Intended use:

To improve mobility of the hip joint, help muscle stretching on the lumbo-sacral area, help to support peri-articular muscle tissue, soothe local pain and pain due to joint movement or bad posture.

Composition: Collagen
Excipients: Calcium phosphate, NaCl, Water for .

MD-HIP is a medical device finalized to help movement by limiting a physiological degeneration of joints and tissues as well as by counterbalancing any damage caused by:

• aging
• bad posture
• concomitant chronic diseases
• blows and injuries

 

MD-HIP is a medical device that helps hip movement. Its main therapeutic functions include:

1. a barrier effect
2. a lubricating activity
3. a mechanical support while administering other pharmacological treatments

 

MD-HIP is a medical device intended to be used by a qualified staff in private or public health facilities.

 

Directions for use

Treatment protocol:

1 treatment a week for 10 weeks.

Periarticular technique: (the site of application must be sterile; insert the needle at 6-8 mm depth).

For this purpose the use of the following materials and accessories is recommended:

• Materials for aseptic skin preparation: sterile gloves, Iodine solution, Alcohol solution, sterile gauze pads, Ethyl chloride spray for the skin.
• Needles: Sterile 27 G.
• Syringes: 5 or 10 cc size, according to the volume of the solution to inject.

 

Intraarticular technique:

For this purpose the use of the following materials and accessories is recommended:

• Materials for aseptic skin preparation: sterile gloves, Iodine solution, Alcohol solution, sterile gauze pads, Ethyl chloride spray for skin.
• The application of a topical anaesthetic on the skin area to be treated is recommended.
• Needles: Sterile 27 G.
• Syringes: 2 cc size, according to the volume of the solution to inject.

 

The trochanteric bursa is located over the lateral prominence of the greater trochanter of the femur. There can be an anterior or a lateral approach to the hip. The patient is lying supine. The anatomic landmark is located 2 cm below the superior border of the greater trochanter in between its anterior and posterior borders. The skin overlying this location is marked and prepared in a sterile way. A 22 gauge needle is injected parallel to the floor and perpendicular to the femoral shaft.

 

Contraindications / Side effects

Patients treated with anticoagulants or with recognized vessel fragility should be carefully monitored during the therapy.

There is no history of hypersensitivity to MD-HIP. However, patients with a recognized hypersensitivity to any ingredient or excipient should be tested before use, making a spot into one arm and be monitored for 1 hour.

 

Performance

MD-HIP may be used as a single treatment or mixed with other medical devices of the same range, in order to make a customized treatment according to clinical evolution.

When a supportive treatment is needed for acute pain, MD-HIP can be associated with MD-NEURAL, MD-POLY and MD-MUSCLE (together with one or more than one of these).

Moreover, when a supportive treatment is needed for the connective tissue matrix or when the physiological aging process is needed to be slowed down, MD-HIP can be associated with MD-MATRIX and MD-TISSUE.

It may also be used as a mechanical support while treating the following diseases:

• Hip joint osteoarthritis
• Hip joint capsule inflammation
• Hip joint osteoarthritis with rheumatoid arthritis

(in association with MD-POLY)

• Hip joint pain of muscle origin

(in association with MD-MUSCLE)

• Hip joint pain of nerve origin

(burning hip, in association with MD-NEURAL)

• Hip joint pain due to prolonged bed rest.

 

Administration may vary according to individual needs.

 

Instructions in case of damage to the sterile vials / ampoules

Do not use if the seal is open or if the vial/ampoule is not perfectly sealed.

Once open, the vial/ampoule must be immediately injected. Do not use if the package is damaged.

 

Warnings and precautions

Hip pain requires differential diagnosis for primary or metastatic cancer pain, referred nerve pain from lumbar origin, inguinal hernia.

A slight reddening at the site may be due to a mechanical effect of the needle or to a skin superficial reaction.

Skin cleansing/disinfection is required before and after application. Saprophytic bacteria may produce site abscesses. KEEP AWAY FROM THE REACH AND THE SIGHT OF CHILDREN.

Do not use after the expiration date. The expiration date refers to the product properly stored in an unopened package. Use the product immediately after opening the package.