Discussion on Clinical Trial Design of Artificial Hip Prosthesis / 中国医疗器械杂志

Recently, the registration of artificial hip prosthesis products increased year by year. In the new version of the provisions for medical device registration, the domestic or import of such products in the registration declaration may need to complete a clinical trial in the country. How to carry out scientific clinical trials of the product design is the common concern of enterprises and clinical trial institutions. To review the guideline and literature concerning registration for artificial hip prosthesis, the focus on clinical trial design of artificial hip prosthesis include clinical inclusion, evaluation standard, sample size. Through the discussion, we hope to provide advice and guidance for clinical trials of this kind of products.

Comparison of the effects and complications of biotype and cement-based artificial hip prosthesis in the treatment of femoral neck fracture in the elderly / 中国综合临床

Objective To compare the effects and complications of biotype and cement-based artificial hip prosthesis in the treatment of femoral neck fracture in the elderly.Methods Seventy elderly patients with femoral neck fractures were selected as the subjects and were randomly divided into the bone-cement group(35 cases)and the biomaterials group(35 cases),the bone-cement group received cement-based artificial hip prosthesis,the biomaterials group received biotype artificial hip prosthesis,the perioperative clinical indicators and follow -up indicators of both group were compared.Results The operative time of the bone-cement group was(61.2±11.3)min,longer than that in the biomaterials group((53.3±10.4)min),the difference was statistically significant(P<0.05),while the postoperative partial load bearing time was(4.0 ± 1.6)d,the postoperative full load bearing time was(30.3 ± 6.8)d and the hospital stay time was(18.2 ± 2.4)d, significantly shorter than that in the biomaterials group((20.7 ± 2.2)d),the differences were statistically significant(P<0.05),the intraoperative blood loss((175.3±40.3)ml)and the postoperative bleeding volume ((120.4±33.2)ml)were less than those in the biomaterials group((213.3±30.4)ml,(185.5±26.6)ml) (P<0.05).The total incidence rate of bone cement complication of the bone-cement group was 11.43%,which were lower than that of the biomaterials group(34.29%),the difference was statistically significant(P<0.05) .The Harris score and Barthel life index score of the bone-cement group were significantly higher than those of the biomaterials group(P<0.05),The rate of hip function recovery was significantly higher than that of the biomaterials group(P<0.05).Conclusion Compared with the biotype artificial hip prosthesis,the cement-based artificial hip prosthesis has advantages of rapid clinical improvement, good prognosis and less complication,especially suitable for the treatment of femoral neck fracture in the elderly.