Total Knee Arthroplasty - Accelerated Recovery Without Tourniquet
キーワード
概要
説明
Design
Patients being able to participate in this study all have to fulfill the given inclusion criteria:
- Patients with symptomatic and radiographic verified knee symptoms, selected for primary unilateral total knee joint replacement (TKA)
- Age 50 and above (not older than 85)
- BMI < 35 and height >160 cm
- No severe cardiovascular conditions
- No previously knee surgery done in the same knee
- Oral and written acceptance
A group concerning 2 x 30 patients will be randomized into two groups. Either an intervention group, with absence of tourniquet or a control group with tourniquet. Which group they will belong to, is blinded to patient and surgeon until they reach operation room. The operation will be performed as usual, but with exception of two additional procedures. During operation small spheric tantalum pellets are placed around the prosthesis. Furthermore patients are prepared for microdialysis, which contain placement of 3 catheters: one in each thigh and one subcutaneously in the abdomen.
Microdialysis is a unique technique to monitor the chemistry of the extracellular space in living tissue. It is primarily used for In Vivo determinations of endogenous metabolites, thus serving as an indicator for ischemia.
RSA is precision radiology where the small pellets are visual on x-ray. Using computer a 3D image is created and the pellets serve as markers. These markers will be measured every 6 months showing whether a possible migration of the prosthesis is occurring and thereby indicating a loosening.
Out-patient treatment Patients will among other things be followed by clinical functional scores, registration of analgetica use, conventional X-ray and RSA In the long run the perspective is that surgery concerning knee replacements will be conducted without the use of tourniquet and thereby reducing the pain of the patients without compromising the end result of the operation, namely the fixation of the prosthesis.
Permissions approved by the Regional Committee on Biomedical Research Ethics, Region of Northern Jutland and Danish Data Protection Agency.
日付
| 最終確認済み: | 12/31/2014 |
| 最初に提出された: | 01/13/2011 |
| 提出された推定登録数: | 03/01/2011 |
| 最初の投稿: | 03/03/2011 |
| 最終更新が送信されました: | 01/28/2015 |
| 最終更新日: | 01/29/2015 |
| 実際の研究開始日: | 02/28/2011 |
| 一次完了予定日: | 04/30/2014 |
| 研究完了予定日: | 04/30/2014 |
状態または病気
介入/治療
Procedure: Total Knee Arthroplasty
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Active Comparator: With Tourniquet Total Knee Arthroplasty. Surgery performed during use of a tourniquet. | |
| Experimental: Without Tourniquet Total Knee Arthroplasty. Surgery performed without use of a tourniquet. |
適格基準
| 研究の対象となる年齢 | 50 Years に 50 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - Patients with symptomatic and radiographic verified knee symptoms, selected for primary unilateral total knee joint replacement (TKR) - Age 50 and above (not older than 85) - BMI < 35 and height >160 cm - No severe cardiovascular conditions - No previously knee surgery done in the same knee - Oral and written acceptance Exclusion Criteria: - Severe obesity - rheumatic diseases - Absence of pulse in foot - Diabetes - Previous operation in concerning knee - Lack of informed consent or ability to read / understand Danish |
結果
主な結果の測定
1. Determine whether prosthesis fixation, measured by RSA, is affected by tourniquet use. [1.Feb 2011 -1 jan 2013]
二次的な結果の測定
1. To investigate the advantages and disadvantages of tourniquet use, including whether not using a tourniquet reduces pain, facilitates mobilisation and recovery, and shortens length of stay. [1.feb 2011 - 1.jan 2013]
