ACTRN12608000052336尚未招募1 期
A Prospective, Randomized, Controlled, Pilot Clinical Study to Evaluate GEMOS2 (ß-TCP/collagen matrix combined with rhPDGF-BB) for the Treatment of Unstable Distal Radius Fractures
BioMimetics Therapeutics Inc0 个研究点目标入组 20 人开始时间: 2008年1月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Subjects who meet the following criteria may be included in the study if they present with all of
- •the following:
- •1) The subject has signed the Independent Ethics Committee (IEC) approved Informed
- •Consent Form specific to this study prior to enrollment
- •2) The subject has an unstable unilateral, extraarticular distal radius fracture classified as
- •unstable with the following radiographic findings: wide displacement requiring reduction
- •defined as >10° or 20° volar tilt or instability defined as 20° dorsal tilt; or an intraarticular
- •fracture that is amenable to external-fixation or closed fracture reduction.
- •Avulsed ulnar styloid tip is allowed
- •3) The subject’s fracture is able to be manually reduced in a single attempt up to 2 weeks
- •post injury
- •4) The subject is independent, ambulatory, and can comply with all post-treatment
- •evaluations and visits
- •5) The subject is skeletally mature and =18 years of age
- •6) The distal radius fracture does not require structural bone graft.
排除标准
- •Subjects will be excluded from the study if they present with any of the following:
- •1) The subject has suffered a previous wrist fracture on the affected wrist or contralateral
- •wrist within the previous 12 months of the current fracture date
- •2) The subject’s fracture meets any of the following criteria:
- •Bilateral distal radius fractures or clinically significant injury to the contralateral limb.
- •Severe comminution involving the diaphysis of the radius and/or radioulnar joint.
- •Ulnar fracture (AO: A1.1, A1.2, and A1.3)
- •Presence of pre-operative hard or soft tissue infection at the operative site.
- •Requires supplemental internal fixation for adequate reduction (e.g. plates)
- •Open fractures
- •Closed head injuries
- •Intra-articular fracture with diastasis of the subchondral bone
- •3) The subject is currently undergoing radiotherapy or chemotherapy
- •4) The subject has a metabolic disorder known to adversely affect the skeleton, other than primary osteoporosis (e.g., renal osteodystrophy)
- •5) The subject uses chronic medications known to affect the skeleton (e.g. glucocorticoid usage > 10mg/day). Note: NSAID use is excluded during the first 6 weeks post-treatment
- •6) The subject has a clotting disorder or uses anticoagulant therapy (e.g., coumadin). Antiplatelet therapy is acceptable for daily cardiovascular maintenance
- •7) The subject has a pre-fracture neuromuscular or musculoskeletal deficiency which limits the ability to perform objective functional measurements
- •8) The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, etc.)
- •9) The subject has an allergy to yeast-derived products
- •10) Allergy to bovine collagen and/or to other bovine source medication, supplements or products
- •11) The subject is enrolled in another device or drug investigational study (currently or within the past 30 days of surgery or during the follow-up phase of this study)
- •12) The subject is a prisoner, is known or suspected to be transient, or has a history of drug/alcohol abuse (as determined by investigator) within the 12 months prior to screening for study entry
- •13) The subject is pregnant or a female intending to become pregnant during this study period.
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