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Superior capsular reconstruction of irreparable degenerative rotator cuff tears of the shoulder: A multicenter, comparative, prospective, observational follow-up study

Recruiting
Conditions
Degenerative rotator cuff tear of the shoulder
Registration Number
NL-OMON26842
Lead Sponsor
VieCuri Fonds wetenschap en innovatie
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
40
Inclusion Criteria

Inclusion criteria for participation in this study are:
- Age = 40 years
- Patiënts with a symptomatic, irreparable degenerative rotator cuff tear, who are scheduled for arthroscopic superior capsular reconstruction rotator cuff tear scheduled for arthroscopic superior capsular reconstruction
- Patients who provided written informed consent

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- reumatoid arthritis
- inability to understand Dutch
- neurologic impairment influencing functioning affected limb

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary outcome measurement is functioning, measured with the Constant-Murley score (CMS)
Secondary Outcome Measures
NameTimeMethod
Secondary outcomes are: Functional limitations of arm, shoulder, hand in daily activities (measured by DASH); quality of life (measured with SF-12); pain (measured with NRS scale); Patient satisfaction (measured with NRS scale and 3 anchor questions using a Likert scale about improvement in pain relief, functioning, and recovery of symptoms); Acromiohumeral distance in mm(determined by means of X-ray); tears of the graft (determined based on MRI); presence of frosen shoulder (determined by clinical examination); occurance of (serious) adverse events
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