Role of Autologous Platelet Rich Plasma in Total Knee Arthroplasty (PRPTKA2012)
Efficacy of Autologous Platelet Rich Plasma on Blood Loss, Pain, Wound Healing and Functional Outcome After Total Knee Arthroplasty by a Single Surgeon A Randomized, Prospective, Controlled, Double-blinded Study
調査の概要
詳細な説明
Age, sex and BMI-matched patients who had unilateral or bilateral arthritis of the knee with similar deformity and preoperative range of motion were enrolled for this prospective randomized controlled double blinded clinical trial. The study was approved by the institutional review board, and all patients provided written informed consent to participate in it. Inclusion criteria were patient of either sex who underwent primary unilateral or bilateral surgery or the first surgery of a staged bilateral total knee replacement where the second stage was at least 6 weeks later and those who were willing and able to return for follow-up over at least a six month postoperative period. Patients with preoperative haemoglobin less than 10g/dl and with bleeding disorder were excluded from the study. Two Groups were assigned: 1) APG group and 2) Control group.
Demographic data of the patient was recorded. All routine investigations were carried out and the results were noted. Preoperative haemoglobin, range of motion, WOMAC8 scores and KSS9 scores were noted. Standard knee radiographs i.e. weight bearing anteroposterior and lateral views in 30 degree flexion were taken. Patients were randomly allocated to platelet gel group and control group using opaque envelope method which was opened on the day of surgery.
Pain was measured daily using VAS scale which consisted of markings from 1 to 10. Number of tramadol injections given was also noted. Hemoglobin was measured on the day of surgery and postop day 3 by sysmex automated analyser. Postoperative blood loss was also noted by measuring the weight of soaked dressing and converting it into blood volume. Number of blood units transfused was also recorded. Post operative wound dressing was done on day 3 except in case of soakage. Wound was assessed using wound score form. Similar physiotherapy was advised for both the groups. All the patients were advised isometric quadriceps and ankle pumping exercises on postoperative day 0 (POD0). Patients with less pain did the exercises on POD0 only. They were advocated range of motion exercises and straight leg raising on POD1. Patients with decreased pain and who were comfortable were ambulated with help of a walker on POD2. Range of motion was recorded on day 5, 6 weeks and 12 weeks and 6 months postoperatively. WOMAC scores and KSS scores were noted as shown in outcome evaluation.
Statistical analysis The statistical analysis was carried out using Statistical Package for Social Sciences (SPSS Inc., Chicago, IL, version 15.0 for Windows). All quantitative variables were estimated using measures of central location (mean, median) and measures of dispersion (standard deviation and standard error). Normality of data was checked by measures of skewness and Kolmogorov Smirnov tests of normality. For normally distributed data means were compared using student's t-test for two groups. For more than two groups ANOVA was applied. For Skewed data Mann-Whitney test was applied. Qualitative or categorical variables were described as frequencies and proportions. Proportions were compared using Chi square test. Sensitivity, specificity and diagnostic accuracy of different methods was calculated. All statistical tests were two-sided and were performed at a significance level of α=.05.
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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Chandigarh、インド、160012
- Post Graduate Institute of Medical Education & Research
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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:
- Patient of either sex who underwent primary unilateral or bilateral surgery or the first surgery of a staged bilateral total knee replacement where the second stage was at least 6 weeks later and those who were willing and able to return for follow-up over at least a six month postoperative period.
Exclusion Criteria:
- Patients with preoperative haemoglobin less than 10g/dl and with bleeding disorder were excluded from the study.
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:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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介入なし:コントロールアーム
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実験的:PRP arm
Platelet-rich plasma was applied over the wound including the capsule, medial and lateral recesses.
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PRP ready to be injected was supplied in a syringe in a quantity of 8 ml for each knee.
The entire procedure was done under complete aseptic precautions.
The calcium chloride required for activation was given in a separate syringe in a ratio of 4:1.
About 12-16 ml of platelet rich plasma was obtained by this method and it was used for application.
To confirm sterility, culture and sensitivity of PRP was performed.
Patient's peripheral blood platelet count and the prepared platelet concentrate's platelet count was performed and recorded.
Number of tramadol injections given was also noted
他の名前:
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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 |
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Total amount of Blood loss
時間枠:participants will be followed on day of surgery, post op day 3
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Hemoglobin was measured on the day of surgery and postop day3 by sysmex automated analyser.
Postoperative blood loss was also noted by measuring the weight of soaked dressing and converting it into blood volume.
Number of blood units transfused was also recorded.
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participants will be followed on day of surgery, post op day 3
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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 |
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Pain
時間枠:participants will be followed upto an average of 12 weeks
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Pain was measured daily using VAS scale which consisted of markings from 1 to 10.
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participants will be followed upto an average of 12 weeks
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Wound healing
時間枠:Participants will be followed upto an average of 3 weeks
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Wound was assessed using wound score form.
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Participants will be followed upto an average of 3 weeks
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Range of motion
時間枠:participants will be followed upto an average of 6months.
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Range of motion was recorded on day5, 6weeks and 12weeks and 6months postoperatively.
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participants will be followed upto an average of 6months.
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clinical outcome
時間枠:Participants will be followed upto an average of 6months.
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Functional outcome was measured using both KSS and WOMAC scores.
We assessed the patients at 6weeks, 12weeks and 6months.
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Participants will be followed upto an average of 6months.
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協力者と研究者
捜査官
- 主任研究者:Aditya K Aggarwal, MS DNB D Ort、Post Graduate Institute of Medical Education & Research
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 (見積もり)
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
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痛みの臨床試験
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Dexa Medica Group完了
Platelet rich plasmaの臨床試験
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Womack Army Medical CenterUniformed Services University of the Health Sciences; The Geneva Foundation募集
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Zimmer BiometBiomet Spain Orthopaedics S.L.終了しました
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Belfast Health and Social Care TrustQueen's University, Belfast; NHS Blood and Transplant; Northern Ireland Clinical Trials Unit募集
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Ottawa Hospital Research InstituteCanadian Institutes of Health Research (CIHR); Stem Cell Network積極的、募集していない