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

Abstract

BackgroundClavicle 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/DesignWe 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.DiscussionThis 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 RegistrationUnited 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.

Scaffolds in Tendon Tissue Engineering

“…Valentin et al [ 88 ] examined the host-tissue morphologic response to five commercially available extracellular matrix-derived biological scaffolds (GraftJacket, Restore, CuffPatch, TissueMend, Permacol) used for orthopaedic soft-tissue repair in a rodent model. Each device elicited a distinct morphologic response that differed with respect to cellularity, vascularity, the presence of multinucleated giant cells, and organization of the remodelled tissue [ 117 – 129 ]. More rapidly degraded devices such as Restore and autologous tissue showed the greatest amount of cellular infiltration, especially at the early time points [ 78 , 130 – 146 ].…”

Intramedulläre Stabilisation von dislozierten Klavikulaschaftfrakturen bei Schwerarbeitern und komplexen Frakturen

“…Sowohl bei konservativ als auch operativ therapierter DKSF werden frühfunktionelle, aber auch immobilisierende Nachbehandlungsschemata publiziert. Die frühfunktionelle Nachbehandlung umfasst schmerzabhängige Bewegungen mit der Belastungsaufnahme in Abhängigkeit von der klinischen und/oder radiologischen Frakturkonsolidierung [16,18,23], während andere eine wochenlange Ruhigstellung empfehlen, bevor mit passiv-assistierten und aktiven Bewegungsübungen begonnen wird [21,31]. [32].…”

“…Tag nach der OP zu ermöglichen und den Schmerz am 3 Tag nach der OP signifikant (p < 0,001) zu verringern[16]. In der vorliegenden Arbeit konnten wir zeigen, dass eine frühfunktionelle Mobilisation des Schultergelenks nach IMS einer DKSF mit und ohne PT eine deutlich kürzere AUFD zur Folge hatte, als die in vielen anderen Studien publizierten Ergebnisse, die in ihren Nachbehandlungsschemata eine längere Ruhigstellung vorsahen[21,31]. In diesen beiden Gruppen war die Komplexität der DKSF und die berufliche Arbeitsbelastung der Patienten vergleichbar verteilt.…”

The Foundation of the British Elbow and Shoulder Society (BESS)

“…Perhaps the most exciting BESS development has been the creation of a BESS Research Committee in 2008 that has led the way with high-quality research, particularly multicentre clinical trials. Some have already been published in high impact journals and influenced policy (NICE guidance) and others are on-going: The PROximal Humeral Fracture – Evaluation by Randomisation (PROFHER) Trial 3,4 The United Kingdom Rotator Cuff Trial (UKUFF): Trial of arthroscopic vs open rotator cuff repair 5 Can Shoulder Arthroscopy Work (CSAW): Placebo controlled trial of arthroscopic subacromial decompression 6 The Clavicle Trial: Surgical versus nonsurgical treatment of displaced mid-shaft clavicular fractures 7 The United Kingdom Frozen Shoulder Trial (UKFROST) 8 The recently completed James Lind Alliance Priority Setting Partnership on surgery for shoulder pain has identified its top ten research priorities, which will become the focus of future research for BESS 9 …”

“…The Clavicle Trial: Surgical versus nonsurgical treatment of displaced mid-shaft clavicular fractures 7…”