NCT03158623

Brief Summary

3 cohorts of total joint patient of 30 members each were randomized to receive PRP or Activated Collegen or no additive were studied for status of the wound at 6 weeks and recorded all complications, infections and reoperations. The three groups were than compared for statistical analysis

Trial Health

100
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_3

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2016

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
Last Updated

May 18, 2017

Status Verified

May 1, 2017

Enrollment Period

8 months

First QC Date

May 15, 2017

Last Update Submit

May 17, 2017

Conditions

Arthroplasty, Replacement

Keywords

total joint arthroplastyplatelet-rich plasmaactivated collagen

Outcome Measures

Primary Outcomes (1)

  • Wound Status

    wound hematoma, dehiscence, superficial infection

    6 weeks post operative

Study Arms (2)

Platelet Rich Plasma

EXPERIMENTAL

30cc of PRP was administered at closure of wound

Biological: Platelet Rich Plasma

Cellerate (Activated Collegen)

EXPERIMENTAL

1gm of Cellerate was administered at closure of wound

Biological: Cellerate

Interventions

Platelet Rich PlasmaBIOLOGICAL
Also known as: PRP
Platelet Rich Plasma
CellerateBIOLOGICAL
Also known as: Activated college
Cellerate (Activated Collegen)

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Osteoathritis of knee and hip

You may not qualify if:

  • Inflammatory arthritis and hypercoagulable state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
computer generated randomization
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 3 groups with identical surgical closures randomized into 2 groups with wound additives and the third group without wound additives.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 18, 2017

Study Start

April 1, 2016

Primary Completion

December 6, 2016

Study Completion

December 20, 2016

Last Updated

May 18, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

no plan on sharing data