Nordic DeltaCon Trial: Non-operative Treatment Versus Reversed Total Shoulder Prosthesis in Patients Sixty Five Years of Age and Older With Displaced 3- and 4 Parts Proximal Humeral Fractures - a Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 154
- 试验地点
- 3
- 主要终点
- Quick-DASH
研究概览
简要总结
The Nordic DeltaCon Trial is a prospective, single-blinded, randomized, controlled, multi-center and multi-national trial comparing reverse prosthesis and non-operative treatment in displaced proximal humerus fractures, in the elderly patients aged 65 to 85 years with displaced OTA/AO group B2 or C2 fractures (According to the new 2018 revision: AO/OTA (Orthopaedic Trauma Association) group 11-B1.1, 11-B1.2 and 11-C1.1, 11-C3.1. )
详细描述
Single-blinded, multi-center, multi-national (Finland, Sweden, Denmark, Norway) Primary outcome in this study is QuickDASH (The short form of Disabilities of the arm, shoulder and hand) score measured at two years.
Secondary outcomes are QuickDASH at/after one, two (short term) and five years (medium term), general visual analog scale (VAS) for pain, Oxford shoulder score (OSS), Constant-score (CS), number of re-operations and complications. Quality of life is assessed with 15-D. Cost-effectiveness analysis will be performed after completion of the trial.
In addition to 2 years main outcome (short term) follow-up will continue to 5 years (medium term) and 10 years (long term). The power calculation is based on 2 years.
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
- Single (Outcomes Assessor)
盲法说明
Physiotheraphists specialized in shoulder injuries collect all data and perform all tests / interviews of patients during FU at 3 months, 1-2-5 years. Blinded for the allocation / treatment.
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low energy AO/OTA group 11-B1.1, 11-B1.2 and 11-C1.1, 11-C3.
- •Both B and C type includes subgroups: Displaced [2], Impacted [3] or Non impacted [4] from the universal modifiers list.
排除标准
- •Radiographic Mal-inclination Less than; varus 30°or valgus 45° Less than 50% contact between head fragment and meta-/diaphysis Head split fractures with more than 10% of the articular surface in the main head fragment.
- •Head split fractures (group 11-C3.2 and 11-C3.3) with more than 10% of the articular surface in the main head fragment.
- •Dislocation or fracture-dislocation of the gleno-humeral joint Pathological fracture
- •Refuse to participate
- •Age under 65 years of age, or over 85 years of age
- •Serious poly-trauma or additional surgery
- •Non-independent, drug/alcohol abuse or institutionalized (low co-operation)
- •Contra-indications for surgery
- •Does not understand written and spoken guidance in local languages
- •Previous fracture with symptomatic sequelae in either shoulder
- •Patients living outside the hospital's catchment area
结局指标
主要结局
Quick-DASH
时间窗: From enrollment to 5 years follow-up. Scale 1-4 points (Total point x answers given) x25. Lowest point best
The short form of Disabilities of the arm, shoulder and hand
次要结局
- Patient involvement(2 years)
- Oxford Shoulder Score(From enrollment to 5 years follow-up. Scale 0 - 48, lowest score best.)
- Constant score (CS)(From enrollment to 5 years follow-up. Scale 0- 100 points. Highest best if only actual shoulder is scored..)
- 15 D Quality of Life(From enrollemtn to 5 years follow-up. 15 questions, 5 levels, scale 0.000 - 1.000. Highest number best.)
- VAS pain(From enrollement to 5 eyars follow-up. Scale 0-15 points, best equal zero points)
- Radiographic + Computer Tomography scan (CT)(From enrollemnt to 5 years follow-up for plain radiographs. CT at enrollement and at 2 years.)
- Patient involvement(2 years)
研究者
Tore Fjalestad
Principal investigator Tore Fjalestad, MD. Ph.D. Consultant Orthopaedic Surgeon, Mail: torfja@online.no / tofjal@ous-hf.no , Ph:+4797013389
Oslo University Hospital