Chesser T J S, Fox R, Harding K, Halliday R, Barnfield S, Willett K, Lamb S, Yau C, Javaid M K, Gray A C, Young J, Taylor H, Shah K, Greenwood R
Southmead Hospital, North Bristol NHS Trust, Bristol, BS10 5NB, UK.
Kadoorie Research Centre, John Radcliffe Hospital, Headley Way, Oxford OX9 3DU, UK.
Bone Joint J. 2016 Jun;98-B(6):840-5. doi: 10.1302/0301-620X.98B6.36794.
We wished to assess the feasibility of a future randomised controlled trial of parathyroid hormone (PTH) supplements to aid healing of trochanteric fractures of the hip, by an open label prospective feasibility and pilot study with a nested qualitative sub study. This aimed to inform the design of a future powered study comparing the functional recovery after trochanteric hip fracture in patients undergoing standard care, versus those who undergo administration of subcutaneous injection of PTH for six weeks.
We undertook a pilot study comparing the functional recovery after trochanteric hip fracture in patients 60 years or older, admitted with a trochanteric hip fracture, and potentially eligible to be randomised to either standard care or the administration of subcutaneous PTH for six weeks. Our desired outcomes were functional testing and measures to assess the feasibility and acceptability of the study.
A total of 724 patients were screened, of whom 143 (20%) were eligible for recruitment. Of these, 123 were approached and 29 (4%) elected to take part. However, seven patients did not complete the study. Compliance with the injections was 11 out of 15 (73%) showing the intervention to be acceptable and feasible in this patient population.
Only 4% of patients who met the inclusion criteria were both eligible and willing to consent to a study involving injections of PTH, so delivering this study on a large scale would carry challenges in recruitment and retention. Methodological and sample size planning would have to take this into account. PTH administration to patients to enhance fracture healing should still be considered experimental. Cite this article: Bone Joint J 2016;98-B:840-5.
我们希望通过一项开放标签的前瞻性可行性和试点研究以及一项嵌套的定性子研究,评估未来进行甲状旁腺激素(PTH)补充剂辅助髋部转子间骨折愈合的随机对照试验的可行性。这旨在为未来一项有足够样本量的研究设计提供信息,该研究将比较接受标准治疗的髋部转子间骨折患者与接受皮下注射PTH六周的患者的功能恢复情况。
我们进行了一项试点研究,比较60岁及以上因髋部转子间骨折入院且有可能被随机分配至标准治疗组或接受皮下注射PTH六周治疗组的患者髋部转子间骨折后的功能恢复情况。我们期望的结果是功能测试以及评估该研究可行性和可接受性的指标。
共筛选了724例患者,其中143例(20%)符合纳入标准。在这些符合标准的患者中,123例被邀请参与研究,29例(4%)选择参加。然而,7例患者未完成研究。注射的依从性为15例中有11例(73%),表明该干预措施在该患者群体中是可接受且可行的。
在符合纳入标准的患者中,只有4%的患者既符合条件又愿意同意参与一项涉及注射PTH的研究,因此大规模开展这项研究在招募和留住患者方面会面临挑战。方法学和样本量规划必须考虑到这一点。对患者使用PTH促进骨折愈合仍应被视为试验性的。引用本文:《骨与关节杂志》2016年;98 - B:840 - 845。