Conditions: Post-traumatic Osteoarthritis of the Knee
Keywords: Osteoarthritis Post-traumatic Knee Pain Corticosteroid Intra-articular Injection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 6
Healthy volunteers: no

Brief summary:
This study was a double-blind, randomized, parallel group, proof of concept study comparing FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in patients with post-traumatic osteoarthritis of the knee.

Detailed description:
This study was a double-blind, randomized, parallel group, proof of concept study patients with post-traumatic osteoarthritis (PTOA) of the knee. Approximately 124 eligible patients were intended to be randomized to one of the two treatment groups (1:1) and treated with a single intra-articular (IA) injection of:

* 32 mg of FX006
* 40 mg of Kenalog®-40 (triamcinolone acetonide injectable suspension, USP)

Each prospective patient underwent a screening evaluation to confirm a diagnosis of PTOA of the knee and concurrence with all other eligibility criteria. Patients were be treated on Day 1 (Baseline) and returned to the clinic at Weeks 4, 8 and 12 for evaluation of safety and efficacy.

Arms:
arm 1: Single 5 mL intra-articular (IA) injection Extended-release formulation arm 2: Single 1 mL intra-articular (IA) injection Immediate-release formulation

Interventions: intervention 1: FX006 32 mg intervention 2: TCA IR 40 mg
Intervention descriptions: intervention 1: Experimental intervention 2: Comparator

Protocol document: