跳至主要内容
临床试验/NCT01344980
NCT01344980Unknown2 期

A Pilot Study of a Randomized Controlled Trial Comparing Stainless Steel Suture Repair Coupled With Aggressive Post-Operative Rehabilitation to Polypropylene Suture Paired With Active Range of Motion Rehabilitation

University of Manitoba2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
2 期
入组人数
24
试验地点
2
主要终点
Return to work

研究概览

简要总结

The investigators are comparing the combination of a stainless steel repair and aggressive early active range of motion rehabilitation protocol for flexor tendon lacerations in the hand with a current, accepted treatment offered at our institution. Outcomes to be assessed will be time to return to work, joint range of motion in the injured fingers, and any potential complications that may arise (ex: surgical infections or repair rupture). All proposed treatments included in this study are currently being offered at our institution, but not in a randomized fashion.

详细描述

This study will serve as a pilot-study for a future randomized controlled trial. Adult patients with zone 2 flexor tendon lacerations of the hand (anatomically from the A1 pulley of the hand to the insertion of the flexor digitorum superficialis) who have presented to the emergency room acutely (within 1 week of injury) at the Health Sciences Center in Winnipeg will be asked for their participation in this study. Consent will be obtained by a plastic surgery resident either in the emergency room or in the plastic surgency emergency decanting clinic. The investigators will include twenty-four patients in the study, randomized into one of two treatment groups (groups A and B) by block randomization. Randomization will be done once patients agree to participate in the study. All patients will be booked for surgery on the emergency slate. Each treatment group will be treated by a single surgeon who is an expert at treatment of these injuries. Group A patients will have their laceration(s) repaired using a modified Becker repair technique using stainless steel suture in the operating room, and then will proceed to undergo an aggressive early active range of motion rehabilitation administered by the hand therapists at HSC. Group B patients will undergo a double-locking loop suture repair using polypropylene. They will then undergo a less aggressive active range of motion rehabilitation protocol which is currently offered to patients at our center. Follow-up will occur in plastic surgery outpatient clinic at post-operative weeks 1, 2, 4, 6 and 12. Follow-up with hand therapy will be at the discretion of the therapists. At each visit with hand therapy, joint range of motion will be assessed at the PIP and DIP joints in the affected fingers. Final range of motion will be assessed using the Strickland system for evaluating flexor tendon surgery outcomes, and will be done by a blinded hand therapist.

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
Triple (Participant, Investigator, Outcomes Assessor)

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

入选标准

  • living in Winnipeg, Manitoba
  • zone II flexor tendon lacerations in a single finger
  • able to consent to and comply with surgery

排除标准

  • crush injuries
  • vascular injuries requiring re-vascularization
  • fractures
  • infection
  • prior hand injury requiring surgery

结局指标

主要结局

Return to work

时间窗: Post-operative weeks 1, 2, 4, 6 and 12

At each clinic visit at the above mentioned time periods, the clinician will ask the patient if they have returned to work (if applicable)

Finger joint range of motion (PIP, DIP, MCP)

时间窗: Post-operative weeks 1, 2, 4, 6 and 12

At each clinic / occupational therapy visit, a blinded assessor will determine the total range of motion of the finger DIP, PIP and MCP joints

次要结局

  • Compliance with therapy(Post-operative weeks 1, 2, 4, 6 and 12)
  • Rupture(Post-operative weeks 1, 2, 4, 6 and 12)
  • Infection(Post-operative weeks 1, 2, 4, 6 and 12)
  • Attendance with follow-up clinic and occupational therapy(Post-operative weeks 1, 2, 4, 6 and 12)
  • Use of oral analgesics(Post-operative weeks 1, 2, 4, 6 and 12)
  • Oral antibiotic usage(Post-operative weeks 1, 2, 4, 6 and 12)
  • Wound dehiscence (breakdown)(Post-operative weeks 1, 2, 4, 6 and 12)
  • Use of occupational therapy adjunctive treatments(Post-operative weeks 1, 2, 4, 6 and 12)

研究者

申办方类型
Other

研究点 (2)

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