NCT03739749

Arthroscopic Superior Capsular Reconstruction - Study of Different Types of Grafts

Arthroscopic Superior Capsular Reconstruction - Multicentric Prospective Comparative Study of Different Types of Grafts

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hospital de Egas Moniz · Academic / Other
• Sex: All
• Age: 40 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Multicentric prospective clinical and radiological comparative study of consecutive patients with irreparable rotator cuff tears to test the hypothesis that there are significant differences in the improvement of the clinical and imaging outcomes of arthroscopic superior capsular reconstruction (ASCR) when a different type of graft is used.

Detailed description

Patients with irreparable rotator cuff tears who meet the eligibility criteria will be enrolled in the study and undergo arthroscopic superior capsular reconstruction using one of the following types of graft: fascia lata autograft, fascia lata allograft, Achilles tendon allograft, bovine pericardium xenograft, swine dermal xenograft, or collagen graft. All patients will be assessed clinically, radiologically and with an MRI preoperatively and at the 6-months and at the 2-years postoperative evaluations. The range of motion (ROM), shoulder abduction strength, Constant (CS), simple shoulder test (SST) and subjective shoulder value (SSV) scores will be compared from preoperative to 6 months postoperative; from 6 months postoperative to 2 years postoperative (paired-samples t-test, two-tailed) in each group (allotment to groups is performed according to the type of graft used: fascia lata autograft, fascia lata allograft, Achilles tendon allograft, bovine pericardium xenograft, swine dermal xenograft, or collagen graft). The differences in ROM, shoulder abduction strength, CS, SST and SSV scores from preoperative to 6 months postoperative and from 6 months postoperative to 2 years postoperative will be compared between groups. All continuous variables will be compared between the group of patients with graft tears and the group without graft tears (Mann-Whitney U test). All categorical variables and outcome results will be compared between groups (Fisher's exact test). A significant difference will be defined as P\<0.05.

Conditions

• Rotator Cuff Tear
• Graft Complication

Interventions

Type	Name	Description
PROCEDURE	Arthroscopic superior capsular reconstruction	The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft

Timeline

• Start date: 2018-10-30
• Primary completion: 2022-10-30
• Completion: 2022-10-30
• First posted: 2018-11-14
• Last updated: 2023-02-28

Locations

1 site across 1 country: Portugal