Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee

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SCIENCE
Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee
Key Take-Away: 

Hyaluronic acid (HA) injection improves physical knee function and reduces pain and stiffness associated with knee osteoarthritis, while exhibiting an excellent safety profile, especially in comparison with NSAIDs and COX-2 inhibitors.

Osteoarthritis (OA) is a common degenerative disorder of joint characterized by articular pain, cartilage degeneration, and loss of normal joint function. The prevalence of OA increases with age, and more than 60% of individuals over 60 years old.

ABSTRACT: 
Background: 

Osteoarthritis (OA) is a common degenerative disorder of joint characterized by articular pain, cartilage degeneration, and loss of normal joint function. The prevalence of OA increases with age, and more than 60% of individuals over 60 years old. The clinical management of OA is coordinated at diminishing pain, keeping up or enhancing joint mobility, and reduces functional debilitation. Treatment begins with acetaminophen or over the counter NSAID, such as capsaicin cream. NSAID should be used with caution because of gastro intestinal side effects. Recently, American College of Rheumatology (ACR) guidelines have been updated to include recommendations for the use of intra-articular hyaluronan. HA is a carbohydrate polymer that is extensively dispersed in cartilage, synovial fluid, skin, and aqueous humor, it providing support and lubrication, and additionally directing biochemical process thus maintaining normal joint function. Intra-articular HA treatment is intended to restoring normal viscoelastic properties of syn­ovial fluid, thus relieves signs and symptoms of OA.

 

  • Rationale behind research
  1. Numerous clinical trials have documented the efficacy of single courses of HA for pain relief and improvement of joint function. However, injected HA is cleared from the joint in less than one day
  2. Therefore, efficacy, safety, and duration of action of viscosupplementation with Crespine® Gel was evaluated over a 9-month period
  • Objective

To evaluate efficacy, safety, quality of life and duration of action of visco-supplementation with Crespine® Gel. The time-dependent changes in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score taking after the treatment of patients was also evaluated.

Methods: 

 

Study outcomes

  • Primary outcome: WOMAC pain score​
  • Secondary outcomes: WOMAC stiffness, functional, emotional, and social performance scales, and safety​

Time-points

o   Efficacy: Baseline and monthly up to 9 months

Results: 

 

Baseline: All participants were ≥40 years of age (mean age = 55.83 years). Majority were males with 100% being Asian and many had other muscular/skeletal diseases (30.68%) with few having cardiovascular disease

  • The participants who reported improvement in at least one category in WOMAC pain assessment were classified as responders. After treatment the numbers of 20% responders, 50% responders, and 70% responders were reported
  • Sub scores for pain, stiffness and functional performance were 11, 3.8 3.4 at Baseline, 4.8, 1.0 &16.2, at 1 month, 2.60, 0.33, & 9.90 at 5 months, and 3.36, 0.42, & 11.5 at 9 months, respectively
  • The reductions in rates of pain, stiffness, and difficulty performing necessary physical functions (73.8%, 90.2%, and 69% of patients, respectively) were statistically and clinically relevant.
  • Only minor adverse effects reported (transient pain, redness, and swelling at the injection site) and resolved spontaneously or with symptomatic treatment

Figure 1: Reduction in the Mean WOMAC Pain Scores

Figure 2: Reduction in the WOMAC Joint Stiffness

 

Figure 3: Improvement in the Physical Function Score

 

Conclusion: 

Result shows that HA viscosupplementation is a valuable treatment option for OA of the knee, because of safety and efficacy.

Several clinical trials have reported the efficacy of single courses of HA for pain relief and improvement of joint function (Pagnano M et al). Furthermore, studies should be conducted to evaluate their synergistic effects of combining an HA product with current products used for treating patients with OA, as well as to determine the effect of intra-articular Crespine®Gel injection on patients with different grades of knee OA.

Drug Design, Development and Therapy 2015; 9:2063–2072
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