The Effects of a Stainless Steel Suture MGH Flexor Tendon Repair Coupled With Early Aggressive Range of Motion Rehabilitation: a Randomized Controlled Trial
2011년 4월 28일 업데이트: 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.
연구 개요
상태
알려지지 않은
상세 설명
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.
연구 유형
중재적
등록 (예상)
24
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Manitoba
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Winnipeg, Manitoba, 캐나다, R3A 1R9
- Health Sciences Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
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활성 비교기: 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.
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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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Return to work
기간: Post-operative weeks 1, 2, 4, 6 and 12
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At each clinic visit at the above mentioned time periods, the clinician will ask the patient if they have returned to work (if applicable)
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Post-operative weeks 1, 2, 4, 6 and 12
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Finger joint range of motion (PIP, DIP, MCP)
기간: Post-operative weeks 1, 2, 4, 6 and 12
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Compliance with therapy
기간: Post-operative weeks 1, 2, 4, 6 and 12
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At each clinic and occupational therapy visit, an assessor will ask the patient if they have been compliant with therapy
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Post-operative weeks 1, 2, 4, 6 and 12
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Rupture
기간: Post-operative weeks 1, 2, 4, 6 and 12
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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
기간: 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
기간: 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
기간: Post-operative weeks 1, 2, 4, 6 and 12
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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
기간: Post-operative weeks 1, 2, 4, 6 and 12
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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)
기간: Post-operative weeks 1, 2, 4, 6 and 12
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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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2011년 6월 1일
기본 완료 (예상)
2012년 6월 1일
연구 완료 (예상)
2013년 6월 1일
연구 등록 날짜
최초 제출
2011년 4월 28일
QC 기준을 충족하는 최초 제출
2011년 4월 28일
처음 게시됨 (추정)
2011년 4월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2011년 4월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2011년 4월 28일
마지막으로 확인됨
2011년 2월 1일
추가 정보
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