The CARBO Study (metaCARpal Bone Osteosynthesis)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 552
- 试验地点
- 1
- 主要终点
- Grip strength
研究概览
简要总结
Background Metacarpal shaft fractures account for 30-50% of hand fractures (Karl et al., 2015; Kollitz et al., 2014; van Onselen et al., 2003), with diaphyseal spiral and oblique fractures of the second to fifth ray posing unique challenges due to the risks of shortening and rotational deformities. Current standard care of displaced fractures involves operative fixation.
However, retrospective studies have indicated that nonoperative treatment, involving early mobilization or buddy taping, can achieve outcomes comparable to operative treatment (Daher et al., 2023). There is only one published, with a small sample size, randomized controlled trial (RCT) investigating this issue (Peyronson et al., 2023). This highlights the need for a robust multicenter RCT to address these gaps in evidence.
Aim The aim of this study is to compare the one-year outcomes of non-operative treatment involving immediate unrestricted mobilization versus operative treatment of displaced oblique or spiral diaphyseal metacarpal fractures in adults.
Materials and Methods This is a multicenter, pragmatic, prospective, noninferiority RCT involving 552 adult patients with displaced oblique and/or spiral diaphyseal metacarpal fractures of the second to fifth ray. Participants will be randomized 1:1 to receive either nonoperative treatment with unrestricted mobilization and rehabilitation) or operative treatment (with screw or plate fixation) followed by rehabilitation.
The primary outcome is grip-strength in the injured hand presented in kilograms at one year.
Secondary outcomes include questionnaires, complications, range of motion, patient reported outcome measures, health related quality of life, patient satisfaction, and radiographic healing.
A power calculation proposes a study size of 552 participants to detect a noninferiority margin of 10% in grip strength.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Access to a valid e-mail.
- •Injury within 10 days prior to inclusion.
- •Normal bilateral hand function prior to injury.
- •Ability and willingness to provide written informed consent
- •Single, displaced spiral or oblique diaphyseal fracture of the second to fifth metacarpals with definition of diaphysis as described by AO 2018 (AO/OTA as 77.2-5.2A) (Meinberg et al., 2018).
- •Fracture line length at least twice the diameter of the bone at the level of the fracture.
- •Fractures with at least 2 mm of radiological displacement and/or malrotation of injured finger compared to uninjured side regardless of fracture displacement.
排除标准
- •The patient IS NOT expected to have difficulty adhering to the study protocol (e.g., due to insufficient language proficiency, dementia, substance abuse, or other reasons).
- •The patient DOES NOT have an open fracture (Gustilo-Anderson grade > I) or a pathological fracture.
- •The patient DOES NOT have an ipsilateral fracture of the upper extremity, polytrauma, or generalized joint dysfunction (e.g., rheumatoid arthritis).
研究组 & 干预措施
Non-operative with early mobilization
Participants randomized to the nonoperative group will receive immediate unrestricted mobilization, with optional buddy taping or removable splinting for comfort. Closed reduction will not be attempted. Rehabilitation protocol with early mobilization will be standardized across study centers with printed standardized information to patients and rehabilitation staff.
干预措施: Non-operative treatment with early mobilization (Procedure)
Operative
Participants randomized to the operative group will undergo open reduction and internal fixation (ORIF) of the MSF. Peri-operative antibiotic prophylaxis will be administered according to local guidelines. The surgical approach and fixation method (e.g. compression screws and/or plate, not K-wires) will be at the discretion of the treating surgeon, following standard surgical principles. Postoperative immobilisation will adhere to surgeons' preference but not exceed two weeks fixation.
干预措施: Operative treatment (Procedure)
结局指标
主要结局
Grip strength
时间窗: From enrollment to the end of follow-up at 12 months
The primary outcome is grip-strength measured in the injured hand using a JAMAR dynamometer at 12 months and presented in kilograms. Measurement method will follow the technical description presented in the HAKIR manual (HAKIR, 2023).
次要结局
- Complications(From enrollment to the end of follow-up at 12 months)
- Pain in injured hand NRS(From enrollment to the end of follow-up at 12 months)
- Rotational deformity(12 months)
- PROM - patient rated outcome measure(6, 12 weeks, 12 months)
- Range of motion(6, 12 weeks, 12 months)
- Pinch grip strength(12 weeks, 12 months)
- Radiographic shortening(12 months)
- Radiographic healing(12 weeks, 12 months)
- Sick leave duration(12 months)
- Patient satisfaction(From enrollment to the end of follow-up at 12 months)
- Quality of life measured by PROM(From enrollment to the end of follow-up at 12 months)
- Quality of life measured by SF-12(From enrollment to the end of follow-up at 12 months)
研究者
Cecilia Mellstrand Navarro
MD PhD
Karolinska Institutet