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


METHODS
Therapeutic Level II. See Instructions to Authors for a complete description of levels of evidence.
Jones
Alan L
AL
University of Texas Southwestern Medical Center, Dallas, TX, USA.
Bucholz
Robert W
RW
Bosse
Michael J
MJ
Mirza
Sohail K
SK
Lyon
Thomas R
TR
Webb
Lawrence X
LX
Pollak
Andrew N
AN
Golden
Jane Davis
JD
Valentin-Opran
Alexandre
A
D000328:Adult; D055396:Bone Morphogenetic Protein 2; D019485:Bone Morphogenetic Proteins / Q000008:administration & dosage*; D016025:Bone Transplantation; D003094:Collagen; D003131:Combined Modality Therapy; D018483:Diaphyses / Q000293:injuries; D005500:Follow-Up Studies; D006801:Humans; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage*; D015503:Surgical Sponges; D013978:Tibial Fractures / Q000628:therapy*; D016212:Transforming Growth Factor beta / Q000008:administration & dosage*; D014182:Transplantation, Autologous; D016896:Treatment Outcome
D055396:Bone Morphogenetic Protein 2; D019485:Bone Morphogenetic Proteins; D011994:Recombinant Proteins; D016212:Transforming Growth Factor beta; C499469:recombinant human bone morphogenetic protein-2; D003094:Collagen