A Pilot Study of a Single Intra-articular Injection of Autologous Protein Solution (APS) in Patients with Osteoarthritis (OA) of the Knee.

Completed

• Conditions: bad knee; Osteoarthritis (OA) of the Knee; 10023213

• Registration Number: NL-OMON38437
• Lead Sponsor: BioMet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Male or female >=40 years.
2. Body mass index (BMI) <=40 kg/m2.
3. A standing radiograph of the knee showing a Kellgren grade of 2 or 3 (within 6 months prior to screening or at screening).
4. Frequency of knee pain on most days (>15 days) over the last month.
5. Diagnosis of unilateral knee OA according to the American College of Rheumatology (ACR) criteria (clinical and radiological categories) based on an x ray performed within 6 months prior to screening.
7. On the WOMAC LK 3.1 questionnaire, the mean total score of the 5 pain subscale items together must be >=2.0 at screening and at baseline (Day 1 pre-injection).
8. Failed at least 1 conservative OA therapy (physiotherapy and/or simple analgesics)

Exclusion Criteria

1. On Day 1 (pre-injection), presence of active infection or abnormal effusion in the knee as noted by a physical examination (e.g., erythema, redness, heat, swelling).
2. Diagnosed with rheumatoid arthritis (RA), Reiter*s syndrome, psoriatic arthritis, ankylosing spondylitis, chondromalacia, arthritis secondary to other inflammatory diseases (e.g., inflammatory bowel disease [IBD], sarcoidosis, or amyloidosis).
3. Arthritis of metabolic origin.
4. Ipsilateral hip OA.
5. Untreated traumatic injury of knee.
6. Limited daily activity for reasons other than OA.
7. Presence of surgical hardware or other foreign body in the knee.;Prior or concomitant OA treatment-related criteria:
8. Arthroscopy or open surgery in knee within12 months prior to screening.
9. Intra-articular steroid injections in any joint within 3 months prior to screening.
10. Intra-articular hyaluronic acid (HA) in any joint within 6 months prior to screening.
11. Other intra-articular therapy in any joint within 3 months prior to screening.
12. Taking systemic steroids within 2 weeks prior to screening.
13. Planned/anticipated surgery of the knee during the study period.;Patient-related criteria:
14. Any clinically significant results at screening (values or findings outside of normal ranges that are deemed clinically significant by the investigator).
15. Active or history of malignancy other than non-melanoma skin cancer.
16. Any serious, non-malignant, significant, acute, or chronic medical condition (e.g., diabetes, cardiopathy) or active psychiatric illness that, in the investigator*s opinion, could compromise patient safety, limit the patient*s ability to complete the study, and/or compromise the objectives of the study.
17. Skin breakdown at the knee where the injection is planned to take place.
18. Pregnant or nursing mothers, or women likely to conceive a child and unwilling to use a reliable form of birth control for the duration of the study.
19. History of drug or alcohol dependence and/or positive screening results from urine drug and alcohol tests.
20. Used any investigational drug or device within 30 days prior to screening, or 5 half-lives, whichever is longer.
21. Used any investigational biologic within 60 days prior to screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter will be safety and tolerability data which will<br /><br>include the number, timing, severity, duration, and resolution of device- and<br /><br>non-device-related AEs and injection-site reactions; physical examination<br /><br>results; knee examination findings; vital signs; ECGs; and clinical laboratory<br /><br>evaluations</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameter will be pain and function of the knee joint.<br /><br>Results of the WOMAC LK 3.1 questionnaire (overall score and pain, stiffness,<br /><br>and functionality subscores) and changes from baseline to post-injection time<br /><br>points will be summarized overall and by time point. In addition, results of<br /><br>the global assessments (CGI S, CGI C, Efficacy Index, PGI S, and PGI C) will be<br /><br>summarized overall and by time point. The incidence of patients using rescue<br /><br>medication for OA pain and the average amount of rescue medication used for OA<br /><br>pain per week will be summarized descriptively</p><br>