NCT01975467终止不适用
CLAVICLE FRACTURE OUTCOMES: 1-3 YEAR FOLLOW UP OF DISPLACED MIDSHAFT FRACTURES TREATED WITH INTRAMEDULARY NAIL vs. NONOPERATIVE TREATMENT
Sonoma Orthopedic Products, Inc.2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2013年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- DASH Score
研究概览
简要总结
The objective of this post-market clinical study is to compare one to three year post treatment results, range of motion, strength, patient related functional outcomes and patient satisfaction, of internal fixation using the Sonoma Orthopedic Products CRx™ as compared to nonoperative management (e.g. sling) of similar displaced midshaft clavicle fractures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A displaced transverse or oblique midshaft clavicle fracture with or without comminution
- •Must be 12 ± 2 months to 36 ± 2 months post-treatment
- •Must have received nonoperative treatment or operative treatment with a CRx™ device, no other devices, for their clavicle fracture
- •Male or female at least 18 years of age
- •Able to understand the requirements of the study, provide a written informed consent and comply with the study protocol
- •Ability to understand and provide written authorization for use and disclosure of personal health information
排除标准
- •Open, or segmental clavicle fracture
- •Any clavicle or upper extremity fracture previous, concurrent, or subsequent to the study fracture
- •Removal of the CRx™ device within 8 weeks of the study visit
- •History of alcoholism
- •Currently on chemotherapy or radiation therapy
- •Habitual use of narcotic pain medications prior to injury or after injury for reasons other than clavicle pain
- •Currently on worker's compensation
- •History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
- •Rheumatoid arthritis or other inflammatory arthropathies.
- •History of chronic pain issues for reasons other than clavicle pain or psychiatric disorder that precludes reliable follow-up.
- •Women that are pregnant or think that they might be pregnant
结局指标
主要结局
DASH Score
时间窗: One time point
Subjects that are one to three years post-treatment will undergo an evaluation of fracture outcome utilizing the DASH instrument for function.
次要结局
- Range of Motion and Strength(One time point)
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
不适用
A Post Market Clinical Follow-up Study With the aneXys CupArthroplasty, Replacement, HipNCT03274830Mathys Ltd Bettlach102
已完成
不适用
DePuy Trochanteric (ATN) Nailing Clinical Outcomes TrialFemoral Fracture (Proximal)NCT00546429DePuy Orthopaedics62
终止
不适用
Safety Study of Femoral Neck Fracture SystemFemoral Neck FracturesNCT03721835Smith & Nephew, Inc.15
Enrolling By Invitation
不适用
Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius ImplantArthroplasty, Replacement, ShoulderGlenoid CavityOsteoarthritis of the ShoulderNCT03806881Materialise24
招募中
不适用
Clavicle fracture surgical methodsIRCT20211201053235N1Shahid Beheshti University of Medical Sciences30