Proximal Humeral Fractures, AO/OTA (2007) Group B2 and C2 Clinical Trial
— DELPHIOfficial title:
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
| Verified date | October 2022 |
| Source | Oslo University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 124 |
| Est. completion date | September 1, 2022 |
| Est. primary completion date | August 1, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 65 Years to 85 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Norway | Oslo University Hospital | Oslo |
| Lead Sponsor | Collaborator |
|---|---|
| Oslo University Hospital | Diakonhjemmet Hospital, Helse Forde, Sykehuset Asker og Baerum, Sykehuset i Vestfold HF, Sykehuset Ostfold, Sykehuset Telemark |
Norway,
Fjalestad T, Iversen P, Hole MØ, Smedsrud M, Madsen JE. Clinical investigation for displaced proximal humeral fractures in the elderly: a randomized study of two surgical treatments: reverse total prosthetic replacement versus angular stable plate Philos — View Citation
Fraser AN, Bjørdal J, Wagle TM, Karlberg AC, Lien OA, Eilertsen L, Mader K, Apold H, Larsen LB, Madsen JE, Fjalestad T. Reverse Shoulder Arthroplasty Is Superior to Plate Fixation at 2 Years for Displaced Proximal Humeral Fractures in the Elderly: A Multi — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 15D Quality of Life score | Follow-up will be at 3-6-12 months and 2-5 years. | 5 years | |
| Other | Health Economics | Follow-up will be at 3-6-12 months and 2-5 years. | 5 years | |
| Primary | Constant Shoulder Score | Follow-up will be at 3-6-12 months and 2-5 years. | 5 years | |
| Secondary | Oxford Shoulder score | Follow-up will be at 3-6-12 months and 2-5 years. | 5 years |