Null 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…
ID
Bron
Verkorte titel
Aandoening
Radial head fractures, Mason 2, open reduction internal fixation, elbow
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
DASH score.
Achtergrond van het onderzoek
Fractures 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.
Doel van het onderzoek
Null 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.
Onderzoeksopzet
Postoperative follow-up:
3 months, 6 months, 1 year.
Onderzoeksproduct en/of interventie
This study will randomize between:
1. Direct open reduction and internal fixation;
2. Nonoperative treatment.
Publiek
Marjolein Mulders
Amsterdam 1100 DD
The Netherlands
+31628243430
m.a.mulders@amsterdamumc.nl
Wetenschappelijk
Marjolein Mulders
Amsterdam 1100 DD
The Netherlands
+31628243430
m.a.mulders@amsterdamumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3260 |
| NTR-old | NTR3413 |
| Ander register | ABR : 40714 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Samenvatting resultaten
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