Electronic Letters to:

Trauma: J.-W. Shen, P.-J. Tong, and H.-B. Qu A three-dimensional reconstruction plate for displaced midshaft fractures of the clavicle J Bone Joint Surg Br 2008; 90-B: 1495-1498 [Abstract] [Full text] [PDF]

eLetters: Submit a response to this article

Electronic letters published:

Authors' reply:

Jin-Wen Shen, Pei-Jian Tong, Hang-Bo Qu   (18 December 2008)

A three-dimensional reconstruction plate for displaced midshaft fractures of the clavicle

Amit Kumar, A. Kumar, P.Monga, D Sandher   (21 November 2008)

Authors' reply: 18 December 2008
Jin-Wen Shen, Orthopaedic Surgeon Dept of Orthopedic & Traumatic Surgery, Zhejiang Province TCM Hospital, Hangzhou, China, Pei-Jian Tong, Hang-Bo Qu Send letter to journal: Re: Authors' reply: shenjw100{at}163.com Jin-Wen Shen, et al.	Sir, We thank A. Kumar et al for their interest and constructive comments on our paper. In the following, we have addressed all comments on a point-by-point basis. We hope that the answers are satisfactory. There had been estimate effects as NNTs (numbers needed to treat) in our study. During the preliminary study, we found the difference between the two groups in the risk ratios of complication was higher than 10%. Moreover, the ratio in the 3D group was lower than 5%, confirming α=0.05 as well as 1-β=0.80, we approximately calculated the total sample size as 150. Aetiological factors that contribute to the development of nonunion include open fracture, associated polytrauma, refracture, initial fracture displacement, comminution, shortening, older age and an inadequate period of immobilisation.1-3 It is important to identify risk factors associated with the nonunion of clavicular fractures; therefore, there will be further prospective series to define epidemiological aspects of these subgroups. In our cases, a completely displaced midshaft fracture of the clavicle was defined as no cortical contact between the fragments. Historically, treatment and follow-up after clavicular fractures have been focused on nonunions. However, clavicular nonunion has not been clearly defined in the literature so far. Thus, in 1986, the American Food and Drug Administration (FDA) defined nonunion as being ’established when a minimum of nine months has elapsed since injury and the fracture shows no visible progressive signs of healing for three months’. However, these criteria cannot be applied to every fracture.4 Many authors agree that nonunion is present when consolidation does not happen four to six months after the injury.5,6 So a diagnosis of delayed union can be made if healing does not occur 16 weeks after surgery; in addition, all patients with delayed union had some degree of remaining symptoms. In our study, evaluation of the complication consisted of the rate of occurrence of delayed union (defined as non presence of bridging callus in one of the two cortices as seen on anteroposterior view or 45° cephalic tilt view after more than 16 weeks, including physical examination with local signs and symptoms of later symptomatic patients) and later symptomatic patients (defined as physical examination with local signs and symptoms including two or more of the following four symptoms: pain at rest, pain during activity, strength reduction, shoulder elevation<120º) at more than 16 weeks after surgery. These variables were used after dichotomisation (e.g. pain at rest = no/yes). Jin-Wen Shen, MD, Orthopaedic Surgeon, Pei-Jian Tong, MD, PhD, Orthopaedic Surgeon, Professor, Hang-Bo Qu, MD, Orthopaedic Surgeon, Department of Orthopedic and Traumatic Surgery, Zhejiang Province TCM Hospital and Zhejiang TCM University Hospital, Hangzhou, China. 1. Jupiter JB, Leffert RD. Non-union of the clavicle: associated complications and surgical management. J Bone Joint Surg [Am] 1987;69-A:753–60. 2. Marti RK, Nolte PA, Kerkhoffs GM, Besselaar PP, Schaap GR. Operative treatment of mid-shaft clavicular non-union. Int Orthop 2003;27:131–5. 3. Robinson CM, Court-Brown CM, McQueen MM, Wakefield AE. Estimating the risk of nonunion following nonoperative treatment of a clavicular fracture. J Bone Joint Surg [Am] 2004;86-A:1359–65. 4. La Velle DG. Delayed union and nonunion of fractures. In: Canale ST. Campbell’s Operative Orthopaedics. Vol. 3, 10th ed. Philadelphia: Mosby Elsevier, 2003:3125–65. 5. Jeray KJ. Acute midshaft clavicular fracture. J Am Acad Orthop Surg 2007;15:239-48. 6. Manske DJ, Szabo RM. The operative treatment of mid-shaft clavicular non-unions. J Bone Joint Surg [Am] 1985;67-A:1367–71.
A three-dimensional reconstruction plate for displaced midshaft fractures of the clavicle 21 November 2008
Amit Kumar, Senior SHO Orthopaedics Central Manchester and Manchester Children’s University NHS Trust, Manchester Royal Infirmary, A. Kumar, P.Monga, D Sandher Send letter to journal: Re: A three-dimensional reconstruction plate for displaced midshaft fractures of the clavicle mrakumar78{at}gmail.com Amit Kumar, et al.	Sir, We read this paper with interest and we would like to congratulate the authors for conducting this randomised study. The authors have included 133 patients (67 to 3D plate group and 66 to superior plate group) with displaced clavicle fractures. There was a significant difference (p<0.05) in the superior plate group with a higher rate of delayed union and symptomatic patients compared with the 3D plate group1. We would ask the authors to comment on how they agreed on the number of patients in each group. There has been no indication of formal calculation of “numbers needed to treat” in the manuscript and we wonder if this was an inadvertent omission. It is common practice to contemplate internal fixation in the case of shortening of more than 2 cm due to the risk of non union.1 The authors state that their inclusion criteria are those mid clavicle fractures with complete displacement. This could be a significant confounding factor and could we please request the authors to clarify the proportion of patients in each group who had severe displacement or shortening, as the difference in the outcome (in their study) could be related to the way this particular subset of patients got allocated in either group. Additionally, the conclusions of the study are based on delayed union being the primary outcome measure. Although there is no doubt about this being a significant consideration in choosing treatment options, we would appreciate information regarding non union rates in their treatment groups as we regard this as a more important outcome measure. Finally, we would like them to also state the symptoms experienced by those patients in the 3D plate group, though less than the superior group. We await the authors' clarification on these key issues prior to changing our practice based on this randomised study. A. Kumar, Senior SHO Orthopaedics, P. Monga, D. Sandher Central Manchester and Manchester Children’s University NHS Trust, Manchester Royal Infirmary, Manchester, UK. 1. Crenshaw AH Jr, Perez EA. Fractures of the Shoulder, Arm and Forearm. In: Canale & Beaty. Campbell’s Operative Orthopaedics. Vol. 3, 11th ed. Philadelphia: Mosby Elsevier, 2008:3371.