Comparison Between the Entry Portals Through the Rotator Cuff and Through the Rotator Interval Split for Anterograde Humeral Nailing in Humeral Fractures: a Prospective Randomized Study
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- University Hospital, Clermont-Ferrand
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Speed of functional recovery
概览
简要总结
The aim of the study is to show if there is any speed difference of functional recovery for people with humeral fracture, treated by an anterograde nail, which will be inserted through the rotator cuff (the common way) or through the rotator interval split.
The patients included in this study will be randomized to one of the two groups.
The recovery will be evaluated by the Constant score over time, for a year. The main hypothesis is the rotator interval split approach allows a faster functional recovery after humeral nailing, by avoiding opening the rotator cuff.
详细描述
Humeral fractures are the third most common fractures over 65 years and represent 8% of all fractures. The anterograde nailing is known to be an efficient way to treat humeral upper extremity fractures and humeral diaphysis fractures. The main complications of this nailing are pain, shoulder stiffness, rotator cuff tendinitis and impingement.
Studies have proven these problems can be due to the entry portal of the nail. Indeed, it is inserted through the supra-spinatus tendon, which means an opening of the rotator cuff even if it is closed at the end of the procedure.
But the rotator interval split in the shoulder can allow to insert the nail through it without opening the cuff or damaging the cartilage. It is located between the anterior side of the supra-spinatus tendon and the posterior side of the long part of the biceps.
The aim of the study is to compare the speed of functional recovery according to the entry portal, which are through the rotator cuff or through the rotator interval split, in humeral fractures treated by anterograde nailing.
The cutaneo-muscular approach will be the same in both groups, namely a trans-deltoid approach.
People will be included in the study after an enlightened and signed consent, afterward they will be randomized to one of the two groups.
To evaluate the primary outcome, the Constant Score will be used to measure the kinetic of the recovery.
The secondary outcomes are residual pain (measured by the VAS an evaluation of complications and a radiological review (two different reviewers) to follow the healing and search any side effects, the sick leave and rehabilitation durations.
The patients need to be available for a one-year follow-up. Each assessment will be checked at 21 and 45 days, and at 3, 6 and 12 months after the surgery.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be available for a one year follow-up
- •Patients over 18 and under 70 years old
- •Humeral diaphysis fracture or humeral upper extremity articular fracture (Neer 2,3 or 4), needing to be treated by anterograde nailing.
- •No growth plates
- •Patients covered by the French social security service
- •Patients able to give their enlightened consent and to answer the questions asked for the trial
排除标准
- •Pregmant, breastfeeding or potentially pregmant woman
- •Existing bone disease
- •Polytrauma
- •Other fractures on the same upper limb
- •Pathologic fracture
- •Medical history of surgery on the same shoulder
- •Contra-indication to the surgery or the anesthesia
- •Infection on the operating site
- •Axillary nerve palsy
- •Deltoid dysfunction
结局指标
主要结局
Speed of functional recovery
时间窗: Month 12
Measured by the objective Constant score (absolute and weighted values), which includes an evaluation of the pain, level of daily activities, use of the hand, range of motion and strength. The collected data will allow us to draw a diagram to compare the speed of recovery. Its values are between 0 (bad) and 100 (good)
次要结局
- Intensity of Pain(Month 12)
- Duration of the rehabilitation(month 12)
- Surgery datas(during the surgery (Day 0))
- haemoglobin levels(during the surgery and immediately after (Day 0))
- Radiological evolution(Month 12)
- Quick Dash(Month 12)
- Simple shoulder test (SST)(Month 12)
- Complications assessment(Month 12)
- Duration of the sick leave(Month 12)