The Effects of a Stainless Steel Suture MGH Flexor Tendon Repair Coupled With Early Aggressive Range of Motion Rehabilitation: a Randomized Controlled Trial
2011年4月28日 更新者：University of Manitoba
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
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.
研究概览
地位
未知
条件
详细说明
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.
研究类型
介入性
注册 (预期的)
24
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Manitoba
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Winnipeg、Manitoba、加拿大、R3A 1R9
- Health Sciences Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- adults
- living in Winnipeg, Manitoba
- zone II flexor tendon lacerations in a single finger
- able to consent to and comply with surgery
Exclusion Criteria:
- crush injuries
- vascular injuries requiring re-vascularization
- fractures
- infection
- prior hand injury requiring surgery
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Stainless steel MGH
Patients in this study arm will have their flexor tendon laceration repaired using stainless steel suture (size 3-0) in an MGH repair technique.
They will then undergo aggressive early active range of motion rehabilitation post-operatively.
|
Stainless steel suture material will be used (size 3-0) in an MGH repair technique
Patients undergoing this form of rehabilitation will have their splints discontinued at 4 weeks and ideally will be back at work at normal duties by 6 weeks.
This rehabilitation uses more movement at a faster progression than other early active range of motion protocols.
|
|
有源比较器：Polypropylene DOLL
Patients in this study arm will have their flexor tendon laceration repaired using polypropylene suture (size 3-0) in a double-locking loop repair technique.
They will then undergo aggressive early active range of motion rehabilitation post-operatively.
|
Polypropylene suture (size 3-0) will be used in a double-locking loop repair technique
Patients undergoing this form of rehabilitation will have their splints discontinued at 6 weeks and ideally will be back at work at normal duties by 10-12 weeks.
This rehabilitation uses less movement at a slower progression than the early AROM rehabilitation protocol specified in the experimental group
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Return to work
大体时间：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)
|
Post-operative weeks 1, 2, 4, 6 and 12
|
|
Finger joint range of motion (PIP, DIP, MCP)
大体时间：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
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Post-operative weeks 1, 2, 4, 6 and 12
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Compliance with therapy
大体时间：Post-operative weeks 1, 2, 4, 6 and 12
|
At each clinic and occupational therapy visit, an assessor will ask the patient if they have been compliant with therapy
|
Post-operative weeks 1, 2, 4, 6 and 12
|
|
Rupture
大体时间：Post-operative weeks 1, 2, 4, 6 and 12
|
At each follow-up visit with the clinician or occupational therapist, the presence of a rupture will be assessed for clinically.
Alternatively this will be recorded if the patient presents to the emergency room with a flexor tendon rupture
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Post-operative weeks 1, 2, 4, 6 and 12
|
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Infection
大体时间：Post-operative weeks 1, 2, 4, 6 and 12
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At each clinic visit, the patient will be assessed clinically for the presence or absence of an infection.
This will also be noted if the patient presents to the emergency room.
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Post-operative weeks 1, 2, 4, 6 and 12
|
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Attendance with follow-up clinic and occupational therapy
大体时间：Post-operative weeks 1, 2, 4, 6 and 12
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The patient's attendance will be determined at each clinic or occupational therapy visit.
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Post-operative weeks 1, 2, 4, 6 and 12
|
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Use of oral analgesics
大体时间：Post-operative weeks 1, 2, 4, 6 and 12
|
At each clinic visit, the patient will be asked if they are still using oral analgesics
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Post-operative weeks 1, 2, 4, 6 and 12
|
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Oral antibiotic usage
大体时间：Post-operative weeks 1, 2, 4, 6 and 12
|
At each clinic visit, the patient will be asked if they are using oral antibiotics.
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Post-operative weeks 1, 2, 4, 6 and 12
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Wound dehiscence (breakdown)
大体时间：Post-operative weeks 1, 2, 4, 6 and 12
|
At each clinic and occupational therapy visit, the patient will be assessed to determine if a wound dehiscence (breakdown) has occurred.
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Post-operative weeks 1, 2, 4, 6 and 12
|
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Use of occupational therapy adjunctive treatments
大体时间：Post-operative weeks 1, 2, 4, 6 and 12
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At each occupational therapy visit, it will be recorded that they are either using or not using occupational therapy adjunctive treatments (ex: coban tape, ultrasound or electrical stimulation)
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Post-operative weeks 1, 2, 4, 6 and 12
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年6月1日
初级完成 (预期的)
2012年6月1日
研究完成 (预期的)
2013年6月1日
研究注册日期
首次提交
2011年4月28日
首先提交符合 QC 标准的
2011年4月28日
首次发布 (估计)
2011年4月29日
研究记录更新
最后更新发布 (估计)
2011年4月29日
上次提交的符合 QC 标准的更新
2011年4月28日
最后验证
2011年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.