There is limited long term evidence to support instrumented fusion as an adjunct to decompression for foraminal stenosis in the presence of single level degenerative disc disease. We report the long term outcome of a prospective randomised controlled trial. Forty-four patients with single-level disc disease were randomly assigned to three groups (spinal decompression (Group 1), decompression and instrumented posterolateral fusion (Group 2), or decompression and instrumented posterolateral fusion plus transforaminal interbody fusion (Group 3). Spinal disability (Dallas, Roland Morris, and Lower Back Outcome Score [LBOS]), and quality of life (EuroQol (EQ) and short form (SF-) 36 questionnaires) were assessed before and at after surgery by independent researchers. At mean of 15 years follow up 33 (75%) patients were available for assessment. All groups observed a significant improvement in the EQ-5D at final follow up. Group 1 demonstrated significantly better functional outcome at final follow up according to the Dallas, Roland Morris, LBOS, and EQ-5D (3L and VAS) scores when compared to the other two groups (p<0.01). The SF-36 score demonstrated that group 1 had significantly better generic health scores compared to groups 2 and 3. Regression analysis was used to adjust for the differences in general health between the groups and demonstrated no significant difference between the groups in the spine specific scores: Dallas (p>0.15), Roland Morris (p>0.37), or the LBOS (p>0.32). Fusion in combination with decompression for the treatment of foraminal stenosis and single level degenerative disc disease offers no long term functional benefit over decompression in isolation

Objectives. The aim of this systematic literature review was to assess the clinical level of evidence of commercially available demineralised bone matrix (DBM) products for their use in trauma and orthopaedic related surgery. Methods. A total of 17 DBM products were used as search terms in two available databases: Embase and PubMed according to the Preferred Reporting Items for Systematic Reviews and Meta Analyses statement. All articles that reported the clinical use of a DBM-product in trauma and orthopaedic related surgery were included. Results. The literature search resulted in 823 manuscripts of which 64 manuscripts met the final inclusion criteria. The included manuscripts consisted of four randomised controlled trials (level I), eight cohort studies (level III) and 49 case-series (level IV). No clinical studies were found for ten DBM products, and most DBM products were only used in combination with other grafting materials. DBM products were most extensively investigated in spinal surgery, showing limited level I evidence that supports the use Grafton DBM (Osteotech, Eatontown, New Jersey) as a bone graft extender in posterolateral lumbar fusion surgery. DBM products are not thoroughly investigated in trauma surgery, showing mainly level IV evidence that supports the use of Allomatrix (Wright Medical, London, United Kingdom), DBX (DePuy Synthes, Zuchwil, Switzerland), Grafton DBM, or OrthoBlast (Citagenix Laval, Canada) as bone graft extenders. Conclusions. The clinical level of evidence that supports the use of DBM in trauma and orthopaedic surgery is limited and consists mainly of poor quality and retrospective case-series. More prospective, randomised controlled trials are needed to understand the clinical effect and impact of DBM in trauma and orthopaedic surgery. Cite this article: J. van der Stok, K. A. Hartholt, D. A. L. Schoenmakers, J. J. C. Arts. The available evidence on demineralised bone matrix in trauma and orthopaedic surgery: A systemati c review. Bone Joint Res 2017;6:423–432. DOI: 10.1302/2046-3758.67.BJR-2017-0027.R1

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: Bone Joint J 2013;95-B:583–97.