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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aditya K Aggarwal, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01563380
First received: March 15, 2012
Last updated: March 26, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Blood Loss
Pain
Biological: Platelet rich plasma

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Total amount of Blood loss [ Time Frame: participants will be followed on day of surgery, post op day 3 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: participants will be followed upto an average of 12 weeks ] [ Designated as safety issue: Yes ]
    Pain was measured daily using VAS scale which consisted of markings from 1 to 10.

  • Wound healing [ Time Frame: Participants will be followed upto an average of 3 weeks ] [ Designated as safety issue: Yes ]
    Wound was assessed using wound score form.

  • Range of motion [ Time Frame: participants will be followed upto an average of 6months. ] [ Designated as safety issue: Yes ]
    Range of motion was recorded on day5, 6weeks and 12weeks and 6months postoperatively.

  • clinical outcome [ Time Frame: Participants will be followed upto an average of 6months. ] [ Designated as safety issue: Yes ]
    Functional outcome was measured using both KSS and WOMAC scores. We assessed the patients at 6weeks, 12weeks and 6months.


Enrollment: 40
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRP arm
Platelet-rich plasma was applied over the wound including the capsule, medial and lateral recesses.
Biological: Platelet rich plasma
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
Other Names:
  • PRP
  • APG
No Intervention: Control Arm

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563380

Locations
India
Post graduate institute of Medical Education & Research
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Aditya K Aggarwal, MS DNB D Ort Post graduate Institute of Medical Education & Research
  More Information

No publications provided

Responsible Party: Aditya K Aggarwal, Additional Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01563380     History of Changes
Other Study ID Numbers: adi_agg_tka_prp-2012
Study First Received: March 15, 2012
Last Updated: March 26, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Postgraduate Institute of Medical Education and Research:
total knee arthroplasty
osteoarthritis
autologous Platelet rich plasma
complications
blood loss
Pain
functional outcome

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014