To clarify the effectiveness of the induced membrane technique (IMT) using beta-tricalcium phosphate (β-TCP) for reconstruction of segmental bone defects by evaluating clinical and radiological outcomes, and the effect of defect size and operated site on surgical outcomes. A review of the medical records was conducted of consecutive 35 lower limbs (30 males and five females; median age 46 years (interquartile range (IQR) 40 to 61)) treated with IMT using β-TCP between 2014 and 2018. Lower Extremity Functional Score (LEFS) was examined preoperatively and at final follow-up to clarify patient-centered outcomes. Bone healing was assessed radiologically, and time from the second stage to bone healing was also evaluated. Patients were divided into ≥ 50 mm and < 50 mm defect groups and into femoral reconstruction, tibial reconstruction, and ankle arthrodesis groups.Aims
Methods
We report the outcome of 84 nonunions involving
long bones which were treated with rhBMP-7, in 84 patients (60 men:
24 women) with a mean age 46 years (18 to 81) between 2003 and 2011.
The patients had undergone a mean of three previous operations (one
to 11) for nonunion which had been present for a mean of 17 months
(4 months to 20 years). The nonunions involved the lower limb in
71 patients and the remainder involved the upper limb. A total of 30
nonunions were septic. Treatment was considered successful when
the nonunion healed without additional procedures. The relationship
between successful union and the time to union was investigated
and various factors including age and gender, the nature of the
nonunion (location, size, type, chronicity, previous procedures,
infection, the condition of the soft tissues) and type of index
procedure (revision of fixation, type of graft, amount of rhBMP-7) were
analysed. The improvement of the patients’ quality of life was estimated
using the Short Form (SF) 12 score. A total of 68 nonunions (80.9%) healed with no need for further
procedures at a mean of 5.4 months (3 to 10) post-operatively. Multivariate
logistic regression analysis of the factors affecting union suggested
that only infection significantly affected the rate of union
(p = 0.004).Time to union was only affected by the number of previous
failed procedures
(p = 0.006). An improvement of 79% and 32.2% in SF-12 physical and
mental score, respectively, was noted within the first post-operative
year. Rh-BMP-7 combined with bone grafts, enabled healing of the nonunion
and improved quality of life in about 80% of patients. Aseptic nonunions
were much more likely to unite than septic ones. The number of previous
failed operations significantly delayed the time to union. Cite this article:
We reviewed 59 bone graft substitutes marketed
by 17 companies currently available for implantation in the United Kingdom,
with the aim of assessing the peer-reviewed literature to facilitate
informed decision-making regarding their use in clinical practice.
After critical analysis of the literature, only 22 products (37%)
had any clinical data. Norian SRS (Synthes), Vitoss (Orthovita),
Cortoss (Orthovita) and Alpha-BSM (Etex) had Level I evidence. We question
the need for so many different products, especially with limited
published clinical evidence for their efficacy, and conclude that
there is a considerable need for further prospective randomised
trials to facilitate informed decision-making with regard to the
use of current and future bone graft substitutes in clinical practice. Cite this article:
