Operative vs. nonoperative treatment of Mason type 2 Radial Head Fractures: A multicenter randomized controlled trial.
- Conditions
- Radial head fractures, Mason 2, open reduction internal fixation, elbow
- Registration Number
- NL-OMON27653
- Lead Sponsor
- Trauma Unit, Department of Surgery, Academic Medical Center, Amsterdam
- Brief Summary
1. Broberg MA, Morrey BF. Results of delayed excision of the radial head after fracture. J Bone Joint Surg Am 1986;68:669-674. <br> 2. Broberg MA, Morrey BF. Results of treatment of fracture-dislocations of the elbow. Clin Orthop Relat Res 1987:109-119. <br> 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<br> 4. Chow SC LJ. Design and analysis of clinical trials: concepts and methodologies. New York: John Wiley & Sons; 1998.<br> 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. <br> 6. Rosenberger W LJ. Randomization in clinical trials: theory and practice. New York: Wiley-Interscience; 2002.<br> 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
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;
1. Multiple Other Fractures;
2. Open fracture;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DASH score.
- Secondary Outcome Measures
Name Time Method 1. Oxford Elbow Score;<br /><br>2. Mayo Elbow Performance Index.