I appreciate the opportunity to respond to the letter by Dr.DeSilva who raised questions regarding the follow-up of our study cohort. Anyone who has conducted clinical studies will recognize the difficulties in having study subjects fully compliant with a study protocol. Our study protocol was designed to assure that all data points were collected. Despite the rigorous attempt at follow-up of all subjects, some chose not to return. As stated in the paper, there were many reasons for loss of follow-up: our hand surgery program draws patients from a large geographic area;many of the patients chose to be followed locally after surgery; and quite a few of the study subjects had excellent early recovery of function and chose not to return. Nevertheless, we continued to track every patient who had consented to the study. These efforts included phone calls to the study subjects and structuring follow-up assessments as efficiently as possible to minimize study burden to the subjects.

While full follow-up of all subjects is important, it is equally crucial to assure that the data obtained from the available subjects are representative of the outcomes of the population. Given that there is no detectable systematic bias between the responders and non-responders in this study, we are quite confident that the data presented can be extrapolated to a larger population of patients undergoing volar locking plate fixation.

Threats to validity of a study must be considered by minimizing all controllable biases. In this series, we avoided selection bias by performing volar locking plating technique for consecutive patients presented with unstable distal radius fractures. The concept of equipoise whereby the surgeons do not have an innate preference for a particular technique can be applied in this study. Our systematic analysis on outcomes of distal radius fracture treatment(1) and the Cochrane Review have shown that the literature does not support the superiority of a particular technique for treating this injury. Therefore, for a patient with an unstable distal radius fracture, the choice of treatment technique is often based on the preference of the treating surgeon. It was ethical for us to perform the volar locking plating technique in this consecutive series of patients in an effort to avoid potential selection bias, which was prevalent in many prior studies. We have an extensive experience with distal radius fracture fixation and have used a variety of techniques to treat this injury. This database is extremely valuable in being able to determine outcomes associated with this new innovation.

This study showed that patients recovered functional outcomes rather quickly with this technique. From our data, it is apparent that the patients in this series reached close to maximum improvement at 6 months after surgery and the outcome improvement between 6 months to 1 year was rather modest. Therefore, to track outcomes for this group of patients beyond one year would have added additional burden to the study subjects without yielding helpful information.

It is important to note that early patient-rated functional outcomes cannot be equated with long term radiographic outcomes. As indicated in the paper, with long-term follow-up, we may detect radiographic arthrosis in patients with intra-articular fractures. Whether radiographic arthrosis correlates with longer term functional outcomes remains to be seen.

Soft tissue injuries associated with distal radius fractures have not been adequately studied. This is an interesting area for research, as surgeons have focused mainly on the quality of fracture reduction without considering whether the extent of soft tissue trauma may affect outcome. It will be interesting to develop an analytic scale to quantify the amount of soft tissue injury associated with distal radius fractures. It is quite possible that the extent of soft tissue injury may have a substantial effect on outcomes for patients with distal radius fractures. We are currently performing a study based on this specific study question, and we will be pleased to share the results with the JBJS readership in the near future.

I appreciate the opportunity to answer the thoughtful questions raised by Dr. DeSilva and I thank JBJS for permitting me to respond.

Reference:

1. Margaliot Z, Haase SC, Kotsis SV, Kim HM, Chung KC: A meta- analysis of outcomes of external fixation versus plate osteosynthesis for unstable distal radius fractures. The Journal of Hand Surgery 30A:1185-1201, 2005.

To The Editor:

In the recent article by Chung,et al.(1), the authors reported on what initially appears to be 161 patients who underwent open reduction and internal fixation of “inadequately reduced” distal radius fractures. However, the results are about a significantly fewer number of patients.

In fact, at one year follow-up, outcomes for hand function, range of motion, radiographic assessment, and the outcomes questionnaire used, were applied to 41, 40, 42, and 42 patients respectively. These numbers were derived from 87 patients who were actually enrolled in the study – not 161. So, the one year outcomes represented at best 48% of the enrolled subjects. Moreover, only 26% of the group (23 patients) provided data for all three data intervals over a one year period.

Thus, I find it interesting that the authors quote the excellent work by Kreder, et al. referring to “the tendency for trauma patients to be noncompliant” (2). While Kreder et al. state that “loss to follow up was a significant problem”, their patient follow up was much better than the study by Chung et al. In Kreder’s two studies on distal radius fractures evaluating separately displaced intra-articular distal radius fractures and those without joint incongruity (2,3), the follow up was 96% and 93% at six months, 83% and 78% at one year, and 75% and 66% at two year follow-up.

The non-uniform fracture mix (40% AO Type A, 9% AO Type B, and 51% AO Type C) makes it very difficult to understand what the absolute, or preferred, application of the volar plating system is. Most interesting is the authors’ comment, “While certain fracture patterns may be amenable to simpler techniques such as percutaneous pinning in this series, we treated all fracture patterns with the use of the volar locking plating systems to better understand the properties and outcomes of this new technology.” This comment alone is a departure from traditional patient management.

In conclusion, several questions arise. 1. How many distal radius fractures were treated by the authors by closed means, or by percutaneous pinning, or with external fixation, during the same period of time? 2. Who performed the reductions that turned out to be unsatisfactory: staff physicians, plastic surgery residents, emergency room physicians? 3. What was the time interval from injury to surgery? Could this be a factor in the soft tissue complications noted by the authors? 4. The standard that the JBJS has promoted since Doctor Cowell’s article in 1993 has been a two year follow-up minimum (4,5). Why was this standard waived?

The author did not receive any outside funding or grants in support of his research for or preparation of this work. Neither he nor a member of his immediate family received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the author, or a member of his immediate family, is affiliated or associated .

References:

1. Chung KC, Watt AJ, Kotsis SV, Margaliot Z, Haase SC, Kim HM. Treatment of unstable distal radial fractures with the volar locking plating system. J Bone Joint Surg Am 2006;88:2687-2694

2. Kreder HJ, Hanel DP, Agel J, McKee M, Schemitsch EH, Trumble TE, Stephen D. Indirect reduction and percutaneous fixation versus open reduction and internal fixation for displaced intra-articular fractures of the distal radius: a randomised, controlled trial. J Bone Joint Surg Br. 2005 Jun;87(6):829-36

3. Kreder HJ, Agel J, McKee M, Schemitsch EH, Stephen D, Hanel DP. A randomized, controlled trial of distal radius fractures with metaphyseal displacement but without joint incongruity: closed reduction and casting versus closed reduction, spanning external fixation, and optional percutaneous K-wires. J Orthop Trauma. 2006 Feb;20(2):115-21.

4. Cowell HR. Preparing manuscripts for publication in The Journal of Bone and Joint Surgery: responsibilities of authors and editors. A view from the editor of the American volume. J Bone Joint Surg. Am., Mar 1993; 75: 456 - 463.

5. JBJS. Instructions to authors. http://www2.ejbjs.org/misc/instrux.shtml Accessed 2007 Jan 23.

As indicated in our paper(1), the reason that consecutive patients received the volar locking plating system was to better understand the system so that we can better appreciate the outcomes associated with this form of fixation. Many volar-Barton type fractures in this series were fixed quite well by this device. But I do agree with Dr. Garg and colleagues that there are certain volar Barton fractures--particularly those with distal fracture fragments-- that may not be suitable for the fixed angle system because of the potential for penetration of the distal pegs into the radio-carpal joint. There are other systems available that have variable angle peg technology to insert the pegs more proximally under the subchondral bone.

With regard to comminuted intra-articular fractures, whether or not to use an external fixator depends on the amount of comminution. Because we have gained a great deal of experience with the VLPS, our indications for placing external fixators have narrowed substantially. But we will not hesitate to use an external fixator in conjunction with a volar locking plating system or K-wire fixation if the fracture pattern demands it.

When confronted with a distal radius fracture, a surgeon must consider alternative modes of treatment, based on the fracture type, patient characteristics, and the experience of the surgeon. No one technique or plating system is universally applicable for the wide variability in the distal radius fracture patterns. I appreciate the excellent points raised by our esteemed colleagues in India and the kind consideration of JBJS for allowing me to respond.

Reference:

1. Chung KC, Watt AJ, Kotsis SV, Margaliot Z, Haase SC, Kim HM. Treatment of unstable distal radial fractures with the volar locking plating system. J Bone Joint Surg Am. 2006;88:2687-2693.

To The Editor:

In the article, "Treatment of Unstable Distal Radial Fractures with the Volar Locking Plating system"(1), the indications described by the authors are very broad. In our opinion, the following subsets of unstable distal radius fractures should not be considered as applicable for use with this system.

1. Volar Barton fractures are very unstable and are not amenable to be treated with this fixed angle system because it does not compress or buttress the fragment adequately. We believe the volar Barton fracture should be treated with a standard volar buttress, straight or oblique plate.

2. In very comminuted fractures, there is no place for inserting the distal screws for this device. an external fixator is a much safer option.

The volar plate locking plate has a fixed angle . We suggest that this system can also be used as a reduction device to help acheive proper volar and radial inclination. In summary, this system is more useful if the volar, as well as the dorsal cortex, is disrupted and there is intact subchondral bone to place the locking screws distally. If possible, a preoperative CT scan is very much helpful in this setting.

The authors of this did not receive any outside funding or grants in support of their research for or preparation of this work. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.

Reference:

1. Chung KC, Watt AJ, Kotsis SV, Margaliot Z, Haase SC, Kim HM. Treatment of unstable distal radial fractures with the volar locking plating system. J Bone Joint Surg Am 2006;88:2687-2694.