Arthroplasty in three- or four-part proximal humerus fracture: hemi or reverse?

Arthroplasty in three- or four-part proximal humerus fracture: hemi or reverse? Prospective multi-centre randomised clinical trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21570

Enrollment

Registered

2011-12-18

Start date

2010-07-01

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

proximal humerus fracture arthroplasty

Interventions

1. Aequalis fracture prosthesis

2. Aequalis reverse fracture prosthesis.

Eligibility

Inclusion criteria

Inclusion criteria: Patients of 65 years and above with an isolated 3- or 4-part (displaced) proximal humerus fracture who are candidates for primary shoulder arthroplasty. Included patients must have complete understanding of the Dutch language.

Exclusion criteria

Exclusion criteria: Primary exclusion criteria are age less than 65 and an ASA-score 4 or higher. Patients with a previous osteosynthesis of the shoulder, as well as a delay of more than 1 month will also be excluded. Patients who lack understanding of the Dutch language are excluded. Secondary exclusion criteria is a glenoid bone defect greater than 30% or more than 15 degrees of retroversion of the glenoid.

Design outcomes

Primary

Measure	Time frame
Constant shoulder score.	—

Secondary

Measure	Time frame
1. DASH score; 2. SF12; 3. VAS pain.	—

Contacts

Public ContactYde Engelsma

Medisch Centrum Alkmaar Wilhelminalaan 12

y.engelsma@mca.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)