Prospective Randomized Controlled Trial to Compare Bruner Incision With Modified Midlateral Bruner Incision for Flexor Tendon Repair
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 主要终点
- pain with exercise
研究概览
简要总结
Flexor tendons injuries in the fingers are common and often require surgery. During surgery, the surgeon needs to make an incision in the skin on the inside of the finger to access the damaged tendon.
A comparison will be done between two types of skin incisions in the fingers:
- Bruner zig-zag incision
- modified Bruner midlateral zig-zag incision
Research questions:
- Is there a difference in pain between the types of incisions?
- Is there a difference in swelling between the types of incisions?
- Does the type of incision affect the final result in term of motion?
Patients who will undergo surgery for a flexor tendon injury in a finger will be asked to participate and be randomized to one type of skin incision. All other parts of the surgery will be carried out as usual.
An occupational therapist and nurse will measure swelling and motion. The participant will report pain on a daily basis.
The results for pain, swelling, motion in the fingers and sensibility in the fingers will be statistically compared between the two types of incisions on a group level.
The results of this study may lead to guidelines for skin incisions in acute flexor tendon repair, allowing patients to experience less pain and swelling. This may facilitate the rehabilitation program and improve the final functional outcome.
详细描述
Background and Purpose Tendon injuries are a common type of hand trauma, with flexor tendon injuries most often occurring in zone II. Careful surgical technique followed by early, intensive mobilization under the supervision of a hand therapist is of utmost importance. The traditional Bruner incision, a zig-zag incision, provides wide exposure. However, it also causes extensive soft tissue trauma, leading to swelling and pain, which in turn may reduce adherence to hand rehabilitation protocols. The modified Bruner incision is an alternative approach in which the incision is placed along the lateral side of the finger and slightly curved volarly toward the midpoint between the flexion creases, without crossing the volar midline. This approach provides adequate exposure of the flexor tendon and the digital neurovascular structures with less dissection. Clinical experience suggests that the modified Bruner incision may result in less swelling and pain, faster wound healing and improved conditions for early mobilization. However, there is currently a lack of studies comparing clinical outcomes between the traditional Bruner incision and the modified Bruner incision.
The aim of this study is to investigate whether there are differences in swelling, pain and functional outcomes between patients undergoing flexor tendon repair using the traditional Bruner incision versus the modified Bruner incision.
Research Questions
In primary repair of zone II flexor tendon injuries:
- Do patients treated with a modified Bruner incision experience less postoperative pain during the first three months after surgery?
- Do fingers operated on using a modified Bruner incision demonstrate reduced swelling during the first three postoperative months?
- Do fingers repaired with a modified Bruner incision show improved range of motion during the first three postoperative months?
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •flexor tendon injury in the hand in zone 2
排除标准
- •complex injuries with fracture and/or skin defect
- •previous injury with functional deficit of the finger or the contralateral control finger
- •incapable to follow the training protocol for flexor tendon injuries
- •not proficient in swedish or english language
- •active substance abuse
研究组 & 干预措施
Bruner
Traditional Bruner skin incision
干预措施: Skin incision for flexor tendon repair (Procedure)
Modified Bruner
Modified midlateral Bruner skin incision
干预措施: Skin incision for flexor tendon repair (Procedure)
结局指标
主要结局
pain with exercise
时间窗: from day 3 after surgery, daily until 3 months after surgery
Visual Analogue scale from 0 to 10. 0 = is no pain at all; 10 = the worst pain
次要结局
- pain at rest(from day 3 after surgery until 3 months after surgery)
- skin healing(at 2, 3, 4, weeks)
研究者
Anders Bjorkman
Professor in Hand Surgery
Sahlgrenska University Hospital