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Immobilization in External Rotation of Acute Shoulder Dislocations

Primary Purpose

Anterior Shoulder Dislocation

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Immobilization in External Rotation
Sponsored by
Fowler Kennedy Sport Medicine Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Shoulder Dislocation focused on measuring Immobilization in External Rotation, Acute primary anterior shoulder dislocation

Eligibility Criteria

15 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fowler Kennedy Sport Medicine Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

exernal rotation

Arm Description

external rotation at 90 degrees

Outcomes

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)

Full Information

First Posted
September 12, 2005
Last Updated
November 26, 2015
Sponsor
Fowler Kennedy Sport Medicine Clinic
Collaborators
The Physicians' Services Incorporated Foundation, American Shoulder and Elbow Surgeons
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1. Study Identification

Unique Protocol Identification Number
NCT00196560
Brief Title
Immobilization in External Rotation of Acute Shoulder Dislocations
Official Title
A Randomized Evaluation of Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fowler Kennedy Sport Medicine Clinic
Collaborators
The Physicians' Services Incorporated Foundation, American Shoulder and Elbow Surgeons

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Shoulder Dislocation
Keywords
Immobilization in External Rotation, Acute primary anterior shoulder dislocation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
exernal rotation
Arm Type
Experimental
Arm Description
external rotation at 90 degrees
Intervention Type
Device
Intervention Name(s)
Immobilization in External Rotation
Primary Outcome Measure Information:
Title
Recurrent Instability at 24 months
Secondary Outcome Measure Information:
Title
Time (weeks) to return to work and time(weeks) to return to sport
Title
Complications (resulting from immobilization)
Title
Compliance with immobilization protocol
Title
Western Ontario Shoulder Instability index (WOSI)
Title
American Shoulder and Elbow Surgeons questionnaire (ASES)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert B Litchfield, MD, FRCS(C)
Organizational Affiliation
Fowler Kennedy Sport Medicine Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fowler Kennedy Sport Medicine Clinic
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
5365161
Citation
Kazar B, Relovszky E. Prognosis of primary dislocation of the shoulder. Acta Orthop Scand. 1969;40(2):216-24. doi: 10.3109/17453676908989501. No abstract available.
Results Reference
background
PubMed Identifier
13367074
Citation
ROWE CR. Prognosis in dislocations of the shoulder. J Bone Joint Surg Am. 1956 Oct;38-A(5):957-77. No abstract available.
Results Reference
background
PubMed Identifier
9850776
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. doi: 10.1177/03635465980260060501.
Results Reference
background
PubMed Identifier
6476187
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. doi: 10.1177/036354658401200408.
Results Reference
background
PubMed Identifier
7114346
Citation
Henry JH, Genung JA. Natural history of glenohumeral dislocation--revisited. Am J Sports Med. 1982 May-Jun;10(3):135-7. doi: 10.1177/036354658201000301.
Results Reference
background
PubMed Identifier
12130413
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. doi: 10.1177/03635465020300041801.
Results Reference
background
PubMed Identifier
624747
Citation
Rowe CR, Patel D, Southmayd WW. The Bankart procedure: a long-term end-result study. J Bone Joint Surg Am. 1978 Jan;60(1):1-16.
Results Reference
background
PubMed Identifier
8934481
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. doi: 10.2106/00004623-199611000-00006.
Results Reference
background
PubMed Identifier
6018942
Citation
McLaughlin HL, MacLellan DI. Recurrent anterior dislocation of the shoulder. II. A comparative study. J Trauma. 1967 Mar;7(2):191-201. doi: 10.1097/00005373-196703000-00002. No abstract available.
Results Reference
background
PubMed Identifier
6703178
Citation
Simonet WT, Cofield RH. Prognosis in anterior shoulder dislocation. Am J Sports Med. 1984 Jan-Feb;12(1):19-24. doi: 10.1177/036354658401200103.
Results Reference
background
PubMed Identifier
2775396
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. doi: 10.1016/0749-8063(89)90174-6.
Results Reference
background
PubMed Identifier
11573917
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. doi: 10.1177/03635465010290051101.
Results Reference
background
PubMed Identifier
7810780
Citation
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.
Results Reference
background
PubMed Identifier
10424554
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. doi: 10.1053/ar.1999.v15.015050.
Results Reference
background
PubMed Identifier
10795677
Citation
Arciero RA. Acute arthroscopic Bankart repair? Knee Surg Sports Traumatol Arthrosc. 2000;8(2):127-9. doi: 10.1007/s001670050199. No abstract available.
Results Reference
background
PubMed Identifier
12884846
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. doi: 10.1007/s00167-003-0357-8. No abstract available.
Results Reference
background
PubMed Identifier
15650667
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. doi: 10.1016/j.arthro.2004.09.018.
Results Reference
background
PubMed Identifier
11379734
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(5):661-7. doi: 10.2106/00004623-200105000-00003.
Results Reference
background
PubMed Identifier
14564258
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. doi: 10.1016/s1058-2746(03)00171-x.
Results Reference
background
Citation
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.
Results Reference
background
Citation
Donner, A. Epidemiology 560B course notes. UWO, January 2003.
Results Reference
background
PubMed Identifier
12469084
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. doi: 10.1067/mse.2002.127096.
Results Reference
background
PubMed Identifier
8773720
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. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L. Erratum In: Am J Ind Med 1996 Sep;30(3):372.
Results Reference
background
PubMed Identifier
3791738
Citation
Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
Results Reference
background
PubMed Identifier
24385033
Citation
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.
Results Reference
derived

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Immobilization in External Rotation of Acute Shoulder Dislocations

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