- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01563380
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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Chandigarh, 인도, 160012
- Post Graduate Institute of Medical Education & Research
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 컨트롤 암
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실험적: 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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Total amount of Blood loss
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pain
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Aditya K Aggarwal, MS DNB D Ort, Post Graduate Institute of Medical Education & Research
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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