Conservative management versus open reduction and internal fixation for mid-shaft clavicle fractures in adults - The Clavicle Trial: Study protocol for a multicentre randomized controlled trial

Background: Clavicle fractures account for around 4% of all fractures and up to 44% of fractures of the shoulder girdle. Fractures of the middle third (or mid-shaft) account for approximately 80% of all clavicle fractures. Management of this group of fractures is often challenging and the outcome can be unsatisfactory. In particular it is not clear whether surgery produces better outcomes than non-surgical management. Currently there is much variation in the use of surgery and a lack of good quality evidence to inform our decision.Methods/Design: We aim to undertake a multicentre randomised controlled trial evaluating the effectiveness and safety of conservative management versus open reduction and internal fixation for displaced mid-shaft clavicle fractures in adults. Surgical treatment will be performed using the Acumed clavicle fixation system. Conservative management will consist of immobilisation in a sling at the side in internal rotation for 6 weeks or until clinical or radiological union. We aim to recruit 300 patients. These patients will be followed-up for at least 9 months. The primary endpoint will be the rate of non-union at 3 months following treatment. Secondary endpoints will be limb function measured using the Constant-Murley Score and the Disabilities of the Arm, Shoulder and Hand (DASH) Score at 3 and 9 months post-operatively.Discussion: This article presents the protocol for a multicentre randomised controlled trial. It gives extensive details of, and the basis for, the chosen methods, and describes the key measures taken to avoid bias and to ensure validity.Trial Registration: United Kingdom Clinical Research Network ID: 8665. The date of registration of the trial is 07/09/2006. The date the first patient was recruited is 18/12/2007. © 2011 Longo et al; licensee BioMed Central Ltd

Symphyseal fixation in open book injuries cannot fully compensate anterior SI joint injury-A biomechanical study in a two-leg alternating load model.

In open book injuries type Tile B1.1 or B1.2 also classified as APC II (anteroposterior compression), it remains controversial, if a fixation of the anterior ring provides sufficient stability or a fixation of the posterior ring should be included. Therefore the relative motion at the sacroiliac joint was quantified in a two-leg alternating load biomechanical pelvis model in the intact, the injured and the restored pelvis.Fresh-frozen intact (I) pelvises (n = 6) were subjected to a non-destructive cyclic test under sinosuidal axial two-leg alternating load with progressively increasing amplitude. Afterwards an open book injury (J) including the anterior ligament complex of the left sacroiliac joint, the sacrospinal and sacrotuberal ligaments (Tile B1.1) was created and the specimens were retested. Finally, the symphysis was stabilized with a modular fixation system (1-, 2- or 4-rod configuration) (R) and specimens were cyclically retested. Relative motion at the sacroiliac joint was captured at both sacroiliac joints by motion tracking system at two load levels of 170 N and 340 N during all tests.Relative sacroiliac joint movements at both load levels were significantly higher in the J-state compared to the I-state, excluding superoinferior translational movement. With exception of the anteroposterior translational movement at 340N, the relative sacroiliac joint movements after each of the three reconstructions (1-, 2-, 4-rod fixation) were significantly smaller compared to the J-state and did not differ significantly to the I-state, but stayed above the values of the latter. Relative movements did not differ significantly in a direct comparison between the 1-rod, 2-rod and 4-rod fixations.Symphyseal locked plating significantly reduces relative movement of the sacroiliac joint in open book injuries type Tile B1.1 or B1.2 (APC II) but cannot fully restore the situation of the intact sacroiliac joint