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


- candidate number12317
- NTR NumberNTR3413
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-mei-2012
- Secondary IDs40714 ABR
- Public TitleOperative vs. nonoperative treatment of Mason type 2 Radial Head Fractures: A multicenter randomized controlled trial.
- Scientific TitleOperative vs. nonoperative treatment of Mason type 2 Radial Head Fractures: A multicenter randomized controlled trial.
- ACRONYMRAMBO trial
- hypothesisNull hypothesis: Patients with a Broberg and Morrey modified Mason type 2 radial head fracture that are treated nonoperatively have the same outcomes in terms of DASH scores after 6 months as opposed to patients that are treated with open reduction and internal fixation.
- Healt Condition(s) or Problem(s) studiedInternal fixation, Diagnostic work-up, Radius, Open reduction, Radial head fractures
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2012
- planned closingdate1-okt-2014
- Target number of participants80
- InterventionsThis study will randomize between:
1. Direct open reduction and internal fixation;
2. Nonoperative treatment.
- Primary outcomeDASH score.
- Secondary outcome1. Oxford Elbow Score;
2. Mayo Elbow Performance Index.
- TimepointsPostoperative follow-up:
3 months, 6 months, 1 year.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES R.J.O. Muinck Keizer, de
- CONTACT for SCIENTIFIC QUERIES R.J.O. Muinck Keizer, de
- Sponsor/Initiator Academic Medical Center (AMC), Department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications1. Broberg MA, Morrey BF. Results of delayed excision of the radial head after fracture. J Bone Joint Surg Am 1986;68:669-674.
2. Broberg MA, Morrey BF. Results of treatment of fracture-dislocations of the elbow. Clin Orthop Relat Res 1987:109-119.
3. Calderon SA, Zurakowski D, Davis JS, Ring D. Quantitative Adjustment of the Influence of Depression on the Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire. Hand (N Y) 2009. doi:10.1007/s11552-009-9205-8
4. Chow SC LJ. Design and analysis of clinical trials: concepts and methodologies. New York: John Wiley & Sons; 1998.
5. Mason ML. Some observations on fractures of the head of the radius with a review of one hundred cases. Br J Surg 1954;42:123-132.
6. Rosenberger W LJ. Randomization in clinical trials: theory and practice. New York: Wiley-Interscience; 2002.
7. Zarattini G, Galli S, Marchese M, Mascio LD, Pazzaglia UE. The surgical treatment of isolated mason type 2 fractures of the radial head in adults: comparison between radial head resection and open reduction and internal fixation. J Orthop Trauma 26:229-235. doi:10.1097/BOT.0b013e318220a227
- Brief summaryFractures of the radial head are commonly classified according to the classification by Mason1 as modified by Broberg and Morrey. Nondisplaced or minimally displaced fractures are classified as Mason type 1 and are usually treated nonoperatively. Fractures with a gap of more than 2 mm or fractures that comprise more than 1/3 of the articular surface are defined as Mason type 2 fractures. Mason type 3 fractures are severely comminuted radial head fractures and are most commonly treated operatively. For displaced, isolated partial articular fractures (Mason type 2), the choice of treatment is subject to discussion, partially due to the absence of level 1 evidence. Previously, these fractures were treated nonoperatively; if treatment failed, radial head excision would be performed. Nowadays, the tendency lies towards open reduction and internal fixation of isolated displaced partial articular radial head fractures. In this multicenter prospective randomized trial, we will compare ORIF by means of screw fixation vs. nonoperative management in the treatment of Mason type two fractures of the radial head. The primary objective of this study is functional outcome measured by the Disabilities of Arm, Shoulder and Hand (DASH) Score in adult patients after one year. Secondary outcomes are Mayo Elbow Performance Index (MEPI) and Oxford Elbow Score (OES) as well as the level of pain measured by means of a Visual Analog Scale (VAS), Range of Motion (ROM), flexion arc and rotational arc. Complications such as arthrosis, subsequent or revision surgery, neurovascular compromise and infections will be recorded.
- Main changes (audit trail)
- RECORD2-mei-2012 - 13-feb-2013


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