaughlin HL, MacLellan DI. Recurrent anterior dislocation of the shoulder. II. A comparative study. J Trauma. 1967 Mar;7(2):191-201. No abstract available.

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

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.

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.

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.

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.

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

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

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.

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.

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.

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.

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.

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

Responsible Party:	Elizabeth Wambolt, FKSMC
ClinicalTrials.gov Identifier:	NCT00196560 History of Changes
Other Study ID Numbers:	FKSMC PSI ERAADS
Study First Received:	September 12, 2005
Last Updated:	January 28, 2009
Health Authority:	Canada: Health Canada

Keywords provided by Fowler Kennedy Sport Medicine Clinic:

Immobilization in External Rotation
Acute primary anterior shoulder dislocation

Additional relevant MeSH terms:

Dislocations
Shoulder Dislocation
Wounds and Injuries
Arm Injuries

ClinicalTrials.gov processed this record on May 16, 2013