Oslo University Hospital
Oslo, Norway
NCT Number: NCT01737060
To investigate the assumption that reversed shoulder prosthetic replacement will give a better functional outcome compared to open reduction and internal fixation with an angular stable plate in displaced proximal humeral fractures. Short name: The DelPhi trial.
Looking for future studies?
Notify Me65 year–85 year
All sexes
Interventional
Not applicable
Oslo, Norway
Reversed total shoulder artroplasty (RTSA) equals Delta Xtend reversed total shoulder prosthesis.
Angular stable plate means Proximal humerus plate (Philos)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patient admitted in hospital with a displaced three- or four part proximal humerus fracture of OTA / AO group 11-B2 or 11-C2 (displaced fracture of extra-articular or articular, bifocal type). The subgroups -.1, -.2 and -.3 will be included for both B2 and C2 groups, provided severe displacement: This is defined as a mal-position of at least 45º of angular deviation in valgus or 30º in varus in true frontal projection, regardless of whether the fracture is impacted or not, or less than 50% contact between humeral head and the metaphyseal part of the shaft. The greater or lesser tubercle displaced at least 10 mm.
Exclusion criteria
Patient younger than 65 years or older than 85 years, previous history of injury or illness of the injured shoulder, injuries of other parts of the humerus or the contra-lateral upper extremity, alcohol- or drug abuse, dementia, neurological diseases, or severe cardiovascular or lung diseases that would contraindicate surgery. Patients have to understand the Norwegian language and be compliant to rehabilitation and follow-ups.
Other names: Delta Xtend shoulder proshesis
Time frame: 5 years
Follow-up will be at 3-6-12 months and 2-5 years.
Time frame: 5 years
Follow-up will be at 3-6-12 months and 2-5 years.
Time frame: 5 years
Follow-up will be at 3-6-12 months and 2-5 years.
Time frame: 5 years
Follow-up will be at 3-6-12 months and 2-5 years.
Oslo University Hospital
Other
Clinical Investigation for Fractures of the Proximal Humerus in Elderly Patients. A Randomized Study of Two Surgical Treatments: Reverse Total Shoulder Arthroplasty Versus Angular Stable Device Philos
Acronym: DELPHI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04928664
Fractures, Bone, Shoulder Fractures
Hong Kong
View Trial DetailsNCT05128500
Arthritis, Arthritis, Psoriatic
Hanover, Germany
View Trial DetailsNCT05215613
Diaphyseal Fracture, Fractures, Bone
Bologna, Italy
View Trial DetailsNCT05302089
Fractures, Bone, Shoulder Fractures
Køge, Denmark
View Trial Details