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Blood LossPRPTKA2012NCT01563380

Role of Autologous Platelet Rich Plasma in Total Knee Arthroplasty

A study testing Platelet rich plasma in people with Blood Loss and Pain, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Blood Loss, Pain
What is being tested?
Platelet rich plasma
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteIndia
Study dates
Jan 2010to Dec 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Patients with preoperative haemoglobin less than 10g/dl and with bleeding disorder were excluded from the study.

Trial locations and contacts

1 site in 1 country.

India1 site
  • Post graduate institute of Medical Education & Research

    Chandigarh, Chandigarh, 160012

Other trials in India

About this study

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

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.

Read the 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.

Conditions
Blood Loss, Pain
Being tested
Platelet rich plasma
Keywords
total knee arthroplasty, osteoarthritis, autologous Platelet rich plasma, complications, blood loss, Pain, functional outcome
Medical subject headings
Hemorrhage, Pain, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Platelet rich plasmaBiological

    Also called PRP, APG

    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

Study groups in NCT01563380
Study groupRoleWhat they receive
PRP armExperimentalPlatelet-rich plasma was applied over the wound including the capsule, medial and lateral recesses.
Receives: Biological: Platelet rich plasma
Control ArmNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: participants will be followed on day of surgery, post op day 3

Secondary outcomes (4)
  1. Pain

    Pain was measured daily using VAS scale which consisted of markings from 1 to 10.

    Measured: participants will be followed upto an average of 12 weeks

  2. Wound healing

    Wound was assessed using wound score form.

    Measured: Participants will be followed upto an average of 3 weeks

  3. Range of motion

    Range of motion was recorded on day5, 6weeks and 12weeks and 6months postoperatively.

    Measured: participants will be followed upto an average of 6months.

  4. clinical outcome

    Functional outcome was measured using both KSS and WOMAC scores. We assessed the patients at 6weeks, 12weeks and 6months.

    Measured: Participants will be followed upto an average of 6months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2012 (estimated)
  2. Study startJan 2010
  3. Primary completionJun 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01563380
Sponsor's protocol ID
adi_agg_tka_prp-2012
Acronym
PRPTKA2012
Status last verified
Mar 2012
First submitted
15 Mar 2012
Last updated
27 Mar 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Platelet rich plasma in people with Blood Loss and Pain, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total amount of Blood loss (time frame: participants will be followed on day of surgery, post op day 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2012.

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