Osteoarthritis
Conditions
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.
Interventions
DEVICEACP
Autologous Conditioned Plasma
OTHERPlacebo
Three Normal Saline IA injections of 3-8 mL at 1-week intervals.
Sponsors
Arthrex, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores Measured by Western Ontario and McMaster Universities Index (WOMAC) Survey | 6 month visit | The WOMAC Pain score will be used to measure outcome, the score ranges from 0 to 20. The higher the score indicates greater pain. |
Countries
United States
Participant flow
Recruitment details
A total of 126 patients were evaluated and 90 were treated at four sites
Pre-assignment details
A total of 36 patients were excluded before randomization to groups due to not meeting Inclusion/Exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Experimental: Autologous Conditioned Plasma (ACP) Three Intra-articular injections of ACP in knee at 1 week intervals | 60 |
| Control: Normal Saline (NS) Three Intra-articular injections of NS in knee knee at 1 week intervals | 30 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Use of prohibited medication | 14 | 5 |
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | Experimental: Autologous Conditioned Plasma (ACP) | Total | Control: Normal Saline (NS) |
|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 10.3 | 51.3 years STANDARD_DEVIATION 10.6 | 50.6 years STANDARD_DEVIATION 10.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants | 46 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 36 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 8 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 23 Participants | 37 Participants | 14 Participants |
| Race (NIH/OMB) White | 32 Participants | 48 Participants | 16 Participants |
| Region of Enrollment United States | 60 participants | 90 participants | 30 participants |
| Sex: Female, Male Female | 34 Participants | 49 Participants | 15 Participants |
| Sex: Female, Male Male | 26 Participants | 41 Participants | 15 Participants |
| WOMAC pain score of at least 8 | 60 Participants | 90 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 30 |
| other Total, other adverse events | 32 / 60 | 21 / 30 |
| serious Total, serious adverse events | 0 / 60 | 0 / 30 |
Outcome results
Primary
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.
Time frame: 6 month visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Autologous Conditioned Plasma | Pain Scores Measured by Western Ontario and McMaster Universities Index (WOMAC) Survey | 3.98 units on a scale |
| Normal Saline | Pain Scores Measured by Western Ontario and McMaster Universities Index (WOMAC) Survey | 5.54 units on a scale |