NCT01563380

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 27, 2012

Completed
Last Updated

March 27, 2012

Status Verified

March 1, 2012

Enrollment Period

1.4 years

First QC Date

March 15, 2012

Last Update Submit

March 26, 2012

Conditions

Blood LossPain

Keywords

total knee arthroplastyosteoarthritisautologous Platelet rich plasmacomplicationsblood lossPainfunctional outcome

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

  • Pain

    participants will be followed upto an average of 12 weeks

  • Wound healing

    Participants will be followed upto an average of 3 weeks

  • Range of motion

    participants will be followed upto an average of 6months.

  • clinical outcome

    Participants will be followed upto an average of 6months.

Study Arms (2)

PRP arm

EXPERIMENTAL

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

Biological: Platelet rich plasma

Control Arm

NO INTERVENTION

Interventions

Platelet rich plasmaBIOLOGICAL

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

Also known as: PRP, APG
PRP arm

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post graduate institute of Medical Education & Research

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

HemorrhagePainOsteoarthritis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Aditya K Aggarwal, MS DNB D Ort

    Post graduate Institute of Medical Education & Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Additional Professor

Study Record Dates

First Submitted

March 15, 2012

First Posted

March 27, 2012

Study Start

January 1, 2010

Primary Completion

June 1, 2011

Study Completion

December 1, 2011

Last Updated

March 27, 2012

Record last verified: 2012-03

Locations

IN(1)