BACKGROUND:Recombinant human bone morphogenetic protein-2 (rhBMP-2) applied on an absorbable collagen sponge improves open tibial fracture-healing as an adjunct to unreamed intramedullary nail fixation. We evaluated rhBMP-2 and a new, injectable calcium phosphate matrix (CPM) formulation in acute closed tibial diaphyseal fractures treated withreamed intramedullary nail fixation. METHODS: Patients were randomized (1:2:2:1) to receive standard of care, which consisted of definitive fracture fixation within seventy-two hours of injury with a locked intramedullary nail after reaming; standard of care and injection with 1.0 mg/mL of rhBMP-2/CPM; standard of care and injection with 2.0 mg/mL of rhBMP-2/CPM; or standard of care and injection with buffer/CPM, to evaluate the activity of the CPM delivery matrix and provide for sponsor and investigator blinding. The co-primary end points of the study were the effects of rhBMP-2/CPM on the time to fracture union (based on blinded assessment of radiographs) and the time to return to normal function (based on blinded assessment of the time to full weight-bearing without pain at the fracture site) compared with standard of care alone. RESULTS:Three hundred and sixty-nine patients were randomized and included in the intent-to-treat population. This study was terminated after an interim analysis (180 patients with six months of follow-up) revealed no shortening in the time to fracture union in the active treatment arms compared with the standard of care control (the SOC group). In the final primary analysis, the median time to radiographic fracture union was not significantly different for the SOC (13.1 weeks), 1.0-mg/mL rhBMP-2/CPM (13.0 weeks), 2.0-mg/mL rhBMP-2/CPM (15.9 weeks), or buffer/CPM (15.4 weeks) treatment groups. The median time to pain-free full weight-bearing was also not significantly different among the SOC (13.4 weeks), 1.0-mg/mL rhBMP-2/CPM (13.4 weeks), 2.0-mg/mL rhBMP-2/CPM (14.3 weeks), and buffer/CPM (16.4 weeks) treatment groups. CONCLUSIONS: In patients with closed tibial fractures treated withreamed intramedullary nailing, the time to fracture union and pain-free full weight-bearing were not significantly reduced by rhBMP-2/CPM compared with standard of care alone. 24306696
RCT Entities:
BACKGROUND: Recombinant humanbone morphogenetic protein-2 (rhBMP-2) applied on an absorbable collagen sponge improves open tibial fracture-healing as an adjunct to unreamed intramedullary nail fixation. We evaluated rhBMP-2 and a new, injectable calcium phosphate matrix (CPM) formulation in acute closed tibial diaphyseal fractures treated with reamed intramedullary nail fixation. METHODS:Patients were randomized (1:2:2:1) to receive standard of care, which consisted of definitive fracture fixation within seventy-two hours of injury with a locked intramedullary nail after reaming; standard of care and injection with 1.0 mg/mL of rhBMP-2/CPM; standard of care and injection with 2.0 mg/mL of rhBMP-2/CPM; or standard of care and injection with buffer/CPM, to evaluate the activity of the CPM delivery matrix and provide for sponsor and investigator blinding. The co-primary end points of the study were the effects of rhBMP-2/CPM on the time to fracture union (based on blinded assessment of radiographs) and the time to return to normal function (based on blinded assessment of the time to full weight-bearing without pain at the fracture site) compared with standard of care alone. RESULTS: Three hundred and sixty-nine patients were randomized and included in the intent-to-treat population. This study was terminated after an interim analysis (180 patients with six months of follow-up) revealed no shortening in the time to fracture union in the active treatment arms compared with the standard of care control (the SOC group). In the final primary analysis, the median time to radiographic fracture union was not significantly different for the SOC (13.1 weeks), 1.0-mg/mL rhBMP-2/CPM (13.0 weeks), 2.0-mg/mL rhBMP-2/CPM (15.9 weeks), or buffer/CPM (15.4 weeks) treatment groups. The median time to pain-free full weight-bearing was also not significantly different among the SOC (13.4 weeks), 1.0-mg/mL rhBMP-2/CPM (13.4 weeks), 2.0-mg/mL rhBMP-2/CPM (14.3 weeks), and buffer/CPM (16.4 weeks) treatment groups. CONCLUSIONS: In patients with closed tibial fractures treated with reamed intramedullary nailing, the time to fracture union and pain-free full weight-bearing were not significantly reduced by rhBMP-2/CPM compared with standard of care alone. 24306696
Authors: Fereydoon Sargolzaei Aval; Mohammad R Arab; Narjes Sargolzaei; Sanam Barfrushan; Mohsen Mir; Gholam H Sargazi; Forough Sargolzaeiaval; Maryam Arab Journal: Arch Bone Jt Surg Date: 2019-03
Authors: Leo Massari; Francesco Benazzo; Francesco Falez; Ruggero Cadossi; Dario Perugia; Luca Pietrogrande; Domenico Costantino Aloj; Antonio Capone; Michele D'Arienzo; Matteo Cadossi; Vincenzo Lorusso; Gaetano Caruso; Matteo Ghiara; Luigi Ciolli; Filippo La Cava; Marco Guidi; Filippo Castoldi; Giuseppe Marongiu; Alessandra La Gattuta; Dario Dell'Omo; Michelangelo Scaglione; Sandro Giannini; Mattia Fortina; Alberto Riva; Pier Luigi De Palma; Antonio Pompilio Gigante; Biagio Moretti; Giuseppe Solarino; Francesco Lijoi; Giovanni Giordano; Pier Giorgio Londini; Danilo Castellano; Giuseppe Sessa; Luciano Costarella; Antonio Barile; Mariano Borrelli; Attilio Rota; Raffaele Fontana; Alberto Momoli; Andrea Micaglio; Guido Bassi; Rossano Stefano Cornacchia; Claudio Castelli; Michele Giudici; Mauro Monesi; Luigi Branca Vergano; Pietro Maniscalco; M'Putu Bulabula; Vincenzo Zottola; Auro Caraffa; Pierluigi Antinolfi; Fabio Catani; Claudio Severino; Enrico Castaman; Carmelo Scialabba; Venceslao Tovaglia; Pietro Corsi; Paolo Friemel; Marco Ranellucci; Vincenzo Caiaffa; Giovanni Maraglino; Roberto Rossi; Antonio Pastrone; Patrizio Caldora; Claudio Cusumano; Pier Bruno Squarzina; Ugo Baschieri; Ettore Demattè; Stefano Gherardi; Carlo De Roberto; Alberto Belluati; Antonio Giannini; Ciro Villani; Pietro Persiani; Silvio Demitri; Bruno Di Maggio; Guglielmo Abate; Francesca De Terlizzi; Stefania Setti Journal: Biomed Res Int Date: 2018-04-30 Impact factor: 3.411