Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Strength, Functionality and Post Operative Complications
The aim of the present study is to explore the most efficient surgical approach in total hip replacement in short and long term when concerning strength, functionality and postoperative complications.
The objective is to register muscular strength, hip joint functionality/mobilisation and complications after total hip arthroplasty (THA) performed by two minimal invasive/incision surgeries (MIS) versus the traditionally lateral approach.
The primary working hypothesis is that due to a minimal dissection and reduced trauma in the muscles, patients will tolerate early hospital discharge better after MIS than after traditional lateral surgery. Patients in the MIS group will also be more active and maintain muscular strength and hip joint functionality/mobilisation better than patients in the lateral group.
調査の概要
詳細な説明
With total hip replacement surgery, the orthopaedic surgeon's aim is not only pain relief for the patient, but also restoration of hip joint biomechanics resulting in a minimal functional deficit and maximal longevity of the implant. It is not exceptional that these patients still experience mild to moderate long-term impairments postoperatively. These impairments include pain, muscle weakness of the hip abductors, contracture of the hip, gait disorders, as well as weakness of hip extensors and flexors. These problems may in turn lead to complications such as joint instability and loosening of the implant. When the lateral surgical approach is used, major concerns after total hip replacement surgery are muscle abductor weakness/atrophy, tendon defects of the gluteus minimus muscle, and unsuccessful reattachment or denervation of the anterior gluteal flap.
Minimal incision/invasive surgery (MIS) is defined as a surgical approach performed through a short skin and muscle incision to avoid injury to muscles and tendons. Following minimally invasive approach reduced muscle trauma has been found. Moreover clinical outcome improved, as the gluteus medius muscle can be spared more successfully. However, it is debated whether or not the overall results of MIS are superior, or even as good as the traditional hip replacement surgery in terms of component placing and time to revision of the prosthesis.
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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Trondheim、ノルウェー
- St Olavs Hospital
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参加基準
適格基準
就学可能な年齢
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:
- Patients scheduled for THA
- Diagnosis of primary osteoarthritis as the main cause for elective THA
- American Society of Anesthesiologists (ASA) score I, II, and stable III
Exclusion Criteria:
- Musculoskeletal diseases
- Current heart/pulmonary- or malignant diseases likely to influence the physical testing performance.
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:非ランダム化
- 介入モデル:並列代入
- 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 |
---|---|
アクティブコンパレータ:direct lateral
|
Total hip replacement; direct lateral approach
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実験的:minimal invasive
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Total hip replacement; minimal invasive approach
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実験的:modified minimal invasive
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Total hip replacement; modified minimal invasive approach
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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 |
時間枠 |
---|---|
Implant stability
時間枠:2 years
|
2 years
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Implant stability
時間枠:5 years
|
5 years
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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
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。
変形性股関節症の臨床試験
Direct lateralの臨床試験
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Northwest Biotherapeuticsわからない
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Institute of Cancer Research, United KingdomCancer Research UK; University of Manchester; University of Sussex完了
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Yonsei University募集
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Stanford UniversitySanta Clara Valley Medical Center引きこもった
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University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)完了