Sensor Controlled Compliance Evaluation of Compressive Elastic Stockings (SENSCOMP)
"Sensor Controlled Compliance Evaluation of Compressive Elastic Stockings Treatment in Patients After Elective Foot and Ankle Surgery" A Prospective, Randomized and Controlled Cohort Study
調査の概要
詳細な説明
Pain and swelling are typical sequelae following surgical procedures at the foot and ankle. While it is known that compressive stockings treatment decreases swelling and improves overall ankle function and quality of life in patients after ankle fracture, the investigators hypothesize that compressive stockings could also ameliorate functional outcome and quality of life in patients after elective orthopedic foot and ankle surgery.
Reduced compliance in wearing compressive stockings after foot and ankle surgery might probably be a limiting factor of this postoperative adjuvant compressive therapy. Therefore the investigators want to evaluate patient´s compliance by using an electronic chip device to monitor wearing behavior.
All patients who will be operated on their feet and ankle are randomized and blindly assigned into either the compressive or control-group. Each group consists of 80 patients (160 patients in total). The compression group includes patients who receive postoperative compression stockings. The control group does not receive any stockings. Regular checks at 6 weeks and 12 weeks postoperatively will be performed in order to assess the following parameters:
- Foot and Ankle Scores
- Pain
2. Swelling of the foot and lower limb 3. Wearing compliance by electronically recorded wearing time.
The Information about the implanted sensor, which records the stockings wearing time will be given to the patients after the compressive stockings therapy (6 weeks), so that the patients are not influenced by the fact, that their wearing behaviour had been measured.
After this information, the patients decide if the sensor information may be evaluated by the study team or not.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Zürich、スイス、8008
- Universtiy Hospital Balgrist
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion criteria:
- all patients with a signed informed consent
- all patients, who underwent hindfoot and middlefoot surgery
Exclusion criteria:
- patients with a externe Fixateur.
- patients with contraindication for the use of compressive stockings
- patients with severe General disease (cancer, rheumatoider Arthritis)
研究計画
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Compressive Stockings group
Patients with compressive stockings at the operated foot for 4 weeks
|
After hindfoot and middlefoot surgery the patients from the Intervention Group will be treated with compressive stockings the removal of the suture. That means from the end of week 2 until the end of week 6 after surgery. Additionally the patients wearing behaviour is monitored by a electronic sensor, which is implanted in the patient´s stocking. |
|
介入なし：No compressive stockings group
Patients with no compressive stockings at the operated foot
|
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 |
|---|---|---|
|
Wearing Compliance
時間枠：6 weeks postoperatively
|
With a sensor the wearing time in hours/day is monitored.
Patients will be informed about the sensor at the 6 week follow up.
They will be asked if the study Team is allowed to read the monitored wearing time.
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6 weeks postoperatively
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain
時間枠：12 weeks postoperatively
|
Pain assessed in a visual analog scale ranging from 0-10 (0= no pain, 10= worst pain)
|
12 weeks postoperatively
|
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worker´s compensation
時間枠：12 weeks postoperatively
|
% of ability to work the peroperative performed occupation.
|
12 weeks postoperatively
|
|
pain killer use
時間枠：12 weeks postoperatively
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How many pills per day the patients require for the pain after surgery.
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12 weeks postoperatively
|
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AOFAS
時間枠：12 weeks postoperatively
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American Orthopedic Foot and Ankle Score
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12 weeks postoperatively
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Swelling
時間枠：12 weeks postoperatively
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Foot and ankle swelling measured in cm at defined Areas of the foot and ankle
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12 weeks postoperatively
|
協力者と研究者
捜査官
- 主任研究者：Stephan Wirth, Dr. med.、Balgrist University Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- W568
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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