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Clinical, functional and psychosocial outcome of reverse shoulder arthroplasty - a prospective randomized comparison of two types of prostheses after traumatic fracture of the proximal humerus

Clinical, functional and psychosocial outcome of reverse shoulder arthroplasty - a prospective randomized comparison of two types of prostheses after traumatic fracture of the proximal humerus - CEUS #Delta

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00011581
Enrollment
60
Registered
2017-01-18
Start date
2017-01-12
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

S42.21 M19.91

Interventions

Group 1: Patients with RSA (reverse shoulder arthroplasty) after traumatic injury - model 'fracture prothesis' (with cavity for bone graft) Group 2: Patients with RSA (reverse shoulder arthroplasty) a

Sponsors

Zentrum für Orthopädie, Unfallchirurgie und Paraplegiologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with multifragmentary fracutres of the proximal humerus and indication of RSA. Patients with rotator cuff arthropathy and indication of planned RSA.

Exclusion criteria

Exclusion criteria: - known intolerance for SonoVue - severe heart failure (NYHA III/IV) - myocardial infarction within the last 14 days - severe respiratory diseases - pregnancy and breastfeeding - age under 18 years

Design outcomes

Primary

MeasureTime frame
Shoulder function: Constant-Murley-, ASES-, DASH-Score, Simple Shoulder Test; Psychosocial outcome: SF-12; Pain: visual analogue scale; radiological outcome: x-ray; 6 and 24 months postoperatively

Secondary

MeasureTime frame
Development of the perfusion in deltoid muscle tissue, assessed with contrast-enhanced ultrasound; 6 and 24 months postoperatively

Countries

Germany

Contacts

Public ContactChristian Alexander Fischer

Universität Heidelberg, Zentrum für Orthopädie, Unfallchirurgie und Paraplegiologie

christian.fischer@med.uni-heidelberg.de062215635366

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026