The primary objective of this study is to compare the DASH (Disabilities of the Arm, Shoulder, and Hand) after conservative treatment versus ORIF in adult patients who sustained a Mason type-II fracture of the radial head. Secondary aims are to…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the change in DASH from baseline to endpoint (12
months later), in both groups.
Secondary outcome
The secundary study parameter is the change in OES and MEPI from baseline to
endpoint (12 months later), in both groups.
Background summary
Displaced partial articular fractures of the radial head are classified as
Mason type-II fractures. Open reduction and internal fixation remains a popular
treatment for isolated, stable displaced partial fractures of the radial head,
while there is no Level I or II evidence for optimal management of these
fractures. We will compare ORIF vs. nonoperative management in the treatment of
isolated, stable displaced partial fractures of the radial head.
Study objective
The primary objective of this study is to compare the DASH (Disabilities of the
Arm, Shoulder, and Hand) after conservative treatment versus ORIF in adult
patients who sustained a Mason type-II fracture of the radial head. Secondary
aims are to examine the effect of conservative treatment versus ORIF on
functional outcome (Mayo Elbow Performance Index (MEPI) and Oxford elbow scores
(OES), the level of pain (Visual Analog Scale (VAS)), ROM (flexion arc and
rotational arc), the rate of secondary interventions and complications.
Study design
Randomized controlled trial
Intervention
Patients that are assigned to non-operative management will get a sling for
comfort and are instructed to start active and active-assisted range of motion
exercises the same day. Patients that are assigned to ORIF will be treated by
screw fixation of the displaced partial articular fracture fragment. Patients
in both groups have the possibility to train under physical therapist guidance
according to study protocols.
Study burden and risks
Based upon current scientific literature, there is no clear preference for one
of the two treatments that patients can be assigned to in this study. Both
forms of treatment are regularly applied for these fractures in each of the
participating institutions and all surgeons participating in this study are
familiar with nonoperative and operative management of radial head fractures.
Patients will be exposed to radiation from radiographs. However, this exposure
is part of routine clinical care and represents no increased risk. There are no
extra radiographs taken as part of this study. The risks and discomfort of
participating in this study do not exceed those of standard treatment for this
condition.
Meibergdreef 9
Amsterdam Zuidoost 1105 AZ
NL
Meibergdreef 9
Amsterdam Zuidoost 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Age 18 years or older.
A maximum of 10 days after the trauma.
Fracture fragment size estimated at least 30% of the articular surface.
At least 2 millimeters step of the articular surface on at least one radiographic view.
Fracture amenable to screw fixation.
Provision of informed consent by patient
Exclusion criteria
Associated fracture or dislocation of the elbow or forearm.
Polytraumatized patients.
Cognitive deficits (closed head injury, coma, etc.) that prevent participation in rehabilitation.
History of operations or fractures of the involved elbow
Patients not amenable for operative treatment and/or general anaesthesia.
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 | NL38903.008.11 |