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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26842

Enrollment

Registered

2019-04-18

Start date

2018-05-22

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative rotator cuff tear of the shoulder

Interventions

Arthroscopic superior capsular reconstruction by means of a porcine graft or human allograft.

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary outcome measurement is functioning, measured with the Constant-Murley score (CMS)	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactVivian Bruls

VieCuri Venlo

vbruls@viecuri.nl0032773205129

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)