NCT02713542

Brief Summary

This study is primarily investigating the effectiveness of Autologous Conditioned Plasma (ACP) Intra-articular (IA) in patients with Osteoarthritis (OA) in the knee.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

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

First Submitted

Initial submission to the registry

February 4, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
12 months until next milestone

Results Posted

Study results publicly available

August 13, 2019

Completed
Last Updated

August 13, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

February 4, 2016

Results QC Date

July 19, 2019

Last Update Submit

July 19, 2019

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Pain Scores Measured by Western Ontario and McMaster Universities Index (WOMAC) Survey

    The WOMAC Pain score will be used to measure outcome, the score ranges from 0 to 20. The higher the score indicates greater pain.

    6 month visit

Study Arms (2)

Autologous Conditioned Plasma (ACP)

EXPERIMENTAL

3 Intra-articular (IA) injections at 1 week intervals

Device: ACP

Normal Saline (NS)

PLACEBO COMPARATOR

3 NS Intra-articular (IA) injections at 1 week intervals

Other: Placebo

Interventions

ACPDEVICE

Autologous Conditioned Plasma

Autologous Conditioned Plasma (ACP)
PlaceboOTHER

Three Normal Saline IA injections of 3-8 mL at 1-week intervals.

Also known as: Normal Saline
Normal Saline (NS)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject is 18 to 70 years of age.
  • The subject presents with complaints of continued pain of primary knee for at least 6 weeks.
  • The subject has documented radiographs evidence of Osteoarthritis (OA) in the tibio-femoral or patella-femoral compartment of the target knee (Kellgren-Lawrence Grades II-III), using radiographs performed within 24 weeks of screening.
  • The subject has a WOMAC pain score of at least 8 out of 20 and at least moderate pain (a score of 2) for at least 2 questions on activities

You may not qualify if:

  • Grade I and IV on the knee Kellgren-Lawrence grading scale
  • Subject has clinically 3+ effusion of the target knee (stroke test grading system).
  • Subject has significant (\> 10⁰) valgus or varus deformities as evidenced by standard of care X-ray.
  • Subject has had systemic or IA injection of corticosteroids in any joint within three months prior to screening.
  • Viscosupplementation in any joint in the past six months.
  • Subject has an increased risk for post- procedure bleeding (e.g., bleeding disorder or taking anticoagulants except low-dose aspirin).
  • Subject had prior open surgery on the target knee within 12 months or knee arthroscopy within 6 months
  • Subject has inflammatory disease of either knee other than OA.
  • Subject with underlying medical conditions that could interfere with the evaluation of the outcome.
  • Subject with positive pregnancy test, or breast feeding.
  • Subject with plans to participate in other clinical trial involving medical or surgical intervention in the next 12 months.
  • Subject with any condition (including cognitive impairment) that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
  • Subject has rheumatoid arthritis or gout
  • Subject has a history of or a current infection at the affected joint.
  • Subject with plans to undergo any elective orthopedic surgery in the next 12 months.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MedSport University of Michigan Sports Medicine

Ann Arbor, Michigan, 48106, United States

Location

Columbia Orthopedic Group

Columbia, Missouri, 65201, United States

Location

Hawkins Foundation

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Clinical Affairs Manager
Organization
Arthrex
INC_ClinicalResearch@arthrex.com
2395984302

Study Officials

  • Patrick Smith, MD

    Columbias Orthopedic Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2016

First Posted

March 18, 2016

Study Start

July 1, 2016

Primary Completion

July 2, 2018

Study Completion

August 30, 2018

Last Updated

August 13, 2019

Results First Posted

August 13, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(4)