Sling vs Nothing After Latarjet Procedure

NCT04479397 | Completed

• 1 other identifier: 2019-02469
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Traumatic anterior shoulder instability is a common injury for the contact athlete, with high rates of recurrence in some athletic populations. The specific indication for the Latarjet procedure differs amongst surgeons, however it is generally accepted that it is indicated in patients with anterior glenohumeral instability that are unlikely to have a successful outcome from either an arthroscopic or open anatomical Bankart repair. Overall the rate of reoperation following a Latarjet is around 5-7%. Infection, hematoma as well as screw removal and glenoid bony rim fractures are the most common indications for reoperation. The rate of instability after a Latarjet is low, with 1.7%-5.0% rate of dislocation. However, in terms of rehabilitation, there are only a few studies and evidence of best practices. A recent review of the literature has highlighted four studies, comparing different rehabilitation protocols, which include different immobilization periods ranging from 0 to 3 weeks, and different types of mobilization (under physiotherapist supervision or not, with machine or not). They found a similar rate of recurrent dislocation between the different protocols. But early passive motion enables to improve the range of motion during first 3-6 months, with similar results at one year. One main aspect which the surgeon can influence is immobilization time. In all above-mentioned studies, patients had to wear a sling for at least 3 weeks, even in the early mobilization groups. Short protocols with encouraging results have been recently emphasized by in other fields of shoulder surgery. The investigators would like to determine if the absence of postoperative immobilization could lead to improved function and better range of motion. To the investigators best knowledge, no study has sought to compare the usefulness of sling wearing after Latarjet procedure. Avoiding the sling could simplify rehabilitation and should provide a return to normal function faster.

Conditions

Shoulder Dislocation

Keywords

Latarjet; Post operative; Sling

Outcome Measures

Primary Outcomes (1)

• Rowe score

  The Rowe Score consists of a total of 100 points divided into three domains: (1) stability, which corresponds to a total 50 points; (2) mobility, which corresponds to 20 points; (3) function, which corresponds to 30 points.

  12 postoperative months

Secondary Outcomes (8)

• The Visual Analog Scale (VAS)

  12 postoperative months

• Subjective Shoulder Value (SSV)

  12 postoperative months

• Patient satisfaction

  12 postoperative months

• Bony union

  12 postoperative months

• Return to work

  12 postoperative months

Study Arms (2)

Sling Arm

ACTIVE COMPARATOR

This arm of the study will receive a sling for 3 weeks in postoperative care.

Procedure: Latarjet Surgery for anterior shoulder instability

No Sling Arm

EXPERIMENTAL

This arm of the study will not receive a sling during the postoperative care,

Procedure: Latarjet Surgery for anterior shoulder instability; Procedure: No sling in postoperative care

Interventions

Latarjet Surgery for anterior shoulder instability PROCEDURE

Bone block procedure for anterior shoulder instability

No Sling Arm; Sling Arm

No sling in postoperative care PROCEDURE

No sling will be used in postoperative care.

No Sling Arm

Eligibility Criteria

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

You may qualify if:

• all patients over 18 years old who have an anterior shoulder instability with one of the following criteria: an anterior glenoid bone defect \> 20%, contact athlete or patients with failed Bankart repair-either open or arthroscopic will be considered eligible.

You may not qualify if:

• We exclude patients with a subscapularis tear, other trauma of the involved upper extremity (e.g. associated scapular or clavicular fractures, acromioclavicular dislocation), pre-operative stiffness, pre-operative sign of dislocation on standard X-ray, CT, CT arthrogram, MRI or MRA, contra-indication to CT (i.e pregnancy), and an inability to follow properly post-surgery recommendations.

Sponsors & Collaborators

• Hugo Bothorel: lead

Study Sites (1)

La Tour Hospital

Meyrin, Canton of Geneva, 1217, Switzerland

Location

Related Publications (22)

• Griesser MJ, Harris JD, McCoy BW, Hussain WM, Jones MH, Bishop JY, Miniaci A. Complications and re-operations after Bristow-Latarjet shoulder stabilization: a systematic review. J Shoulder Elbow Surg. 2013 Feb;22(2):286-92. doi: 10.1016/j.jse.2012.09.009.

  PMID: 23352473 BACKGROUND

• Whitehouse T, Orr R, Fitzgerald E, Harries S, McLellan CP. The Epidemiology of Injuries in Australian Professional Rugby Union 2014 Super Rugby Competition. Orthop J Sports Med. 2016 Mar 22;4(3):2325967116634075. doi: 10.1177/2325967116634075. eCollection 2016 Mar.

  PMID: 27069947 RESULT

• van der Linde JA, van Wijngaarden R, Somford MP, van Deurzen DF, van den Bekerom MP. The Bristow-Latarjet procedure, a historical note on a technique in comeback. Knee Surg Sports Traumatol Arthrosc. 2016 Feb;24(2):470-8. doi: 10.1007/s00167-015-3704-7. Epub 2015 Aug 1.

  PMID: 26231148 RESULT

• An VV, Sivakumar BS, Phan K, Trantalis J. A systematic review and meta-analysis of clinical and patient-reported outcomes following two procedures for recurrent traumatic anterior instability of the shoulder: Latarjet procedure vs. Bankart repair. J Shoulder Elbow Surg. 2016 May;25(5):853-63. doi: 10.1016/j.jse.2015.11.001. Epub 2016 Jan 19.

  PMID: 26809355 RESULT

• Cunningham G, Ladermann A. Redefining anterior shoulder impingement: a literature review. Int Orthop. 2018 Feb;42(2):359-366. doi: 10.1007/s00264-017-3515-1. Epub 2017 Jun 6.

  PMID: 28585076 RESULT

• Ma R, Brimmo OA, Li X, Colbert L. Current Concepts in Rehabilitation for Traumatic Anterior Shoulder Instability. Curr Rev Musculoskelet Med. 2017 Dec;10(4):499-506. doi: 10.1007/s12178-017-9449-9.

  PMID: 29038953 RESULT

• Ialenti MN, Mulvihill JD, Feinstein M, Zhang AL, Feeley BT. Return to Play Following Shoulder Stabilization: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2017 Sep 14;5(9):2325967117726055. doi: 10.1177/2325967117726055. eCollection 2017 Sep.

  PMID: 28944249 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 26658571 RESULT

• Tirefort J, Schwitzguebel AJ, Collin P, Nowak A, Plomb-Holmes C, Ladermann A. Postoperative Mobilization After Superior Rotator Cuff Repair: Sling Versus No Sling: A Randomized Prospective Study. J Bone Joint Surg Am. 2019 Mar 20;101(6):494-503. doi: 10.2106/JBJS.18.00773.

  PMID: 30893230 RESULT

• Domos P, Lunini E, Ascione F, Serra N, Bercik MJ, Neyton L, Godeneche A, Walch G. Clinical and radiographic outcomes of open Latarjet procedure in patients aged 40 years or older. J Shoulder Elbow Surg. 2019 Sep;28(9):e304-e312. doi: 10.1016/j.jse.2019.02.004. Epub 2019 Apr 28.

  PMID: 31043350 RESULT

• Boileau P, Saliken D, Gendre P, Seeto BL, d'Ollonne T, Gonzalez JF, Bronsard N. Arthroscopic Latarjet: Suture-Button Fixation Is a Safe and Reliable Alternative to Screw Fixation. Arthroscopy. 2019 Apr;35(4):1050-1061. doi: 10.1016/j.arthro.2018.11.012. Epub 2019 Mar 8.

  PMID: 30857907 RESULT

• Gilbart MK, Gerber C. Comparison of the subjective shoulder value and the Constant score. J Shoulder Elbow Surg. 2007 Nov-Dec;16(6):717-21. doi: 10.1016/j.jse.2007.02.123.

  PMID: 18061114 RESULT

• Martinez-Urrutia A. Anxiety and pain in surgical patients. J Consult Clin Psychol. 1975 Aug;43(4):437-42. doi: 10.1037/h0076898. No abstract available.

  PMID: 1159142 RESULT

• 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 RESULT

• Jensen KU, Bongaerts G, Bruhn R, Schneider S. Not all Rowe scores are the same! Which Rowe score do you use? J Shoulder Elbow Surg. 2009 Jul-Aug;18(4):511-4. doi: 10.1016/j.jse.2009.02.003.

  PMID: 19559368 RESULT

• Bessiere C, Trojani C, Pelegri C, Carles M, Boileau P. Coracoid bone block versus arthroscopic Bankart repair: a comparative paired study with 5-year follow-up. Orthop Traumatol Surg Res. 2013 Apr;99(2):123-30. doi: 10.1016/j.otsr.2012.12.010. Epub 2013 Mar 6.

  PMID: 23481699 RESULT

• Roulet S, Borel F, Franger G, Liotard JP, Michelet A, Godeneche A. Immediate self-rehabilitation after open Latarjet procedures enables recovery of preoperative shoulder mobility at 3 months. Knee Surg Sports Traumatol Arthrosc. 2019 Dec;27(12):3979-3988. doi: 10.1007/s00167-019-05635-8. Epub 2019 Jul 25.

  PMID: 31346667 RESULT

• Burkhart SS, De Beer JF, Barth JR, Cresswell T, Roberts C, Richards DP. Results of modified Latarjet reconstruction in patients with anteroinferior instability and significant bone loss. Arthroscopy. 2007 Oct;23(10):1033-41. doi: 10.1016/j.arthro.2007.08.009.

  PMID: 17916467 RESULT

• Park I, Oh MJ, Shin SJ. Minimal Clinically Important Differences and Correlating Factors for the Rowe Score and the American Shoulder and Elbow Surgeons Score After Arthroscopic Stabilization Surgery for Anterior Shoulder Instability. Arthroscopy. 2019 Jan;35(1):54-59. doi: 10.1016/j.arthro.2018.08.005.

  PMID: 30611364 RESULT

• Goetti P, Martinho T, Seurot A, Bothorel H, Ladermann A. Is sling immobilization necessary after open Latarjet surgery for anterior shoulder instability? A randomized control trial. Trials. 2023 Feb 27;24(1):148. doi: 10.1186/s13063-023-07180-9.

  PMID: 36850012 DERIVED

MeSH Terms

Conditions

Shoulder Dislocation

Interventions

Postoperative Care

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical trial supervisor LaTour Hospital

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 21, 2020
• Study Start: March 1, 2020
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

CH (1)