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.
調査の概要
状態
わからない
条件
詳細な説明
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.
研究の種類
介入
入学 (予想される)
24
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Manitoba
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Winnipeg、Manitoba、カナダ、R3A 1R9
- Health Sciences Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～70年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
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アクティブコンパレータ：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
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Return to work
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Compliance with therapy
時間枠：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
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Post-operative weeks 1, 2, 4, 6 and 12
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Rupture
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年6月1日
一次修了 (予想される)
2012年6月1日
研究の完了 (予想される)
2013年6月1日
試験登録日
最初に提出
2011年4月28日
QC基準を満たした最初の提出物
2011年4月28日
最初の投稿 (見積もり)
2011年4月29日
学習記録の更新
投稿された最後の更新 (見積もり)
2011年4月29日
QC基準を満たした最後の更新が送信されました
2011年4月28日
最終確認日
2011年2月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Stainless steel sutureの臨床試験
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Vesteck, Inc.Prince of Wales Hospital, Sydney募集