NCT04479397

Sling vs Nothing After Latarjet Procedure

Completed NA Last updated 21 March 2024

What this trial tests

NA trial testing Latarjet Surgery for anterior shoulder instability in Shoulder Dislocation in 86 participants. Completed in 30 September 2023.

Timeline

1 March 2020

Primary endpoint
30 September 2023

30 September 2023

Quick facts

Lead sponsor	Hugo Bothorel
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	86
Start date	1 March 2020
Primary completion	30 September 2023
Estimated completion	30 September 2023
Sites	1 location across Switzerland

Drugs / interventions tested

• Latarjet Surgery for anterior shoulder instability
• No sling in postoperative care

Conditions studied

• Shoulder Dislocation — all drugs for Shoulder Dislocation →

Sponsor

Hugo Bothorel

Who can join

18 and older, any sex, with Shoulder Dislocation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Is sling immobilization necessary after open Latarjet surgery for anterior shoulder instability? A randomized control trial.
   Goetti P, Martinho T, Seurot A, Bothorel H, et al · · 2023 · cited 2× · PMID 36850012 · DOI 10.1186/s13063-023-07180-9
2. Is sling immobilization necessary after open Latarjet surgery for anterior shoulder instability? A randomized control trial.
   Patrick G, Tiago M, Seurot A, Hugo B, et al · · 2022 · DOI 10.21203/rs.3.rs-1800072/v1