Pronator Quadratus Repair After Volar Plating of Distal Radius Fractures or Not? - Results of a Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Isometric forearm pronation strength (N)
研究概览
简要总结
Investigation of the influence of the pronator quadratus (PQ) muscle repair following volar plate fixation of distal radius fractures with regard to the forearm pronation strength. During the early recovery period of 3 months an improvement of pronation strength and functional scorings was hypothesized for the PQ repair when compared to no repair.
Randomization of the patients in two groups ( PQ repair and no repair) and follow-up examinations after 6 and 12 weeks included bilateral isometric pronation strength measurement, range of motion, the QuickDASH and the Mayo-Wrist-Score, and a visual analogue scale (VAS)
详细描述
Investigation of the influence of the pronator quadratus (PQ) muscle repair following volar plate fixation of distal radius fractures with special regards to the forearm pronation strength. During the early recovery period of 3 months an improvement of pronation strength and functional scorings was hypothesized for the PQ repair when compared to no repair.
Therefore the patients are randomized to group A = PQ repair and group B = no repair. Follow-up examinations after 6 and 12 weeks are scheduled included bilateral isometric pronation strength measurement, range of motion, the QuickDASH and the Mayo-Wrist-Score, and a visual analogue scale (VAS)
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •isolated, closed fractures of the distal radius
- •fractures type A2 to B2 according to the AO fracture classification system
- •primary volar locking plate osteosynthesis within 7 days after trauma
排除标准
- •concomitant fractures of the affected upper extremity
- •intra-articular distal radius fractures ( type C)
- •concomitant neurovascular injuries
- •preexisting neurological illnesses
- •initial external fixation
研究组 & 干预措施
PQ (Pronator quadraus) repair
Following volar plate osteosynthesis the pronator quadratus muscle is sutured with 3 to 5 U-shaped stitches using a polyfilament absorbable synthetic suture.
干预措施: Pronator quadratus repair (Procedure)
No PQ repair
Following volar plate osteosynthesis the pronator quadratus muscle is placed in its anatomical position without suture repair.
结局指标
主要结局
Isometric forearm pronation strength (N)
时间窗: 12 weeks postoperative
Measurement of the isometric forearm pronation strength (N) using the IsoForce-Control EVO 2 dynamometer (MDS AG, Oberburg, Switzerland)
Isometric forearm pronation strength (N)
时间窗: 6 weeks postoperative
Measurement of the isometric forearm pronation strength (N) using the IsoForce-Control EVO 2 dynamometer (MDS AG, Oberburg, Switzerland)
次要结局
- Quick DASH Score (Patient-reported evaluation score for disabilities of the arm, shoulder and hand)(12 weeks postoperative)
- Visual analogue scale (VAS)(12 weeks postoperative)
- Mayo-Wrist-Score (Physician-based evaluation score of the wrist function)(12 weeks postoperative)
- Assessment of the bilateral wrist motion (AO neutral-0-method)(12 weeks postoperative)
- Quick DASH Score (Patient-reported evaluation score for disabilities of the arm, shoulder and hand)(6 weeks postoperative)
- Visual analogue scale (VAS)(6 weeks postoperative)
- Mayo-Wrist-Score (Physician-based evaluation score of the wrist function)(6 weeks postoperative)
- Assessment of the bilateral wrist motion (AO neutral-0-method)(6 weeks postoperative)