Randomized Prospective Cohort Study Comparing Efficacy of Bone Marrow Aspirate Concentrate Combined With Cryopreserve Allograft Bone in the Treatment of Intra-Articular Calcaneal Fractures
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Percentage of participant with satisfactory bone healing using American Orthopedics Foot and Ankle Society (AOFAS) ankle-hindfoot scoring system
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of BMAC when used in conjunction with viable allograft bone for treating displaced intra-articular calcaneal fractures, in terms of rate of allograft incorporation into the host tissue, bone healing, and functional outcome.
详细描述
The study group will consist of patients with intra-articular calcaneal fractures admitted to our academic level I trauma center that underwent open reduction internal fixation. Inclusion criteria will be patients with a closed displaced intra-articular fracture Sanders type III without any evidence of neurovascular injury. Patients will be randomly divided into three groups according to the plan of management: autograft alone, viable allograft combined with BMAC, or viable allograft alone. Radiographic imaging and three-dimensional standing computed tomography will be used to assess the articular surface, Bohler's angle, the crucial angle of Gissane, and the height, width and length of the calcaneus. The American Orthopedic Foot and Ankle Society (AOFAS) ankle-hind-foot scoring system and visual analog scale (VAS) will be used to post-operative evaluation of the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Closed displaced intra-articular fracture without any evidence of nerve or blood vessel injury, the fractures belonged to Sanders type III according to Sanders classification and amenable to open reduction internal fixation
- •Life expectancy of at least 1 year
- •Patient is willing to provide informed consent, is geographically stable and able to comply with the required follow up visits, testing schedule and medication regimen
- •Adequate soft tissue coverage at the fracture site through primary closure.
- •Unilateral or bilateral calcaneal fractures.
排除标准
- •Pregnant or breastfeeding women or planning on becoming pregnant during the investigational period
- •Patient is currently participating in an investigational drug or other device study or previously enrolled in this study.
- •Uncontrolled diabetes mellitus (hemoglobin A1c levels > 10%)
- •A current endocrine or metabolic disorder known to affect osteogenesis
- •Currently has untreated malignant neoplasm(s), or is currently undergoing radiation therapy or chemotherapy.
- •Inadequate neurovascular status in the involved limb that may jeopardize healing.
- •Patients who have a preexisting calcaneus deformity that cannot accommodate a reduction or a previous history of osteomyelitis in the index limb.
- •Other ipsilateral lower extremity fracture(s) if, in the opinion of the investigator, the treatment and/or rehabilitation of such fracture(s) will substantially interfere with the treatment, rehabilitation or other requirements outlined in this protocol.
结局指标
主要结局
Percentage of participant with satisfactory bone healing using American Orthopedics Foot and Ankle Society (AOFAS) ankle-hindfoot scoring system
时间窗: baseline to 52 weeks
The AOFAS ankle-hindfoot scoring system is the most commonly used instruments for measuring the outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It combines a clinician-reported and a patient-reported part. The scoring system range is from 0 to 100 with 100 being the best outcome score.
Percentage of patient with satisfactory post treatment pain with Visual Analogue Scale (VAS)
时间窗: baseline to 52 weeks
The visual analogue scale or visual analog scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. Scale ranges from 0 to 10 with 10 being worse.
次要结局
未报告次要终点
研究者
Michael Johnson
Associate Professor
University of Alabama at Birmingham