Does Shoulder Stabilizations Stabilize Shoulders?

NCT02725333 | Completed DMC

• 1 other identifier: AMG 12-18
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: There is no evidence that shoulder stabilization effectively corrects the glenohumeral translation in unstable shoulders, explaining residual apprehension in certain patients. The purpose of this study was to analyze the effect of surgical stabilization on glenohumeral translation. Methods: Anteroposterior and superoinferior translations were assessed in patients, before and after shoulder stabilization, through a dedicated patient-specific measurement technique based on optical motion capture and computed tomography.

Conditions

Shoulder Dislocation; Shoulder Pain; Joint Instability Syndrome

Keywords

Glenohumeral stabilization; Computer tomography; Subtle or minor instability; Unstable painful shoulder; Apprehension; Dislocation; Subluxation; Kinematics modeling; Biomechanics; Motion capture; 3D simulation

Outcome Measures

Primary Outcomes (2)

• Comparison of ipsilateral glenohumeral translation (unstable side) pre- and postoperatively.

  Percentage of glenohumeral translation.

  1 year

• Comparison of glenohumeral translation between ipsilateral side (unstable side) and contralateral (stable) side.

  Percentage of glenohumeral translation

  1 year

Secondary Outcomes (2)

• Prevalence of postoperative apprehension, new dislocation or subluxation in relation to the main outcomes of interest.

  1 year

• Range of motion

  1 year

Other Outcomes (1)

• Age, sex, shoulder side, and limb dominance

  1 year

Study Arms (1)

Shoulder Stabilization

OTHER

Anteroposterior and superoinferior translations were assessed in patients, before and after shoulder stabilization, through a dedicated patient-specific measurement technique based on optical motion capture and computed tomography.

Procedure: Shoulder Stabilization

Interventions

Shoulder Stabilization PROCEDURE

Open Latarjet was performed as the standard and well-described Latarjet-Patte procedure with subscapularis split and triple locking mechanism.14 The graft was intra-articular in every case, the capsule was systematically reattached to glenoid according to Favard's modification,15 and a capsular shift was added. Arthroscopic Latarjet was carried out in one case according to a modified Lafosse technique.16 In the latter treatment option, no reattachment of the capsule was realized. The arthroscopic Bankart repair consisted in a mobilization of the anteroinferior capsule and the labrum with an arthroscopic elevator. The glenoid rim and neck were then prepared with a mechanical shaver device. Two loaded anchors were inserted at the 5 and 3 o'clock position, and sutures were shuttled across the inferior glenohumeral ligament and labrum, starting at the inferior position and progressing in a superior direction.

Also known as: Open Latarjet, Arthroscopic Latarjet, Bankart

Shoulder Stabilization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Anteroinferior shoulder stabilization

You may not qualify if:

• Incomplete documentation
• Follow-up of less than twelve months
• History of bilateral instability
• Previous shoulder surgery
• Contraindications for computed tomography
• Non-traumatic onset
• Hyperlaxity. The latter was defined as more than 85° of external rotation at the elbow against the waist{Coudane, 2000 #3124} or hyperabduction by more than 105°.{Gagey, 2001 #1915}

Sponsors & Collaborators

• La Tour Hospital: lead

Related Publications (24)

• Romeo AA, Cohen BS, Carreira DS. Traumatic anterior shoulder instability. Orthop Clin North Am. 2001 Jul;32(3):399-409. doi: 10.1016/s0030-5898(05)70209-1. No abstract available.

  PMID: 11888135 BACKGROUND

• Hovelius L, Vikerfors O, Olofsson A, Svensson O, Rahme H. Bristow-Latarjet and Bankart: a comparative study of shoulder stabilization in 185 shoulders during a seventeen-year follow-up. J Shoulder Elbow Surg. 2011 Oct;20(7):1095-101. doi: 10.1016/j.jse.2011.02.005. Epub 2011 May 24.

  PMID: 21602067 BACKGROUND

• Ladermann A, Lubbeke A, Stern R, Cunningham G, Bellotti V, Gazielly DF. Risk factors for dislocation arthropathy after Latarjet procedure: a long-term study. Int Orthop. 2013 Jun;37(6):1093-8. doi: 10.1007/s00264-013-1848-y. Epub 2013 Mar 13.

  PMID: 23508865 BACKGROUND

• Hovelius L, Sandstrom B, Saebo M. One hundred eighteen Bristow-Latarjet repairs for recurrent anterior dislocation of the shoulder prospectively followed for fifteen years: study II-the evolution of dislocation arthropathy. J Shoulder Elbow Surg. 2006 May-Jun;15(3):279-89. doi: 10.1016/j.jse.2005.09.014.

  PMID: 16679226 BACKGROUND

• Meller R, Krettek C, Gosling T, Wahling K, Jagodzinski M, Zeichen J. Recurrent shoulder instability among athletes: changes in quality of life, sports activity, and muscle function following open repair. Knee Surg Sports Traumatol Arthrosc. 2007 Mar;15(3):295-304. doi: 10.1007/s00167-006-0114-x. Epub 2006 Jun 21.

  PMID: 16816984 BACKGROUND

• Boileau P, Villalba M, Hery JY, Balg F, Ahrens P, Neyton L. Risk factors for recurrence of shoulder instability after arthroscopic Bankart repair. J Bone Joint Surg Am. 2006 Aug;88(8):1755-63. doi: 10.2106/JBJS.E.00817.

  PMID: 16882898 BACKGROUND

• Cunningham G, Zanchi D, Emmert K, Kopel R, Van De Ville D, Ladermann A, Haller S, Hoffmeyer P. Neural Correlates of Clinical Scores in Patients with Anterior Shoulder Apprehension. Med Sci Sports Exerc. 2015 Dec;47(12):2612-20. doi: 10.1249/MSS.0000000000000726.

  PMID: 26110696 BACKGROUND

• Haller S, Cunningham G, Laedermann A, Hofmeister J, Van De Ville D, Lovblad KO, Hoffmeyer P. Shoulder apprehension impacts large-scale functional brain networks. AJNR Am J Neuroradiol. 2014 Apr;35(4):691-7. doi: 10.3174/ajnr.A3738. Epub 2013 Oct 3.

  PMID: 24091445 BACKGROUND

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  PMID: 26133290 BACKGROUND

• Patte D, Bernageau J, Rodineau J, Gardes JC. [Unstable painful shoulders (author's transl)]. Rev Chir Orthop Reparatrice Appar Mot. 1980 Apr-May;66(3):157-65. French.

  PMID: 6450978 BACKGROUND

• Charbonnier C, Chague S, Kolo FC, Chow JC, Ladermann A. A patient-specific measurement technique to model shoulder joint kinematics. Orthop Traumatol Surg Res. 2014 Nov;100(7):715-9. doi: 10.1016/j.otsr.2014.06.015. Epub 2014 Oct 3.

  PMID: 25281547 BACKGROUND

• Coudane H, Walch G, Sebesta A. [Chronic anterior instability of the shoulder in adults. Methodology]. Rev Chir Orthop Reparatrice Appar Mot. 2000 Sep;86 Suppl 1:94-5. No abstract available. French.

  PMID: 11084503 BACKGROUND

• Gagey OJ, Gagey N. The hyperabduction test. J Bone Joint Surg Br. 2001 Jan;83(1):69-74. doi: 10.1302/0301-620x.83b1.10628.

  PMID: 11245541 BACKGROUND

• Young AA, Maia R, Berhouet J, Walch G. Open Latarjet procedure for management of bone loss in anterior instability of the glenohumeral joint. J Shoulder Elbow Surg. 2011 Mar;20(2 Suppl):S61-9. doi: 10.1016/j.jse.2010.07.022. Epub 2010 Dec 9. No abstract available.

  PMID: 21145262 BACKGROUND

• Bouju Y, Gadea F, Stanovici J, Moubarak H, Favard L. Shoulder stabilization by modified Latarjet-Patte procedure: results at a minimum 10 years' follow-up, and role in the prevention of osteoarthritis. Orthop Traumatol Surg Res. 2014 Jun;100(4 Suppl):S213-8. doi: 10.1016/j.otsr.2014.03.010. Epub 2014 Apr 3.

  PMID: 24703796 BACKGROUND

• Cunningham G, Benchouk S, Kherad O, Ladermann A. Comparison of arthroscopic and open Latarjet with a learning curve analysis. Knee Surg Sports Traumatol Arthrosc. 2016 Feb;24(2):540-5. doi: 10.1007/s00167-015-3910-3. Epub 2015 Dec 12.

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• 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.

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• Charbonnier C, Chague S, Kolo FC, Ladermann A. Shoulder motion during tennis serve: dynamic and radiological evaluation based on motion capture and magnetic resonance imaging. Int J Comput Assist Radiol Surg. 2015 Aug;10(8):1289-97. doi: 10.1007/s11548-014-1135-4. Epub 2014 Dec 14.

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• Ladermann A, Chague S, Kolo FC, Charbonnier C. Kinematics of the shoulder joint in tennis players. J Sci Med Sport. 2016 Jan;19(1):56-63. doi: 10.1016/j.jsams.2014.11.009. Epub 2014 Nov 15.

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MeSH Terms

Conditions

Shoulder Dislocation; Shoulder Pain; Joint laxity, familial; Joint Dislocations

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: April 1, 2016
• Study Start: October 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2016
• Last Updated: May 19, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share