Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
86 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-03-01
Study Completion Date
2023-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Post-operative Mobilisation After Rotator Cuff Repair
NCT02943005
Rotator Cuff
UNKNOWN
NA
The Latarjet-type Procedure Using the SEM Positioner: Using a Scan to Assess Consolidation
NCT02426996
Shoulder Dislocation
TERMINATED
NA
The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair
NCT02050087
Rotator Cuff Rupture
COMPLETED
NA
Prospective Strength Measurement Involving Muscles Altered In Arthroscopic Latarjet
NCT03331510
Shoulder Instability
UNKNOWN
Shoulder Abduction Brace Against Normal Sling After Arthroscopical Rotator Cuff Suture.
NCT03445494
Supraspinatus Injury
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The aim of this study is to compare rehabilitation with the wearing of a sling, to rehabilitation without any immobilization after Latarjet procedure for treatment of anterior shoulder instability. Ultimately, the goal would be to offer to patients a simplified rehabilitation management, with a faster recovery, less pain and a quicker return to activities of daily living, work and sport.
As primary outcome, investigators will evaluate if the Rowe score is superior without postoperative immobilization (without a sling during the first 3 weeks) at 6 months after surgery compared to sling wearing.
Secondary outcomes include radiological criteria (X-rays and computed tomography (CT) at 6 months for bony union), return to sport, work absenteeism, other complication rate (especially redislocation), and the undermentioned subjective and clinical scores before surgery and at 1.5, 6 and 12 postoperative months.
All patients will be assessed with commonly used subjective scores in the form of self-administered questionnaires. The Visual Analog Scale (VAS) is a widely used single-item test where a patient rates pain intensity between 0 and 10. This scale is useful for patient preoperative and postoperative monitoring and has also been correlated with patient pain, anxiety and apprehension. Patient satisfaction (are patients satisfied, yes/no) will be assessed as well. Subjective Shoulder Value (SSV) is a single-question test where a patient is asked to rate his overall shoulder function as a percentage of normal shoulder. It is a quick and easily administered score that has also been validated for various shoulder disabilities, such as instability.
The following clinical scores will be analyzed as well Rowe score for instability is a three-item test with four choices each, measuring shoulder function, stability, and motion. The final result is converted into a value between 0 and 100. These scores have been specifically developed for shoulder instability.
Except for VAS, higher results mean higher function. ROM will be determined using a Vicon motion capture system (Vicon, Oxford Metrics, Oxford, UK) consisting of six cameras sampling at 120 Hz already available in our facility.
As primary outcome, investigators will evaluate if the Rowe score is superior without postoperative immobilization (without a sling during the first 3 weeks) at 6 months after surgery compared to sling wearing.
Secondary outcomes include radiological criteria (X-rays and computed tomography (CT) at 6 months for bony union), return to sport, work absenteeism, other complication rate (especially redislocation), and the undermentioned subjective and clinical scores before surgery and at 1.5, 6 and 12 postoperative months.
All patients will be assessed with commonly used subjective scores in the form of self-administered questionnaires. The Visual Analog Scale (VAS) is a widely used single-item test where a patient rates pain intensity between 0 and 10. This scale is useful for patient preoperative and postoperative monitoring and has also been correlated with patient pain, anxiety and apprehension. Patient satisfaction (are patients satisfied, yes/no) will be assessed as well. Subjective Shoulder Value (SSV) is a single-question test where a patient is asked to rate his overall shoulder function as a percentage of normal shoulder. It is a quick and easily administered score that has also been validated for various shoulder disabilities, such as instability.
The following clinical scores will be analyzed as well Rowe score for instability is a three-item test with four choices each, measuring shoulder function, stability, and motion. The final result is converted into a value between 0 and 100. These scores have been specifically developed for shoulder instability.
Except for VAS, higher results mean higher function. ROM will be determined using a Vicon motion capture system (Vicon, Oxford Metrics, Oxford, UK) consisting of six cameras sampling at 120 Hz already available in our facility.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Shoulder Dislocation
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sling Arm
This arm of the study will receive a sling for 3 weeks in postoperative care.
Group Type
ACTIVE_COMPARATOR
Latarjet Surgery for anterior shoulder instability
Intervention Type
PROCEDURE
Bone block procedure for anterior shoulder instability
No Sling Arm
This arm of the study will not receive a sling during the postoperative care,
Group Type
EXPERIMENTAL
Latarjet Surgery for anterior shoulder instability
Intervention Type
PROCEDURE
Bone block procedure for anterior shoulder instability
No sling in postoperative care
Intervention Type
PROCEDURE
No sling will be used in postoperative care.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Latarjet Surgery for anterior shoulder instability
Bone block procedure for anterior shoulder instability
Intervention Type
PROCEDURE
No sling in postoperative care
No sling will be used in postoperative care.
Intervention Type
PROCEDURE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hugo Bothorel
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hugo Bothorel
Clinical trial supervisor LaTour Hospital
Responsibility Role
SPONSOR_INVESTIGATOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
La Tour Hospital
Meyrin, Canton of Geneva, Switzerland
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Switzerland
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-02469
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Evaluation of Factors Associated With Return to Sports Activity Six Months After Anterior Shoulder Stabilisation With Latarjet.
NCT05010278
COMPLETED
A Prospective Study of the Effect of Treatment of First Time Traumatic Shoulder Anterior Dislocation by Immobilization in External Rotation on the Incidence of Recurrent Dislocation
NCT01648335
UNKNOWN
PHASE2
A Randomized Evaluation of Emergent Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder
NCT02197819
TERMINATED
NA
Reduction of Anterior Glenohumeral Dislocation in Ventral Decubitus Versus Dorsal Decubitus Under Procedural Sedation
NCT04823689
COMPLETED
NA
Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation
NCT02913352
UNKNOWN
NA
Self Reduction of Shoulder Dislocation
NCT02787395
UNKNOWN
NA
Prospective Sensor Controlled Compliance Analysis of Shoulder Abduction Splint After Rotator Cuff Repair
NCT03054753
COMPLETED
NA
Operative Treatment of Traumatic Anteroinferior Shoulder Instability in Young Male Patients
NCT01998048
UNKNOWN
NA
Shoulder Instability Trial Comparing Arthroscopic Stabilization Benefits Compared With Latarjet Procedure Evaluation
NCT03585491
ACTIVE_NOT_RECRUITING
NA
Immobilization in External Rotation of Acute Shoulder Dislocations
NCT00196560
COMPLETED
PHASE3
Abduction Brace Versus Antirotation Sling for Immobilization Following Reverse Shoulder Arthroplasty and Rotator Cuff Repair
NCT03488433
WITHDRAWN
NA
Immobilization in External Rotation After First Time Anterior Shoulder Dislocation
NCT00707018
COMPLETED
NA
Latarjet Procedure: Comparative Outcomes Study of Arthroscopic Versus Mini-open Approach With Minimum 2-year Follow-up
NCT02505932
COMPLETED
Influence of an Anterior Latarjet-type Abutment Operation on Scapular Dyskinesia and the Muscular Stabilization Mechanisms of the Scapula (DyScapLat)
NCT05131126
UNKNOWN
NA
Conservative or Surgical Management of Rockwood Type III to V Acromioclavicular Dislocations
NCT02677441
UNKNOWN
NA
Ability of Rotator Cuff Muscle Strength Levels, Assessed by Isokinetic Dynamometry, to Predict Return to Sport After Shoulder Stabilization Surgery by Open Latarjet Procedure
NCT06602713
NOT_YET_RECRUITING
NA
Influence of the Dominance of the Shoulder Stabilized by the Open Latarjet Procedure on the Functional Recovery of the Shoulder at 4.5 Months Postoperatively.
NCT05150379
UNKNOWN
Early Mobilization Following Arthroscopic Rotator Cuff Repair
NCT01333527
COMPLETED
NA
Influenze of Approach in Reversed Shoulder Prosthesis
NCT04405947
COMPLETED
NA
Immobilization in Reverse Shoulder Prosthesis
NCT04645329
UNKNOWN
NA
Patch Study (Patch-augmented Rotator Cuff Repair)
NCT06076902
RECRUITING
NA
Reproducibility of Functional Shoulder Tests for the Return to Sport of Patients Operated on Previous Shoulder Instability
NCT05084703
UNKNOWN
NA
Stabilization of the Shoulder Joint Using a Latarjet-like Procedure.
NCT06920654
ENROLLING_BY_INVITATION