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Role of Autologous Platelet Rich Plasma in Total Knee Arthroplasty (PRPTKA2012)

Primary Purpose

Blood Loss, Pain

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Platelet rich plasma
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Loss focused on measuring total knee arthroplasty, osteoarthritis, autologous Platelet rich plasma, complications, blood loss, Pain, functional outcome

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Post graduate institute of Medical Education & Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PRP arm

Control Arm

Arm Description

Platelet-rich plasma was applied over the wound including the capsule, medial and lateral recesses.

Outcomes

Primary Outcome Measures

Total amount of Blood loss
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.

Secondary Outcome Measures

Pain
Pain was measured daily using VAS scale which consisted of markings from 1 to 10.
Wound healing
Wound was assessed using wound score form.
Range of motion
Range of motion was recorded on day5, 6weeks and 12weeks and 6months postoperatively.
clinical outcome
Functional outcome was measured using both KSS and WOMAC scores. We assessed the patients at 6weeks, 12weeks and 6months.

Full Information

First Posted
March 15, 2012
Last Updated
March 26, 2012
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT01563380
Brief Title
Role of Autologous Platelet Rich Plasma in Total Knee Arthroplasty
Acronym
PRPTKA2012
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study was designed to evaluate the efficacy of leucocyte free autologous platelet rich plasma on blood loss, pain, wound healing and functional outcome after total knee arthroplasty. The investigators hypothesized that application of platelet rich plasma would help in reducing blood loss, postoperative pain and expedite wound healing and better short-term functional outcome following total knee arthroplasty.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Pain
Keywords
total knee arthroplasty, osteoarthritis, autologous Platelet rich plasma, complications, blood loss, Pain, functional outcome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRP arm
Arm Type
Experimental
Arm Description
Platelet-rich plasma was applied over the wound including the capsule, medial and lateral recesses.
Arm Title
Control Arm
Arm Type
No Intervention
Intervention Type
Biological
Intervention Name(s)
Platelet rich plasma
Other Intervention Name(s)
PRP, APG
Intervention Description
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
Primary Outcome Measure Information:
Title
Total amount of Blood loss
Description
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.
Time Frame
participants will be followed on day of surgery, post op day 3
Secondary Outcome Measure Information:
Title
Pain
Description
Pain was measured daily using VAS scale which consisted of markings from 1 to 10.
Time Frame
participants will be followed upto an average of 12 weeks
Title
Wound healing
Description
Wound was assessed using wound score form.
Time Frame
Participants will be followed upto an average of 3 weeks
Title
Range of motion
Description
Range of motion was recorded on day5, 6weeks and 12weeks and 6months postoperatively.
Time Frame
participants will be followed upto an average of 6months.
Title
clinical outcome
Description
Functional outcome was measured using both KSS and WOMAC scores. We assessed the patients at 6weeks, 12weeks and 6months.
Time Frame
Participants will be followed upto an average of 6months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aditya K Aggarwal, MS DNB D Ort
Organizational Affiliation
Post graduate Institute of Medical Education & Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Post graduate institute of Medical Education & Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

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