Minimally Invasive Retrograde Carpal Tunnel Release Using the KeriKnife™ Under Direct Visualization (KERIVIEW)
Carpal tunnel syndrome surgery is one of the most common procedures in orthopedic and trauma surgery. Traditionally performed via an open incision or endoscopically, this procedure aims to decompress the median nerve by cutting the transverse carpal ligament. However, these techniques, while effective, have certain limitations, particularly in terms of postoperative pain, wound healing, functional recovery, and the risk of complications (hematoma or nerve injury).
Recent advances have made it possible to perform median nerve release using minimally invasive surgery to improve patient comfort and speed up recovery. In this context, the use of devices designed for the controlled sectioning of the transverse carpal ligament represents a technical advancement of interest.
This minimally invasive technique is also supported by anatomical studies demonstrating the safety and efficacy of the single-incision approach at the wrist.
To date, clinical data regarding the use of the KeriKnife™ under visual guidance are limited. It therefore seems appropriate to conduct a prospective study aimed at documenting the feasibility, safety, and functional outcomes of this technique under standardized conditions of use.
This project is part of a pragmatic clinical evaluation approach designed to generate objective data on an existing practice in order to assess its safety and short- and medium-term functional outcomes.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patients over the age of 18 with severe carpal tunnel syndrome as determined by electromyography
- No other concomitant condition affecting the hand
- Surgical indication for median nerve release
- Have signed an informed consent form
- Be enrolled in a social security program or be a beneficiary of such a program
Exclusion Criteria:
- Contraindications to carpal tunnel surgery
- Presence of a concomitant condition affecting the hand to be operated on
- Secondary carpal tunnel syndrome (e.g., tumor, synovial cyst, anatomical malformation, post-traumatic sequelae)
- History of carpal tunnel surgery on the affected hand
- Associated neurological conditions (peripheral neuropathies, Amyotrophic Lateral Sclerosis, Charcot-Marie-Tooth, etc.)
- Coagulation disorders or anticoagulant therapy that cannot be discontinued
- Patients who are unable to give informed consent or cannot return for scheduled follow-up visits as required by the protocol
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：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Patients who underwent carpal tunnel surgery with the KeriKnife™ under visual guidance
|
Complete minimally invasive carpal tunnel release using the KeriKnife™ under visual guidance
|
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 |
|---|---|---|
|
Composite endpoint that includes the technical success of the procedure and the absence of major complications related to the procedure at 30 days to evaluate the safety and feasibility of the intervention with the KeriKnife™ under visual guidance
時間枠：Day 30
|
The safety and feasibility of minimally invasive carpal tunnel release performed with the KeriKnife™ under visual guidance, will be evaluated using a composite endpoint that includes the technical success of the procedure and the absence of major complications related to the procedure at 30 days.
Iatrogenic nerve injury Vascular injury Tendon injury Compressive hematoma requiring therapeutic intervention Surgical site infection requiring invasive treatment or reoperation Severe algodystrophy Reintervention related to the initial procedure within 30 days postoperatively |
Day 30
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
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。