BAG-S53P4 has similar mechanical properties as cortical bone tissue and can be used as an additive to bone allografts. The aim of this study was to evaluate the effect of adding BAG-S53P4 to chemically treated allografts with controlled grain size distribution. Allografts were prepared and chemically cleaned under sterile conditions. 30 samples were mixed with BAG-S53P4 additive (BG) and compared to a control group (CG) with similar grain size distribution and composition in weight. All samples underwent a uniaxial compression test after compaction with a dropped weight apparatus. The yield limit was determined by a uniaxial compression test and density was recorded. The two groups were tested for statistical differences with the student's t-Test.Introduction
Methods
By contrast, worldwide Register data refer to 733,000 primary operations, i.e. approximately 10 times as many as sample-based datasets. In general, sample-based datasets present higher revision rates than register data. The deviations are high, with a maximum factor of 64 for hip stems. Whereas the AAHKS survey exhibits lower deviations than the monocentre trials, they are still too high for this data collection tool being considered as reliable and safe to provide valid data for general conclusions. The incidence of implant fractures after total hip arthroplasty in pooled worldwide arthroplasty register datasets is 304 fractures per 100.000 implants. In other words, one out of 323 patients has to undergo revision surgery due to an implant fracture after THA in their lifetime.
For the detection of rare, but severe complications like implant fractures sample-based studies achieve the goal of providing accurate figures only to a very limited extent, even if the samples are large. Here, too, comprehensive national arthroplasty registers are the most suitable tool to identify such incidents and calculate reliable figures. Contrary to the prevalent opinion, implant fractures still are a relevant problem in arthroplasty.
The average revision rate in peer reviewed literature is significantly lower than in arthroplasty register data-sets. Studies published by the inventor of an implant tend to show superior outcome compared to independent publications and Arthroplasty Register data. Factors of 4 to more than 10 have been found, which has a significant impact for the results of Metaanalyses. When an implant is taken from the market or replaced by a successor there is a significant decrease in publications, which limits the detection of failure mechanisms such as PE wear or insufficient locking mechanisms. The final statement made about the product under investigation seem to follow a certain mainstream.
VAS neck pain: Fusion group/arthroplasty group: Preoperatively 6.2/5.9 n.s., 6 weeks 3.5/3.1 n.s., 12 weeks 2.1/1.9 n.s, 1 year 2/2.1 n.s. VAS arm pain: Fusion group/arthroplasty group: Preoperatively 5.5/5.3 n.s., 6 weeks 2.6/2.4 n.s., 12 weeks 1.7/1.8 n.s, 1 year 2/1.9 n.s. Neck disability index: Fusion group/arthroplasty group: Preoperatively 43/40 n.s., 6 weeks 28/23 p<
0.05., 12 weeks 18/14 p<
0.05, 1 year 20/15 p<
0.05. SF-36 subscore pain: Fusion group/arthroplasty group: Preoperatively 36/37 n.s., 6 weeks 42/44 n.s., 12 weeks 52/58 p<
0.05, 1 year 52/60 p<
0.05. SF-36 subscore function: Fusion group/arthroplasty group: Preoperatively 52/54 n.s., 6 weeks 57/59 n.s., 12 weeks 60/62 n.s, 1 year 64/67 n.s. SF-36 subscore vitality: Fusion group/arthroplasty group: Preoperatively 42/44 n.s., 6 weeks 45/46 n.s., 12 weeks 50/52 n.s, 1 year 54/56 n.s. In the fusion group we had 1 recurrent radiculopathy and 1 non union without the need of further intervention. In the arthroplasty group we faced 1 recurrent laryngeus recurrens nerve palsy and 3 spontaneus fusions within 1 year postoperatively, which might not be classified as complication.