Open fractures of the tibial diaphysis are known to have high rates of nonunion or
delayed union, with widely varying nonunion rates reported to be between 15% and 60% even
in lower Gustilo Anderson grade (types I, II, and IIIA) open fractures. Nonunions are
costly as they require more healthcare services and result in increased patient pain and
disability. A previous study has demonstrated that the use of bone morphogenic protein
(BMP) at the time of definitive tibial shaft fracture fixation significantly reduced the
risk of delayed union. However, BMP is costly and is rarely used for this purpose.
Intramedullary bone graft (IMBG) collected by the reamer-irrigator-aspirator (RIA)
technique has been shown to be effective for producing bone graft to stimulate healing
and treat larger defects in long bones as well as in the treatment of nonunions. However,
the RIA apparatus also introduces and extra expense to the operation and produces more
bone graft than would be needed for packing of the open cortex in non-segmental fractures
without bone loss. The investigator's study aims to determine if packing the exposed
fracture cortex with a small volume of IMBG collected from the tip of a standard reamer
during intramedullary nailing can effectively reduce rate of delayed union and nonunion
in open tibia shaft fractures.
This will be a prospective interventional study with two randomized, parallel groups.
Patients with an open diaphyseal tibial fracture will be considered for study inclusion.
Patients who consent to participate in the study will be randomized to one of two groups.
The first will be the control group. This group will receive the standard of care for
their injury, which consists of irrigation and debridement of the open fracture, reamed
intramedullary nailing and primary wound closure. The second group, the intervention
group, will also undergo irrigation and debridement of the open fracture with reamed
intramedullary nailing, but will also receive a bone graft on the exposed cortex of the
tibial fracture before primarily closing the wound. The bone graft will be made up of the
product of the intramedullary reaming prior to the insertion of the intramedullary nail.
This bone graft will be collected by wiping the reamings from the reamer tip into a
sterile, pre-weighed container after each pass of the reamer through the medullary canal.
Prior to introducing the graft into the exposed cortex, the graft will be weighed so that
a record may be kept of the amount of graft collected and subsequently used in the
procedure.
Each group will then receive identical follow-up care with clinic visits at 2, 8, 16, and
24 weeks post operatively, and will receive X-rays at the 8, 16, and 24 week visits. Each
radiograph will be evaluated and assigned a Radiographic Union Scale in Tibial fractures
(RUST) score by an independent evaluator. Additionally, the Lower Extremity Functional
Scale (LEFS) questionnaire will be administered at enrollment, 8, 16, and 24 week visit
to objectively measure patient progress in functional outcomes. The primary outcome
measurement will be the rate of union of the fracture in both groups at 3 and 6 month
follow up. Radiographic union of the fracture will be defined as the presence of cortical
bridging on at least 3 of the 4 cortices or RUST score >10. Delayed union will be defined
as failure to achieve cortical bridging on 3 of 4 cortices or a RUST score >10 by 6
months. Nonunion will be defined as a fracture that in the opinion of the treating
surgeon has no possibility of healing without further intervention.