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J Bone Joint Surg Am. 2008 Dec;90(12):2567-78. doi: 10.2106/JBJS.G.01694.

Randomized trial of reamed and unreamed intramedullary nailing of tibial shaft fractures.

Collaborators (252)

Gregory Tennent Sanders DW, MacLeod MD, Carey T, Leitch K, Bailey S, Gurr K, Konito K, Bartha C, Low I, MacBean LV, Ramu M, Reiber S, Strapp R, Tieszer C, Kreder HJ, Stephen DJ, Axelrod TS, Yee AJ, Richards RR, Finkelstein J, Ford M, Gofton W, Murnaghan J, Schatztker J, Bulmer B, Conlan L, Laflamme GY, Berry G, Beaumont P, Ranger P, Laflamme GH, Gagnon S, Malo M, Fernandes J, Poirier MF, Schemitsch EH, McKee MD, Waddell JP, Bogoch ER, Daniels TR, McBroom RR, Vicente MR, Storey W, Wild LM, McCormack R, Perey B, Goetz TJ, Pate G, Penner MJ, Panagiotopoulos K, Pirani S, Dommisse IG, Loomer RL, Stone T, Moon K, Zomar M, Webb LX, Teasdall RD, Birkedal JP, Martin DF, Ruch DS, Kilgus DJ, Pollock DC, Harris MB, Wiesler ER, Ward WG, Shilt JS, Koman AL, Poehling GG, Kulp B, Tornetta P 3rd, Creevy WR, Stein AB, Bono CT, Einhorn TA, Brown TD, Pacicca D, Sledge JB 3rd, Foster TE, Voloshin I, Bolton J, Carlisle H, Shaughnessy L, Obremskey WT, LeCroy CM, Meinberg EG, Messer TM, Craig WL 3rd, Dirschl DR, Caudle R, Harris T, Elhert K, Hage W, Jones R, Piedrahita L, Schricker PO, Driver R, Godwin J, Obremskey WT, Kregor PJ, Tennent G, Truchan LM, Sciadini M, Shuler FD, Driver RE, Nading MA, Neiderstadt J, Vap AR, Vallier HA, Patterson BM, Wilber JH, Wilber RG, Sontich JK, Moore TA, Brady D, Cooperman DR, Davis JA, Cureton BA, Mandel S, Orr RD, Sadler JT, Hussain T, Rajaratnam K, Petrisor B, Bhandari M, Drew B, Bednar DA, Kwok DC, Pettit S, Hancock J, Sidorkewicz N, Cole PA, Smith JJ, Brown GA, Lange TA, Stark JG, Levy BA, Swiontkowski MF, Garaghty MJ, Salzman JG, Schutte CA, Tastad L, Vang S, Seligson D, Roberts CS, Malkani AL, Sanders L, Dyer C, Heinsen J, Smith L, Madanagopal S, Frantz-Bush L, Coupe KJ, Tucker JJ, Criswell AR, Buckle R, Rechter AJ, Sheth DS, Urquart B, Trotscher T, Anders MJ, Kowalski JM, Fineberg MS, Bone LB, Phillips MJ, Rohrbacher B, Stegemann P, Mihalko WM, Buyea C, Augustine SJ, Jackson WT, Solis G, Ero SU, Segina DN, Berrey HB, Agnew SG, Fitzpatrick M, Campbell LC, Derting L, McAdams J, Goslings JC, Ponsen KJ, Luitse J, Kloen P, Joosse P, Winkelhagen J, Duivenvoorden R, Teague DC, Davey J, Sullivan JA, Ertl WJ, Puckett TA, Pasque CB, Tompkins JF 2nd, Gruel CR, Kammerlocher P, Lehman TP, Puffinbarger WR, Carl KL, Weber DW, Jomha NM, Goplen GR, Masson EC, Beaupre LA, Greaves KE, Schaump LN, Jeray KJ, Goetz DR, Westberry DE, Broderick JS, Moon BS, Tanner SL, Powell JN, Buckley RE, Elves L, Connolly S, Abraham EP, Steele T, Ellis T, Herzberg A, Brown GA, Crawford DE, Hart R, Hayden J, Orfaly RM, Vigland T, Vivekaraj M, Bundy GL, Miclau T 3rd, Matityahu A, Coughlin RR, Kandemir U, McClellan RT, Lin CH, Karges D, Cramer K, Watson JT, Moed B, Scott B, Beck DJ, Orth C, Puskas D, Clark R, Jones J, Egol KA, Paksima N, France M, Wai EK, Johnson G, Wilkinson R, Gruszczynski AT, Vexler L.

Abstract

BACKGROUND:

There remains a compelling biological rationale for both reamed and unreamed intramedullary nailing for the treatment of tibial shaft fractures. Previous small trials have left the evidence for either approach inconclusive. We compared reamed and unreamed intramedullary nailing with regard to the rates of reoperations and complications in patients with tibial shaft fractures.

METHODS:

We conducted a multicenter, blinded randomized trial of 1319 adults in whom a tibial shaft fracture was treated with either reamed or unreamed intramedullary nailing. Perioperative care was standardized, and reoperations for nonunion before six months were disallowed. The primary composite outcome measured at twelve months postoperatively included bone-grafting, implant exchange, and dynamization in patients with a fracture gap of <1 cm. Infection and fasciotomy were considered as part of the composite outcome, irrespective of the postoperative gap.

RESULTS:

One thousand two hundred and twenty-six participants (93%) completed one year of follow-up. Of these, 622 patients were randomized to reamed nailing and 604 patients were randomized to unreamed nailing. Among all patients, fifty-seven (4.6%) required implant exchange or bone-grafting because of nonunion. Among all patients, 105 in the reamed nailing group and 114 in the unreamed nailing group experienced a primary outcome event (relative risk, 0.90; 95% confidence interval, 0.71 to 1.15). In patients with closed fractures, forty-five (11%) of 416 in the reamed nailing group and sixty-eight (17%) of 410 in the unreamed nailing group experienced a primary event (relative risk, 0.67; 95% confidence interval, 0.47 to 0.96; p = 0.03). This difference was largely due to differences in dynamization. In patients with open fractures, sixty of 206 in the reamed nailing group and forty-six of 194 in the unreamed nailing group experienced a primary event (relative risk, 1.27; 95% confidence interval, 0.91 to 1.78; p = 0.16).

CONCLUSIONS:

The present study demonstrates a possible benefit for reamed intramedullary nailing in patients with closed fractures. We found no difference between approaches in patients with open fractures. Delaying reoperation for nonunion for at least six months may substantially decrease the need for reoperation.

PMID:
19047701
[PubMed - indexed for MEDLINE]
PMCID:
PMC2663330
Free PMC Article
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