Intended use

MD-HIP is a medical device designed 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
• pollutants.

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

A barrier effect.

A lubricating action.

Mechanical support while administering other pharmacological treatments.
MD-HIP is intended to be used by a qualified staff in private or public health Facilities to:
➩ Improve the movement of the hip joint.
➩ Help muscle stretching of the umbosacral area.
➩ Support the periarticular muscle tissue.
➩ Soothe local pain, pain caused by joint
movement or bad posture.

Directions for use
Therapeutic protocol:
1 treatment weekly for 10 consecutive weeks.
Periarticular injection technique (the site of
application must be aseptic; 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: single-use 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 injection technique
For this purpose the use of the following materials and accessories is recommended:
• Materials for aseptic skin preparation: single-use gloves, iodine solution, alcohol solution, sterile gauze pads, ethyl chloride spray for the skin.

The application of a topical anaesthetic on the skin area to be treated is recommended.
• Needles: sterile 22 G.
• Syringes: 2 cc size, according to the volume of the solution to inject.

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. It contains animal-derived collagen from porcine source. Patients with known hypersensitivity to any ingredient or excipient should be tested before use, making a spot injection into one arm and be monitored for 1 hour.

Warnings and precautions
Hip pain requires differential diagnosis for primary or metastatic cancer pain, referred nerve pain of lumbar origin, inguinal hernia.
A slight reddening at the injection site may be due to a mechanical effect of the needle or to a skin reaction. The application might cause symptoms of burning/pain at the injection site, that usually solve spontaneously within 5-10 minutes after the treatment.
Skin cleansing/disinfection is required before and after application. Pyogenic bacteria may produce injection site abscesses.


Do not use after the expiration date. The expiration date refers to a product properly stored in its original and undamaged package. Use the product immediately after opening. Instructions on use MD-HIP may be used as a single treatment or mixed with other medical devices of the same
range in order to make a customised 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 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

Do not use if the seal is broken or if the vial is not perfectly sealed. Once open, the content of the vial must be immediately injected. Do not use if the package is damaged.

Hip – Intraarticular injection

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.

Subcutaneous (s.c.) and intradermal injections: use a 12-16mm, 25-28G needle.
Intramuscular (i.m.) injections: use a 40mm, 21G needle
Intra-articular injections: use a dedicated needle.
• When making subcutaneous injections, insert the needle at approximately a 45 degree angle
• When making intramuscular injections, insert the needle at approximately a 90 degree angle



Authors: Migliore A., Massafra U., Bizzi E., Vacca F., Tormenta S.
– Clinical trial presented at the International Symposium Intra Articular Treatment; Rome (October 2011).

Experimental sites: UOS (Simple Operating Unit) of Rheumatology – San Pietro Fatebenefratelli Hospital, Rome.

Pathologies considered: osteoarthritis X-Ray I-III stage according to Kellgren-Lawrence affecting the hip joint unresponsive to viscosupplementation with hyaluronic acid (6 patients) or hylan (1 patient) (2 ultrasound guided injections at least).

1)assessment of efficacy using VAS scale and Lequesne algofunctional Index;
2)NSAIDs consumption before treatment and during follow-up. 3)safety profile of MD-Hip.

Patients enrolled: 7

Treatment: MD-Hip (2 ampoules = 4 ml), 1 ultrasound guided intra-articular injection.

1) VAS of osteoarthritis pain = from 6.15 (before treatment) to 4.23 (after 3 months), to 4.23 (after 6 months).
2) Lequesne Index = from 1.94 (before treatment) to 5.9 (after 3 months), to 5.83 (after 6 months).
3) NSAIDs consumption = from 7.57 (before treatment) to 4.25 (after 3 months), to 5.78 (after 6 months).

– Author’s conclusions:
1) MD-Hip showed to be effective (all the average values of the results at 3 and at 6 months after the last treatment have been statistically significant) and safe in patients affected by hip osteoarthritis unresponsive to viscosupplementation.
2) The data suggest that the results can be evident from the very first injection and are stable for 6 months.
3) The preliminary data offer new research opportunities in the field of intra-articular therapy.