Arthroscopic Superior Capsular Reconstruction - Study of Different Types of Grafts

Hospital de Egas Moniz

Status: Withdrawn

Conditions: Rotator Cuff Tear; Graft Complication

Treatments: Procedure: Arthroscopic superior capsular reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT03739749

01-2018-10HSFX

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 40 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Rotator cuff tear arthropathy, Hamada stage 1 or 2
• Complete rotator cuff tendon tear involving one or more tendons, with a Patte stage 3 tendon retraction on the preoperative magnetic resonance imaging

Exclusion criteria

• Rotator cuff tear arthropathy, Hamada stage 3 or 4
• Complete rotator cuff tendon tear involving one or more tendons, with Patte stage 1 or 2 tendon retraction on the preoperative magnetic resonance imaging
• Proximal humerus fracture
• Acute shoulder dislocation (in the previous 8 weeks)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 6 patient groups

Fascia lata autograft

Active Comparator group

Description:

Arthroscopic superior capsular reconstruction using a fascia lata autograft

Treatment:

Procedure: Arthroscopic superior capsular reconstruction

Fascia lata allograft

Active Comparator group

Description:

Arthroscopic superior capsular reconstruction using a fascia lata allograft

Treatment:

Procedure: Arthroscopic superior capsular reconstruction

Achilles tendon allograft

Active Comparator group

Description:

Arthroscopic superior capsular reconstruction using an achilles tendon allograft

Treatment:

Procedure: Arthroscopic superior capsular reconstruction

Bovine pericardium allograft

Active Comparator group

Description:

Arthroscopic superior capsular reconstruction using a bovine pericardium allograft

Treatment:

Procedure: Arthroscopic superior capsular reconstruction

Swine dermal xenograft

Active Comparator group

Description:

Arthroscopic superior capsular reconstruction using a swine dermal xenograft

Treatment:

Procedure: Arthroscopic superior capsular reconstruction

Collagen allograft

Active Comparator group

Description:

Arthroscopic superior capsular reconstruction using a collagen allograft

Treatment:

Procedure: Arthroscopic superior capsular reconstruction