The objective of this study is to conduct a randomized controlled trial to compare hemiarthroplasty with open reduction and internal fixation with an angle stable locking compression plate in the treatment of dislocated three- and four-part…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome parameter is speed of recovery of functional capacity of the
affected upper limb.
Secondary outcome
Secondary outcomes are: pain, patient satisfaction, functional outcome, quality
of life, radiographic evaluation and complications
Background summary
The optimal surgical management of three- and four-part proximal humeral
fractures in elderly osteoporotic patients remains controversial. Mostly used
techniques are hemiarthroplasty and angle stable locking compression
osteosynthesis. In literature there is no evidence available showing advantage
of angle stable locking compression plate osteosynthesis compared to
hemiarthroplasty regarding speed of recovery of functional capacity, pain,
patient satisfaction,functional outcome, quality of life, and complications.
Study objective
The objective of this study is to conduct a randomized controlled trial to
compare hemiarthroplasty with open reduction and internal fixation with an
angle stable locking compression plate in the treatment of dislocated three-
and four-part fractures of the proximal humerus in the elder population.
Primary outcome parameter is speed of recovery of functional capacity of the
effected upper limb. We hypothesize that hemiarthroplasty shows quicker
recovery of functional capacity. Secondary outcome parameters are pain,patient
satisfaction, functional outcome, quality of life, radiographic evaluation and
complications.
Study design
A prospective, non-blinded, multicentric randomized controlled trial will be
conducted to allocate patients to either hemiarthroplasty or open reduction
and internal fixation with angle stable locking compression plate
osteosynthesis to study speed of recovery of functional capacity and other
secondary outcomes.
Intervention
One group will be treated by hemiarthroplasty and the other group will be
treated by open reposition and internal fixation with a angle stable locking
compression plate.
Study burden and risks
The methods of treatment in this study are contemporary *common current
treatment* methods. There can be found two main risk factors. The first is the
possible negative effects of exposure to radiation when making a CT-scan.
Nevertheless, this is a common used and necessary investigation in
characterizing the fracture type and in choosing the forthcoming treatment
method. The second is the possibility of appearence complications after
operative treatment of three- and four- part fractures of the proximal humerus.
In literature, operative treatment is recommended and no significant difference
in number or gravity in the appearance of complications between treatment with
hemiarthroplasty or treatment with angle stable locking compression plate
osteosynthesis can be found. Furthermore, patients will be seen three times
during an outpatient clinic visit and will be asked twice to fill in a
questionnaire that will be send to their home address.
Postbus 30001
9700 RB Groningen
NL
Postbus 30001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
Patients to be included suffer from three- or four- part fracture of the proximal humerus according to the Neer classification with more than 5 mm dislocation in one of the fracture-planes and are aged above 60 years.
Exclusion criteria
Patients with a fracture existing more than 14 days, ASA IV-V, multitrauma (ISS>16), pathological fracture, previous surgery on the injured shoulder, severely deranged function caused by a previous disease, head-split proximal humerus fracture and unwillingness or inability to follow instruction are excluded.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL29934.042.09 |
OMON | NL-OMON23688 |