Crespine Gel

Indication

Crespine Gel is indicated for pain and functional impairment of joints caused by degenerative changes — osteoarthritis of the knee (gonarthrosis) and of the hip. It is intended for joints with a degenerated cartilage surface and pathologically altered synovial fluid.

Mode of action

Crespine Gel is injected into the joint space to supplement the altered synovial fluid. The viscoelastic gel is intended to improve lubrication and cushioning of the joint; the published cohort data describe reduced pain and improved joint function after a single injection. Thanks to CRM® cross-linking, the implant is resorbed slowly, so one injection covers a full treatment cycle.

Composition per 1 ml

Pack and handling

• One sterile 2 ml prefilled syringe with integrated Luer-Lock connection, sealed in a blister. Needles are not included.
• The pack contains the instructions for use and batch labels for the patient record.
• Store at 2–25 °C, do not freeze. Shelf life: three years from the date of manufacture.
• Single use. The injection is placed intra-articularly under aseptic conditions; the injection technique is decisive for the result.

Clinical evidence

In a prospective, open-label phase IV study in Jordan, 84 patients with knee osteoarthritis (Kellgren–Lawrence grades I–IV) were followed for nine months after a single 2 ml injection of Crespine Gel. WOMAC pain decreased from 10.99 to 3.36 (scale 0–20), stiffness from 3.77 to 0.42 (0–8) and function from 34.35 to 11.49 (0–68) at month 9, all p < 0.0001. 82 % of patients reached a 50 % pain response. The study had no control group.

Bashaireh K et al. Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee: a post-marketing Phase IV study. Drug Des Devel Ther. 2015;9:2063–2072. Source

All study details

Safety information

Transient reactions at the injection site — pain, swelling, redness, warmth — can occur in the first days after injection and usually subside within a few days. In the 2015 study, 39 % of patients reported increased knee pain within 72 hours, resolving after two to three days; no serious adverse events were observed. Hypersensitivity to hyaluronic acid is rare and may appear with a delay.

Contraindications (selection)

• known hypersensitivity to hyaluronic acid
• active inflammation or infection in or near the joint, or skin disease at the injection site
• autoimmune diseases
• intolerance to proteins of gram-positive bacteria
• treatment with anticoagulants

Precautions

Not for intravascular injection. No data are available for pregnancy, breastfeeding or patients under 18 years. Several joints should not be treated at the same time. Aspirate before injecting.

This summary does not replace the instructions for use (IFU) supplied with the product. Contraindications, warnings and precautions are listed in full in the IFU.

For patients

Crespine Gel is a gel made of hyaluronic acid, a substance that occurs naturally in the joint. Your doctor injects it into the affected joint to supplement the joint fluid. Whether the treatment is suitable for you, what you can expect and which alternatives exist is something only your doctor can assess. Please discuss it with an orthopaedic specialist.

Availability

Crespine Gel and Crespine Gel+ are supplied through our distribution partners. Healthcare professionals can contact us for the partner responsible for their country; companies interested in distribution can find the details on the partner page.