Skip to content

A Randomised Controlled Trial of Nonoperative Treatment versus Open Reduction and Internal Fixation for Mason type-II Fractures Of the Radial Head

A Randomised Controlled Trial of Nonoperative Treatment versus Open Reduction and Internal Fixation for Mason type-II Fractures Of the Radial Head - Rambo

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41363
Enrollment
80
Registered
2012-02-20
Start date
2012-09-03
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fracture of the head of the laterale bone of the forearm radial head fractrure

Interventions

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 a

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
The main study parameter is the change in DASH from baseline to endpoint (12 months later), in both groups.

Secondary

MeasureTime frame
The secundary study parameter is the change in OES and MEPI from baseline to endpoint (12 months later), in both groups.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)