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JBJS welcomes reader comments on published articles. Letters to the Editor are reviewed by JBJS editors but are not peer-reviewed. To submit your letter, please follow the "submit a response" link that appears in the content box at the upper right of the full text of the article.
Letters to the Editor to:
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- Scientific Articles:
the Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) Investigators
- Randomized Trial of Reamed and Unreamed Intramedullary Nailing of Tibial Shaft Fractures
J Bone Joint Surg Am 2008; 90: 2567-2578
[Abstract]
[Full text]
[PDF]
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Electronic letters published:
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The SPRINT investigators respond to Drs. Sarmiento and Latta
- Mohit Bhandari, MD, Paul Tornetta, III, MD; Marc Swiontkowski, MD; Emil Schemitsch, MD; Dave Sanders, MD; Stephen Walter, PhD; Gordon Guyatt, MD
(20 January 2009)
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Important Information Missing
- Augusto Sarmiento, MD, Loren L.Latta, PhD
(20 January 2009)
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The SPRINT investigators respond to Drs. Sarmiento and Latta |
20 January 2009 |
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Mohit Bhandari, MD Department of Clinical Epidemiology and Biostatistics, McMaster University, Paul Tornetta, III, MD; Marc Swiontkowski, MD; Emil Schemitsch, MD; Dave Sanders, MD; Stephen Walter, PhD; Gordon Guyatt, MD
Send letter to journal:
Re: The SPRINT investigators respond to Drs. Sarmiento and Latta
bhandam{at}mcmaster.ca Mohit Bhandari, MD, et al.
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We read with interest the letter from Drs Sarmiento and Latta in
response to our recently published multinational S.P.R.I.N.T. trial
comparing reamed versus non-reamed tibial nail insertion in patients with
closed and open tibial shaft fractures (1). They raised concerns about
omissions in our publication, including the following: 1) no infection
rates presented for all patients, 2) lack of radiographic assessments on
fracture healing times, x-ray shortening, and malunions and 3) lack of
reporting of knee pain.
The S.P.R.I.N.T. primary outcome, re-operation at 12 months was a
composite including bone grafts, implant exchanges, and dynamizations in
patients post intramedullary nail insertion and operations for infections
and fasciotomies (the latter two irrespective of the fracture gap).
Infections in both open and closed fractures were presented in tables 3
and 4 of the publication. We focused on only those infections that
required an operative procedure.
While radiographic assessments of shortening and malunion and time to
healing are traditionally important, they are less important to patients
than are reoperations, function, and pain. Our article focused on what we
believe is the most important issue in tibial fracture management: the
need for a re-operation. Tables 3 and 4 provide details about the types of
re-operations in response to non-unions.
Drs Sarmiento and Latta raised greatest concern with our omission of
knee pain and related functional issues – these issues are indeed
important. S.P.R.I.N.T. evaluated patient function at regular intervals up
to 12 months after surgery using the Short Form 36, the Short
Musculoskeletal Functional Assessment (SMFA), the Health Utilities Index
(HUI) and a focused Knee Pain Questionnaire. We will provide functional
and knee pain outcomes in a separate publication. As we stated in the
manuscript, our JBJS publication presented only our primary outcome (i.e.
re-operation rate) findings. We further referred readers to our trial
registration and our previously published [S.P.R.I.N.T.] protocol paper1
in the first paragraph of the Methods section.
Reference
1. SPRINT Investigators, Bhandari M, Guyatt G, Tornetta P 3rd,
Schemitsch E, Swiontkowski M, Sanders D, Walter SD. Study to prospectively
evaluate reamed intramedullary nails in patients with tibial fractures
(S.P.R.I.N.T.): study rationale and design. BMC Musculoskeletal Disord.
2008;9:91.
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Important Information Missing |
20 January 2009 |
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Augusto Sarmiento, MD , Loren L.Latta, PhD
Send letter to journal:
Re: Important Information Missing
asarm{at}bellsouth.net Augusto Sarmiento, MD, et al.
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To the Editor:
We write regarding certain important omissions in the recent article by the SPRINT investigators, "Randomized Trial of Reamed and Unreamed
Intramedullary Nailing of Tibial Shaft Fractures.
No conclusions were presented regarding the infection rate or healing
time of the 1319 adult patients.
No data were presented on final shortening. Shortening after intramedullary
nailing has been reported by a number of investigators. Bone and Johnson (1)
reported 10 mm shortening in 5% of patients, and Hooper et al. reported shortening in 3.4% of patients (2).
Final angulation was not reported. It must have occurred,
particularly in proximal fractures since this problem is well known to
occur frequently.
Perhaps the most important omission was the failure to discuss
chronic knee pain following nailing, and the response to removal of the
implant. Court-Brown reported an incidence of knee pain in 56.2% of
patients, and 24.4% patients required removal of the nail (3). Keating et al.
reported the need for removal of the nail because of knee pain in 80% of
patients, and after 16 months, the pain had not resolved in 36% of the
patients (4). Toivanen et al. reported knee pain in 86% of patients who had a
transtendinous approach, and 81% in patients who had a paratendinous
approach. 69% of their patients had anterior knee pain at an average of
1.5 years after nail removal (5). Quraishi et al. reported that 93.7% of
patients had anterior knee sensory disturbance; 96.8% had pain on
kneeling. Twenty-six percent of his patients had their nail removed. Of
these, 53.5% had persistent anterior knee, 89.5% had anterior sensory knee
disturbance, and 71.4% had pain on kneeling. Metal removal did not
facilitate the desired reduction of symptoms (6). Karladani et al. reported
that nail removal resulted in less pain in 54% of patients but they were not
asymptomatic; pain remained unaltered in 10.7%; and 25% patients had
increased pain (7).
The authors 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.
References
1. Bone L, Johnson K. Treatment of tibial fractures by reaming and
intramedullary nailing. Journ of Bone and Joint Surgery 1986; 68:877-887.
2. Hooper G, Keddell R, Penny I. Conservative management of closed nailing
of tibial shaft fractures: a randomized prospective trial. Jour. Bone
and Joint Surg. Br. 1991;73:83-85.
3. Court-Brown CM, Gustilo T, Shaw AD. Knee pain after intramedullary
nailing: its incidence, etiology, and outcome. J Orthop Trauma 1997;
11(2):103-5.
4. Keating JF, Orfaly R, O’Brien PJ. Knee pain after tibial nailing. J
Orthop Trauma 1997; 11:10-3.
5. Toivanen JA, Vaisto O, Kannus P, Latvala K, Honkonen SE, Jarvinen
MJ.Anterior knee pain after intramedullary nailing of fractures of the
tibial shaft. A prospective, randomized study comparing two different nail
-insertion techniques. J. of Bone Joint Surg [Am] 2002; 84-A (4):580-5.
6. Quraishi NA, Chaudhury A, Boerger TO. Persistent anterior knee pain
following tibial intramedullary nailing [Poster Exhibit]. AAOS Annual
Meeting, 2003. San Francisco, CA, USA.
7. Karladani AH, Ericsson PA, Granhead H, Karlsson L. Nyberg P.
Tibial Intramedullary nails-should they be removed? A retrospective study
of 71 patients. Acta Orthopaedica Scandinavica, 2007 Oct. 78 (5):668-71. |
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