Clinical trial NCT02262364: Safety of NStride Autologous Protein Solution in the Treatment of Knee Osteoarthritis (PROGRESS I)
Official title: A Pilot Study of a Single Intra-articular Injection of Autologous Protein Solution in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis, Knee
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: Biomet Biologics, LLC
First posted: 2014-10-13
Enrollment: 11
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the safety of a single injection of APS.

Detailed description: The primary objective of this study is to assess the safety of a single injection of APS in patients with painful unilateral knee osteoarthritis and who have not been able to get satisfactory pain relief with other treatments through one-month post treatment and monitor subjects for adverse events through 12 months.

Eligibility criteria: Inclusion Criteria:

* Male or female ≥40 and ≤75 years old at time of injection..
* A standing radiograph of the knee showing a Kellgren-Lawrence grade of 2 to 4 (within 6 months of screening).
* Body mass index ≤40 kg/m2.
* A Western Ontario and McMaster Universities osteoarthritis index using the Likert scale, Version 3. (WOMAC LK 3.1) pain subscale total score ≥ 10 and ≤ 19.
* Has undergone at least two prior conservative OA therapies without satisfactory pain relief.
* Patient has failed to get satisfactory pain relief from either HA or steroid injections or would be considered an appropriate patient to receive either HA or steroid injections

Exclusion Criteria:

* Presence of active infection or abnormal effusion in the knee immediately preceding treatment injection.
* Presence of symptomatic OA in the non-study knee
* Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, chondromalacia, arthritis secondary to other inflammatory diseases, or of metabolic origin; HIV, viral hepatitis; chondrocalcinosis, Paget's disease, villonodular synovitis, and other non-OA joint disease.
* Disease of spine, hip or other lower extremity joints of sufficient degree to affect assessment of the index knee
* Untreated symptomatic injury of index knee (e.g., acute traumatic injury, anterior cruciate ligament injury, meniscus injury, cartilage lesion).
* Knee radiographs showing bone-on-bone or other gross cartilage deficits.
* Presence of surgical hardware or other foreign body in the index knee.
* Intra-articular steroid injections in the index knee within 3 months of screening.
* Intra-articular HA in the index knee within 6 months of screening.
* Other intra-articular therapy in the index knee within 6 months prior to screening.
* Systemic steroid use within 2 weeks of screening.
* Planned/anticipated surgery of the index knee during the study period.
* A history of local anesthetic allergy
* Use of systemic immunosuppressants within six weeks of treatment.
* Currently on anticoagulant therapy
* Any documented clinically significant condition (e.g., diabetes, malignancy), finding, or psychiatric illness at screening which could compromise patient safety or interfere with the assessment of the safety and treatment effects of the study injection.
* Skin breakdown at the index knee where the injection is planned to take place.
* Pregnant or nursing mothers or women who are planning on getting pregnant during the time they will be participating in the study.
* Known drug or alcohol dependence currently or within the last year.
* Used any investigational drug or device within 30 days prior to screening.
* Used any investigational biologic within 60 days prior to screening

Primary outcomes:
measure: Adverse Events
timeFrame: 1 Year
Secondary outcomes:
measure: Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire
timeFrame: 12 months
measure: Change From Baseline to 12 Months in Pain as Measured by the Numeric Rating Scale (NRS)
timeFrame: 12 months
measure: Change From Baseline to 12 Months in Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 12 months
Other outcomes:
Locations:
city: Elkhart
country: United States
facility: Orthopedic and Sports Medicine Center of Northern Indiana (OSMC)
state: Indiana
Study officials:
affiliation: OSMC
name: Mark Klaassen
role: PRINCIPAL_INVESTIGATOR
References: