Compare hemi-arthroplasty with reverse arthroplasty in the treatment for displaced three- or four-part proximal humerus fractures
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Constant and DASH shoulder scores, ROM and VAS-pain.
Secondary outcome
Secondary parameters are complications and revision rate
Background summary
The ideal sequel in the treatment of displaced three and four part proximal
humerus fractures is still undefined. Hemi-arthroplasty is a reliable treatment
for pain reduction, however generally with a poor range of motion. Without the
necessity of an adequate cuff and vascularised tubercula reverse shoulder
arthroplasty can possibly provide a better functional outcome with the same
pain reduction.
Study objective
Compare hemi-arthroplasty with reverse arthroplasty in the treatment for
displaced three- or four-part proximal humerus fractures
Study design
Prospective randomized clinical trial
Intervention
Operative treatment by either Aequalis fracture prosthesis or Aequalis reverse
fracture prosthesis.
Study burden and risks
The general operative risks are equal in both groups. The complication risk, as
infection, instability en neuralpraxia, is comparable. Potential benefits in
the reverse group is a greater range of motion with equal pain reduction.
The number of visits is equal compared with standard procedure, however X-rays
and questionnaires will be taken more regularly.
Wilhelminalaan 12
Alkmaar 1815 JD
NL
Wilhelminalaan 12
Alkmaar 1815 JD
NL
Listed location countries
Age
Inclusion criteria
Patients of 65 years and above with a three or four part proximal humerus fracture, ASA 1-3 and within one month after the trauma.
Exclusion criteria
patients younger than 65 years, ASA-4 and a delay of moren than one month
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26142.094.09 |