BACKGROUND: Immobilization in external rotation is one of the treatment options for an initial dislocation of the shoulder. However, it remains unclear how long it takes for a Bankart lesion to heal. HYPOTHESIS: Protection of a healing Bankart lesion from stretching would promote the healing process and decrease the recurrence rate after an initial dislocation of the shoulder. STUDY DESIGN: Randomized controlled trial; Level of evidence, 2. METHODS: This was a multicenter, prospective randomized study. Between January 2005 and August 2009, 109 patients (71 male and 38 female; mean age, 30 years) with an initial traumatic dislocation of the shoulder were enrolled. After 3 weeks of immobilization in external rotation, a shoulder motion restriction band designed to avoid stretching the anteroinferior shoulder capsule was used for 0 weeks (36 patients), 3 weeks (37 patients), or 6 weeks (36 patients). After using the band, patients were allowed to use their shoulders freely, but they were advised to avoid vigorous sport activities for at least 3 months after the injury. Any recurrent dislocation and return to sports were assessed at 2-year follow-up. RESULTS:Of 109 patients, 90 were followed up for 2 years. The compliance rates were 60% to 72% among the groups (P = .54). The recurrence rate of dislocation was 28% in the 0-week group, 33% in the 3-week group, and 32% in the 6-week group (P = .88) according to the intention-to-treat analysis, and they were a respective 24%, 28%, and 27% according to the per-protocol analysis (P = .95). Based on the sport activity level, the recurrence rates for patients involved in contact sports (7/15, 47%) and those involved in noncontact sports (19/51, 37%) were significantly higher than for those not involved in sport activities (2/24, 8.3%) (P = .0076). Among the 3 groups, there were no significant differences in the recurrence rates. There was no significant difference in the rate of return to sports (P = .39). CONCLUSION: No difference in the recurrence rate was seen with the use of a shoulder motion restriction band after 3 weeks of immobilization in external rotation after an initial dislocation of the shoulder.
RCT Entities:
BACKGROUND: Immobilization in external rotation is one of the treatment options for an initial dislocation of the shoulder. However, it remains unclear how long it takes for a Bankart lesion to heal. HYPOTHESIS: Protection of a healing Bankart lesion from stretching would promote the healing process and decrease the recurrence rate after an initial dislocation of the shoulder. STUDY DESIGN: Randomized controlled trial; Level of evidence, 2. METHODS: This was a multicenter, prospective randomized study. Between January 2005 and August 2009, 109 patients (71 male and 38 female; mean age, 30 years) with an initial traumatic dislocation of the shoulder were enrolled. After 3 weeks of immobilization in external rotation, a shoulder motion restriction band designed to avoid stretching the anteroinferior shoulder capsule was used for 0 weeks (36 patients), 3 weeks (37 patients), or 6 weeks (36 patients). After using the band, patients were allowed to use their shoulders freely, but they were advised to avoid vigorous sport activities for at least 3 months after the injury. Any recurrent dislocation and return to sports were assessed at 2-year follow-up. RESULTS: Of 109 patients, 90 were followed up for 2 years. The compliance rates were 60% to 72% among the groups (P = .54). The recurrence rate of dislocation was 28% in the 0-week group, 33% in the 3-week group, and 32% in the 6-week group (P = .88) according to the intention-to-treat analysis, and they were a respective 24%, 28%, and 27% according to the per-protocol analysis (P = .95). Based on the sport activity level, the recurrence rates for patients involved in contact sports (7/15, 47%) and those involved in noncontact sports (19/51, 37%) were significantly higher than for those not involved in sport activities (2/24, 8.3%) (P = .0076). Among the 3 groups, there were no significant differences in the recurrence rates. There was no significant difference in the rate of return to sports (P = .39). CONCLUSION: No difference in the recurrence rate was seen with the use of a shoulder motion restriction band after 3 weeks of immobilization in external rotation after an initial dislocation of the shoulder.
Authors: Gareth Davies; Daniel Yeomans; Zoe Tolkien; Irene A Kreis; Shelley Potter; Matthew D Gardiner; Abhilash Jain; James Henderson; Jane M Blazeby Journal: Trials Date: 2020-06-08 Impact factor: 2.279