Clinical trial NCT02713542: Autologous Conditioned Plasma (ACP) Intra-articular (IA) Injections for Knee Osteoarthritis (OA)
Official title: Autologous Conditioned Plasma (ACP) Intra-articular (IA) Injections for Knee Osteoarthritis (OA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Arthrex, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study is a prospective, multi center randomized double blind, two arm study.

90 subjects will be randomized to receive injections of either Autologous Conditioned Plasma Intra-articular or the control.

Eligibility criteria: Inclusion Criteria:

1. The subject is 18 to 70 years of age.
2. The subject presents with complaints of continued pain of primary knee for at least 6 weeks.
3. 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.
4. 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

Exclusion Criteria:

1. Grade I and IV on the knee Kellgren-Lawrence grading scale
2. Subject has clinically 3+ effusion of the target knee (stroke test grading system).
3. Subject has significant (\> 10⁰) valgus or varus deformities as evidenced by standard of care X-ray.
4. Subject has had systemic or IA injection of corticosteroids in any joint within three months prior to screening.
5. Viscosupplementation in any joint in the past six months.
6. Subject has an increased risk for post- procedure bleeding (e.g., bleeding disorder or taking anticoagulants except low-dose aspirin).
7. Subject had prior open surgery on the target knee within 12 months or knee arthroscopy within 6 months
8. Subject has inflammatory disease of either knee other than OA.
9. Subject with underlying medical conditions that could interfere with the evaluation of the outcome.
10. Subject with positive pregnancy test, or breast feeding.
11. Subject with plans to participate in other clinical trial involving medical or surgical intervention in the next 12 months.
12. Subject with any condition (including cognitive impairment) that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
13. Subject has rheumatoid arthritis or gout
14. Subject has a history of or a current infection at the affected joint.
15. Subject with plans to undergo any elective orthopedic surgery in the next 12 months.
16. Subject requires pain management therapy (with the exception of acetaminophen) not related to the target knee.

Primary outcomes:
measure: Pain Scores Measured by Western Ontario and McMaster Universities Index (WOMAC) Survey
timeFrame: 6 month visit
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Ann Arbor
country: United States
facility: MedSport University of Michigan Sports Medicine
state: Michigan
city: Columbia
country: United States
facility: Columbia Orthopedic Group
state: Missouri
city: Greenville
country: United States
facility: Hawkins Foundation
state: South Carolina
Study officials:
affiliation: Columbias Orthopedic Group
name: Patrick Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: