MedPath

Superior Capsular Reconstruction: A registry study

Conditions
superior capsular reconstructions
kapselreconstructie
cuff scheur
schouder instabiliteit
shoulder
instability
rotator cuff
Registration Number
NL-OMON21377
Lead Sponsor
St. Antonius Ziekenhuis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
15
Inclusion Criteria

• Subjects that have consented to implantation of allograft tissue

• Adult patients (≥18 year)

Exclusion Criteria

Pre-Op exclusion criteria

• Pregnant or planning to become pregnant

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary outcome will be change in pain score (Numeric Rating Scale: 0-10) at 1 year after surgery. A decrease of 2 points in pain is considered to be a clinical relevant decrease. A decrease in pain is expected from 12 weeks on, although patients will not be fully functional and are still in their rehabilitation process until one year after surgery.
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath