Arthroscopic Versus Open Cancellous Bone Grafting for Scaphoid Delayed/Non-union in Adults: Study Protocol for a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Time to Union
研究概览
简要总结
Single site, prospective, observer-blinded randomized controlled trial. Eighty-eight patients aged 18-68 years with scaphoid delayed/non-union, will be randomized, 1:1, to either open iliac crest cancellous graft reconstruction or arthroscopic assisted distal radius cancellous chips graft reconstruction. All Danish citizens, referred to the orthopedic department, Copenhagen University Hospital in Gentofte with scaphoid delayed/nonunion will be offered participation in the trial. Exclusion criteria are: Associated fracture in the hand/upper extremity, previous failed surgical treatment for scaphoid delayed/nonunion, stage 2 SNAC or above, avascular necrosis of the proximal pole and gross deformity.
Patients are stratified for smoking habits, proximal pole involvement, and displacement of >/<2mm. The primary outcome is time to union, measured with repeated CT scans at 2-week intervals from 6 to 16 weeks postoperatively. Secondary outcomes are Quick disabilities of the Arm, Shoulder and Hand (Q-DASH), Visual Analogue scale (VAS), donor site morbidity, union rate, restoration of scaphoid deformity, range of motion, key-pinch, grip strength, EQ5D-5L, patient satisfaction, complications, and revision surgery. Patients are examined before the operation and 1.5, 3, 6, 12 and 24 month after the operation. Online follow-up 5 and 10 years after surgery are performed.
详细描述
A scaphoid fracture is the most common injury to the carpal bones. The incidence is 107-151/100.000 per year and fractures are predominantly sustained by males in their twenties. Scaphoid non-union is defined as a lack of healing 6 months after injury and develops in 5-25% of cases after non-operative treatment. Delayed union is defined as incomplete healing 2-6 months after injury. However, some potential for a union probably exists, especially in nondisplaced fractures, otherwise this condition is associated with a transition into a persistent non-union. The risk of non-union increases with delayed diagnosis and treatment, displaced fractures, proximal pole fractures, smoking, poor vascularity, and advancing age.
The scaphoid is primarily covered with cartilage and has a retrograde blood supply. The dorsal branch of the radial artery accounts for 80% and a separate volar branch for 20 % of the extramedullary blood supply. The proximal pole is only supplied by the intramedullary flow. Compromised blood supply can explain the potential of non-union and avascular necrosis of the proximal pole. The healing process can be complicated by volar angulation of the fracture leading to humpback deformity. This will disrupt carpal kinematics, and result in lunate instability and dorsal intercalated segment instability (DISI). Untreated scaphoid non-union can lead to degenerative changes, called scaphoid non-union advanced collapse (SNAC), and irreversible impairment such as pain and altered hand function.
X-ray is commonly applied to evaluate the scaphoid, although CT scans are reportedly superior in terms of displacement, angulation and union[9]. Different measurements to describe the angulation and deformity of the scaphoid are suggested. The Height length ratio (HLR) and dorsal cortical angle (DCA) are found to be the most reliable measurements.
Surgical treatment of scaphoid delayed/non-union is technically demanding and often results in a long period with a supportive bandage until union is established. Current treatment strategies for delayed union and non-union include vascularized or non-vascularized bone graft with internal fixation. Kirchner wires or screws have been the gold standard for fixation.
Arthroscopic reconstruction with C chips and internal fixation is predominantly applied in delayed union and stable non-union. The advantages of arthroscopy include thorough wrist assessment, evaluation of concomitant ligamentous injury and minimal trauma to the ligament structures, joint capsule, and the tenuous blood supply.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
observer-blinded RCT, union is assessed by a blinded musculoskeletal radiologist. QDASH is a patient-reported survey, without the involvement of surgeons or research staff. Other secondary outcomes will be measured by an independent observer. The study will not be blinded to the operating theatre staff, surgeons, physiotherapists, or patients.
入排标准
- 年龄范围
- 18 Years 至 68 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-68 years.
- •A scaphoid fracture without healing 2-6 months since fracture (delayed union) for cases with either displacement >1mm or comminution and failed non-operative treatment.
- •Scaphoid fracture without healing >6 months since fracture (non-union) regardless of displacement, comminution and if previous non-operative treatment has been tried.
排除标准
- •Open fractures
- •Associated trans-scaphoid perilunate dislocation.
- •Associated fracture in the hand/upper extremity.
- •Previous failed surgical treatment for scaphoid delayed/non-union.
- •Stage 2 SNAC or above.
- •Avascular necrosis of the proximal pole as evaluated with MRI and absence of punctate bleeding intraoperatively.
- •Patients with gross humpback deformity of HLR >0.75 and/or DCA <70⁰.
- •Patients unable to understand instructions in Danish, complete the rehabilitation protocol, or answering the questionnaires because of physical or cognitive impairment, as evaluated by the surgeon at the first visit.
结局指标
主要结局
Time to Union
时间窗: 6-16 weeks postoperative in 2 weeks intervals. If unions is not achieved a CT will be made 26 weeks postoperatively. If union is not achieved at that point, the patient will be presented for another treatment modality
Assessed with CT-scans. Union is proclaimed if at least 50% bone bridging is recorded together with absence of pain in the clinical examination
次要结局
- Pain (VAS)(Preoperatively, 1.5, 3, 6, 12, 24, 60, and 120 months postoperative)
- Union rate(6-16 weeks postoperative. If unions is not achieved a CT will be made 26 weeks postoperatively)
- The Quick Disability of the Arm, Shoulder, and Hand (Q-DASH)(Preoperatively, 1.5 md, 3md, 6md, 12md, 24md, 60md, and 120 months postoperative)
- Donor site morbidity(Preoperatively, 1.5, 3, 6, 12, 24, 60, and 120 months postoperative)
- Grip strength(Preoperatively, 1.5, 3, 6, 12, and 24 months postoperative)
- Key pinch(Preoperatively, 1.5, 3, 6, 12, 24, 60, and 120 months postoperative)
- Correction of deformity(Before surgery compared to CT-scan with >50% bone bridging.)
研究者
Morten Kjaer
Medical doctor, PhD student
Herlev and Gentofte Hospital
