Recombinant human BMP-2 and allograft compared with autogenous bone graft for reconstruction of diaphyseal tibial fractures with cortical defects: A randomized, controlled trial

Alan L. Jones, Robert W. Bucholz, Michael J. Bosse, Sohail K. Mirza, Thomas R. Lyon, Lawrence X. Webb, Andrew N. Pollak, Jane Davis Golden, Alexandre Valentin-Opran

Research output: Contribution to journalArticle

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Abstract

Background: Currently, the treatment of diaphyseal tibial fractures associated with substantial bone loss often involves autogenous bone-grafting as part of a staged reconstruction. Although this technique results in high healing rates, the donor-site morbidity and potentially limited supply of suitable autogenous bone in some patients are commonly recognized drawbacks. The purpose of the present study was to investigate the benefit and safety of the osteoinductive protein recombinant human bone morphogenetic protein-2 (rhBMP-2) when implanted on an absorbable collagen sponge in combination with freeze-dried cancellous allograft. Methods: Adult patients with a tibial diaphyseal fracture and a residual cortical defect were randomly assigned to receive either autogenous bone graft or allograft (cancellous bone chips) for staged reconstruction of the tibial defect. Patients in the allograft group also received an onlay application of rhBMP-2 on an absorbable collagen sponge. The clinical evaluation of fracture-healing included an assessment of pain with full weight-bearing and fracture-site tenderness. The Short Musculoskeletal Function Assessment (SMFA) was administered before and after treatment. Radiographs were used to document union, the presence of extracortical bridging callus, and incorporation of the bone-graft material. Results: Fifteen patients were enrolled in each group. The mean length of the defect was 4 cm (range, 1 to 7 cm). Ten patients in the autograft group and thirteen patients in the rhBMP-2/allograft group had healing without further intervention. The mean estimated blood loss was significantly less in the rhBMP-2/allograft group. Improvement in the SMFA scores was comparable between the groups. No patient in the rhBMP-2/allograft group had development of antibodies to BMP-2; one patient had development of transient antibodies to bovine type-1 collagen. Conclusions: The present study suggests that rhBMP-2/allograft is safe and as effective as traditional autogenous bone-grafting for the treatment of tibial fractures associated with extensive traumatic diaphyseal bone loss. Level of Evidence: Therapeutic Level II.

Original languageEnglish (US)
Pages (from-to)1431-1441
Number of pages11
JournalJournal of Bone and Joint Surgery - Series A
Volume88
Issue number7
DOIs
StatePublished - Jul 2006

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Tibial Fractures
Allografts
Randomized Controlled Trials
Transplants
Bone and Bones
Bone Transplantation
Porifera
Collagen
Inlays
Fracture Healing
Antibodies
Autografts
Bony Callus
Weight-Bearing
Pain Measurement
Therapeutics
Collagen Type I
recombinant human bone morphogenetic protein-2
Tissue Donors
Morbidity

ASJC Scopus subject areas

  • Surgery
  • Orthopedics and Sports Medicine

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Recombinant human BMP-2 and allograft compared with autogenous bone graft for reconstruction of diaphyseal tibial fractures with cortical defects : A randomized, controlled trial. / Jones, Alan L.; Bucholz, Robert W.; Bosse, Michael J.; Mirza, Sohail K.; Lyon, Thomas R.; Webb, Lawrence X.; Pollak, Andrew N.; Golden, Jane Davis; Valentin-Opran, Alexandre.

In: Journal of Bone and Joint Surgery - Series A, Vol. 88, No. 7, 07.2006, p. 1431-1441.

Research output: Contribution to journalArticle

Jones, Alan L. ; Bucholz, Robert W. ; Bosse, Michael J. ; Mirza, Sohail K. ; Lyon, Thomas R. ; Webb, Lawrence X. ; Pollak, Andrew N. ; Golden, Jane Davis ; Valentin-Opran, Alexandre. / Recombinant human BMP-2 and allograft compared with autogenous bone graft for reconstruction of diaphyseal tibial fractures with cortical defects : A randomized, controlled trial. In: Journal of Bone and Joint Surgery - Series A. 2006 ; Vol. 88, No. 7. pp. 1431-1441.
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abstract = "Background: Currently, the treatment of diaphyseal tibial fractures associated with substantial bone loss often involves autogenous bone-grafting as part of a staged reconstruction. Although this technique results in high healing rates, the donor-site morbidity and potentially limited supply of suitable autogenous bone in some patients are commonly recognized drawbacks. The purpose of the present study was to investigate the benefit and safety of the osteoinductive protein recombinant human bone morphogenetic protein-2 (rhBMP-2) when implanted on an absorbable collagen sponge in combination with freeze-dried cancellous allograft. Methods: Adult patients with a tibial diaphyseal fracture and a residual cortical defect were randomly assigned to receive either autogenous bone graft or allograft (cancellous bone chips) for staged reconstruction of the tibial defect. Patients in the allograft group also received an onlay application of rhBMP-2 on an absorbable collagen sponge. The clinical evaluation of fracture-healing included an assessment of pain with full weight-bearing and fracture-site tenderness. The Short Musculoskeletal Function Assessment (SMFA) was administered before and after treatment. Radiographs were used to document union, the presence of extracortical bridging callus, and incorporation of the bone-graft material. Results: Fifteen patients were enrolled in each group. The mean length of the defect was 4 cm (range, 1 to 7 cm). Ten patients in the autograft group and thirteen patients in the rhBMP-2/allograft group had healing without further intervention. The mean estimated blood loss was significantly less in the rhBMP-2/allograft group. Improvement in the SMFA scores was comparable between the groups. No patient in the rhBMP-2/allograft group had development of antibodies to BMP-2; one patient had development of transient antibodies to bovine type-1 collagen. Conclusions: The present study suggests that rhBMP-2/allograft is safe and as effective as traditional autogenous bone-grafting for the treatment of tibial fractures associated with extensive traumatic diaphyseal bone loss. Level of Evidence: Therapeutic Level II.",
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T1 - Recombinant human BMP-2 and allograft compared with autogenous bone graft for reconstruction of diaphyseal tibial fractures with cortical defects

T2 - A randomized, controlled trial

AU - Jones, Alan L.

AU - Bucholz, Robert W.

AU - Bosse, Michael J.

AU - Mirza, Sohail K.

AU - Lyon, Thomas R.

AU - Webb, Lawrence X.

AU - Pollak, Andrew N.

AU - Golden, Jane Davis

AU - Valentin-Opran, Alexandre

PY - 2006/7

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N2 - Background: Currently, the treatment of diaphyseal tibial fractures associated with substantial bone loss often involves autogenous bone-grafting as part of a staged reconstruction. Although this technique results in high healing rates, the donor-site morbidity and potentially limited supply of suitable autogenous bone in some patients are commonly recognized drawbacks. The purpose of the present study was to investigate the benefit and safety of the osteoinductive protein recombinant human bone morphogenetic protein-2 (rhBMP-2) when implanted on an absorbable collagen sponge in combination with freeze-dried cancellous allograft. Methods: Adult patients with a tibial diaphyseal fracture and a residual cortical defect were randomly assigned to receive either autogenous bone graft or allograft (cancellous bone chips) for staged reconstruction of the tibial defect. Patients in the allograft group also received an onlay application of rhBMP-2 on an absorbable collagen sponge. The clinical evaluation of fracture-healing included an assessment of pain with full weight-bearing and fracture-site tenderness. The Short Musculoskeletal Function Assessment (SMFA) was administered before and after treatment. Radiographs were used to document union, the presence of extracortical bridging callus, and incorporation of the bone-graft material. Results: Fifteen patients were enrolled in each group. The mean length of the defect was 4 cm (range, 1 to 7 cm). Ten patients in the autograft group and thirteen patients in the rhBMP-2/allograft group had healing without further intervention. The mean estimated blood loss was significantly less in the rhBMP-2/allograft group. Improvement in the SMFA scores was comparable between the groups. No patient in the rhBMP-2/allograft group had development of antibodies to BMP-2; one patient had development of transient antibodies to bovine type-1 collagen. Conclusions: The present study suggests that rhBMP-2/allograft is safe and as effective as traditional autogenous bone-grafting for the treatment of tibial fractures associated with extensive traumatic diaphyseal bone loss. Level of Evidence: Therapeutic Level II.

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