Operative vs. nonoperative treatment of Mason type 2 Radial Head Fractures: A multicenter randomized controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27653

Enrollment

Registered

2012-05-02

Start date

2012-09-01

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

Radial head fractures, Mason 2, open reduction internal fixation, elbow

Interventions

This study will randomize between: 1. Direct open reduction and internal fixation

2. Nonoperative treatment.

Eligibility

Inclusion criteria

Inclusion criteria: 1. 18 years of age; 2. Radial Head Fracture Broberg and Morrey modified Mason 2 = a two part fracture with >30% of the articular surface involved, and a >2mm displacement in any direction; 3. Diagnosis based on an AP and Lateral X-ray (with additional Greenspan view if necessary); 4. Fracture suited for screw fixation; 5. Treatment possible <10 days after date of injury.

Exclusion criteria

Exclusion criteria: 1. Multiple Other Fractures; 2. Open fracture; 3. Radial head fracture as part of an elbow dislocation; 4. A nondisplaced or comminuted fracture (Mason1 or 3); 5. Previous ipsilateral olecranon/distal humerus/radial head fracture; 6. Suspected osteolytic malignancy.

Design outcomes

Primary

Measure	Time frame
DASH score.	—

Secondary

Measure	Time frame
1. Oxford Elbow Score; 2. Mayo Elbow Performance Index.	—

Contacts

Public ContactMarjolein Mulders

Academisch Medisch Centrum

m.a.mulders@amsterdamumc.nl+31628243430

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)