THE COLLAGEN MEDICAL DEVICES IN THE LOCAL TREATMENT OF THE ALGIC ARTHRO-RHEUMOPATHIES

THE COLLAGEN MEDICAL DEVICES IN THE LOCAL TREATMENT OF THE ALGIC ARTHRO-RHEUMOPATHIES

REVIEW OF THE CLINICAL STUDIES AND CLINICAL ASSESSMENTS 2010-2012

INTRODUCTION

Reliable epidemiologic data recorded in Italy (Mannaioni et Al., 2003) and in Europe [Jordan et Al., 2003-European League Against Rheumatism (EULAR)] show that 15-20% of the general population suffers from pathologies involving the osteo-arthro-myo-fascial Apparatus (better defined as arthro-rheumopathies), representing 70% of the patients with chronic pain.


– In the near future, these data will probably undergo an increase, especially due to increased life expectancy, overall average increase in body weight, greater propensity to inactivity amid people above 50, higher incidence of amateur sports activity and consequent traumas (mostly among people aged between 20 and 45), overuse of NSAIDs and unhealthy diet, basically high in proteins. The arthro-rheumopathies (connective tissue inflammatory and/or degenerative diseases) are all characterized by collagen disorders.

Collagen’s physiological tissue organization and quantitative and qualitative composition – which dramatically decrease from = 60 years of age (Heine, 2009) – determines the organoleptic characteristics of connective tissues. – Collagens are merged into a vast family of structural proteins of the extra-cellular matrix having unique and peculiar characteristics, also from the phylogenetic point of view (in Milani, 2010).

Up to the present more than 30 genetically
distinct varieties (Types) of collagen have been identified.Genetic alterations of some Types of
collagen determine complex and paradigmatic phenotypes (alterations in the collagen Type I: e.g. osteogenesis imperfecta; Type I, III, V: e.g. Ehlers-
Danlos syndrome; Type IV: e.g. Alport syndrome; Type II, XI: e.g. cartilage genetic diseases). The fibrillar collagen Type I (COL1A1 and COL1A2 coding genes) is the most abundant ubiquitous protein in adult humans, accounting for 90%of the total collagen: it is involved in the

A

A – Continuity of collagen fibers in the ligament of adult rats.
Electron Microscope images from Provenzano P.P. and Vanderby R. Jr. – Collagen fibril morphology
and organization: Implication for force transmission in ligament and tendon. Matrix
Biology 25(2006) 71-84.

composition of the main connective tissues and represents the bulk of certain structures such as skin, dentine, cornea, joint capsules, ligaments, tendons, aponeurotic layers and fibrous membranes. – In the tendons, for example, collagen Type I = 97%; elastin = 2%; proteoglycans = 1-5%; inorganic components (Cu, Mn, Ca) = 0.2% (Jozsa and Kannaus, 1997; Lin et Al., 2004); in ligaments, collagen Type I = 85% (Frank, 2004; Vereeke et Al., 2005). The in vivo fibrillogenesis is a multi-step process involving both the intracellular compartment and the extracellular one, defined by tenocyte (a very specialized fibrocyte) (FIG. 1). – The tenocyte, in addition to collagen Type I, also synthesizes the matrix proteoglycans (PGs) and the metalloproteinase (MMP) 1-interstitial which is involved, together with the MMP8-neutrophil, in the degradation of the fibrils, either because old or damaged by the inflammatory/traumatic process (Birk et Al., 1995; Canty, 2004). The MMP1 is primarily involved in the processes of fibrillo- (collagen)-lysis: the study of Maeda et Al. (1995) highlights a very high concentration of MMP1 in the synovial fluid of patients with rheumatoid arthritis, which is related to the degree of inflammation (reliable marker of the disease status). Provenzano andVanderby Jr. (2006) ), using the electron microscope, exhibit a wide range of very impressive photographs proving that healthy adults collagen fibrils (FIG. 2A) are very precise, parallel to each other, continuous and laid longitudinally along the main axes of the anatomical structures to which they belong and which characterize, transmitting the force directly and not through the PGs bridges.

– The collagen turnover is very slow. The mechanical failure and the presence of free radicals can increase the degenerative process, causing a spontaneous, slow and imperfect neofibrillogenesis: the process of spontaneous repair leads to the neoformation of disordered, twisted, juxtaposed, discontinuous fibers, (FIG. 2B), morphologically much more similar to the fetal ones rather than the adult ones (Provenzano et Al., 2001). It also leads to increased vascularization and increased deposits and clusters of inflammatory cells. These phenomena all contribute to the further weakening of collagen Type I (Shrive et Al., 1995; Frank et Al., 1999) and to the increased synthesis of collagen Type III (Liu et Al., 1995; Hsu et Al., 2010), which is functionally much less suitable.
B

B – Post-traumatic repair of the collagen texture.
Electron Microscope images from Provenzano P.P., Hurschler C., Vanderby R. Jr. – Connect.
Tiss. Res. 42:123-133, 2001.

During the fibrillogenesis process, the PGs play a crucial role in guiding and stabilizing neofibrils, assisted by the SLPR (Small Leucine Rich Proteoglycans) (Jepsen et Al., 2002), represented above all by decorin, lumican, and fibromodulin. The rare overt genetic alterations of these 3 small PGs affect distinct phenotypes, clinically severe. – Minor alterations with variable penetrance and expressivity are probably not diagnosed and are the primary cause of highly pathologically susceptible conditions: collagen fibrils altered in shape and diameter which affect the joints and posture long before the physiological decay. – I conclude these brief topics on collagen, which supplement and detail what presented in a previous publication (Milani, 2010) to which I refer, indicating that collagen is also a template for bone mineralization, which promises new and revolutionary solutions in Orthopedics and Traumatology.

The anatomical structures composing the extra-articular environment of the joints – with containing and stabilizing functions – are represented by:

  1. joint capsule, ligaments and fibrous membranes (“direct hold”);
  2. tendons and muscles (“indirect hold”).

These elements – which unite and wrap the distal end of a bone and the proximal end of the adjacent bone (superoinferior) (bone segments in connection) – are the actors of the containment-stabilization and of the joint mobility.
– Although anatomically distinct and functionally different, these structures are in close continuity (contiguous or overlapping anatomical planes; some collagen fibers of each structure merge with the neighboring ones) to form an elastic-stretch sleeve performing primarily two functions:

  1. Articular establishment in static / dynamic physiological position;
  2. Articular mobility with maximum range.

FIGURE 3 shows as exemplification the fibrous structures of the extra-articular environment of the elbow.
– In addition to the extra-articular structures, few joints also have intra-articular intrinsic ligaments that connect two skeletal segments inside the joint capsule (e.g. cruciate ligaments of the knee joint, coxofemoral round ligament).
– The extra-articular structures (primarily: joint capsule, ligaments and tendons) are constituted by collagen Type I: the quality and the quantity of this protein ensure a physiological joint movement, repeated over time and optimal movement.

Progressive depletion and / or damage to organoleptically suitable collagen Type I is produced by aging (discrepancy between neofibrillogenesis and fibrillo-lysis), misuse or disuse of the joints, traumas aggravated by the coexistence of internal diseases and – in some age groups – even by vitamin deficiencies (vitamin C, but also vitamin A and E), copper
deficiency, noble proteins deficiency, and the use / abuse of drugs (particularly corticosteroids).
– In particular, Elder et Al. (2001), Warden (2005), and Warden et Al. (2006) show that NSAIDs COX-2 inhibitors inhibit the healing of injured ligaments, leading to the lack of mechanical strength (imbalance between joint stability and mobility) and causing extra- and intra-articular damages. The trial of these drugs demonstrates unequivocally that the anti-inflammatory benefit in the short term is converted into serious harm in the medium and long term.
– Fournier et Al. (2008), and Ziltener et Al. (2010) maintain that the use of NSAIDs in the treatment of periarticular soft tissues (ligaments, capsule) should be very limited in time, or absent.

A – Left elbow joint, front.
B – Right elbow joint, front.
The containing and stabilizing
structures of the elbow joint are
represented by extra-articular
connective-collagen Type 1 structures.
They are represented by:
– ulnar collateral ligament (A, B);
– radial collateral ligament (A, B);
– anular radial ligament (A, B);
– sacciform recess (A);
– joint capsule (lifted in A; B);
– brachial biceps tendon (B).
All these structures allow the
large variations in flexion, extension
and torsion of the forearm on
the arm.
– Images translated and elaborated by the
author from W. Spalteholz – R. Spanner,
Atlante di Anatomia Umana. Società
Editrice Libraria (Vallardi) – Milano, 5th Italian
edition (1962) in the 16th German edition
(1959-61); 1st Vol.; pp. 232-3.

Barton and Bird (1996) indicate the laxity or hyperlaxity of anatomical structures as the most important cause of pain of one or more joints. The quoted authors’ studies follow those by:

  • Rotes-Querol (1957), which identified joint laxity as the main factor of altered posture;
  • Teneff (1960), indicating the clinical significance of congenital
    joint laxity;
  • Donayre and Huanaco (1966), which show that the orthopedic
    joint laxity is the cause of many diseases (defined
    by the authors as “arthrocalasis”).
    Recently:
  • Philippon and Schenker (2005) show high incidence of
    coxofemoral traumas in athletes with femoral laxity;
  • Paschkewitz et Al. (2006) describe the generalized ligament
    laxity associated with proximal dislocation of the tibio-
    peroneal joint;
  • Hauser and Dolan (2011), indicate in joint instability and
    unhealed ligament injuries the primary cause of osteoarthritis.

These are just some historical data and the most recent ones among those that can be extrapolated from the available literature on the topic which indicate that the joint hypermobility due to deficiency of joint containment (ultimately: deficiency of collagen Type I in the extra-articular environment) is the primary cause of the arthropatic etiology.
It is necessary to distinguish between joint hypermobility due to impaired containment from the one due to paraphysiological laxity, such as:

  • in childhood (Cheng et Al., 1993; Bird, 2005; Simpson, 2006);
  • in females, especially during the menstrual cycle (Schultz, 2005);
  • In individuals belonging to African (Beighton et Al., 1973) and eastern (Walker, 1975) anthropological varieties,

and the one due to joint instability of various pathological degree, which starts when the contiguous bone segments forming a joint do not respect the optimal axes and – consequently the angles among them. Paradigmatic examples – not the only ones, though – of such situations are:

  • valgus/varus tibio-femoral joint (FIG. 4) and valgus/varus coxofemoral joint,
  • the extra/internal rotation of the head of the femur in the acetabulum,
  • the lordosis/kyphosis of the rachis segments,
  • cavus/flat foot.

Situations that can worsen joint hypermobility are paraphysiological variations and real alterations of the diaphyseal shape, the alteration of the muscle tone and abnormal proprioception.

All the above conditions necessarily lead to pathological osteo-cartilaginous hyperload which cause the overuse processes. The bone reacts with the production of marginal osteophytes, subchondral bone cysts, subcortical hardenings or deformities and/or epiphyseal osteopenia.

These extra-physiological forces cause, especially in the load joints, slippage of the adjacent bone heads, which are anteroposterior, medium-lateral and rotational of greater or lesser severity.

– In such situations the loose structures of the extra-articular environment are exposed to mechanical stress: the pain due to extra-articular cause is added to the one due to intra-articular cause (which is frequently inflammatory), thus aggravating the status and prognosis of the disease.

The organism performs mechanisms of local and remote compensation by establishing the activation (hyperactivation) of ascendants and descendants muscle-proprioceptive chains which only rarely get the desirable effect: the control of the vascular tone is unintentional and self-organizing, at central and peripheral level.

– Currently, the treatment of arthro-reumopaties offers different options; it includes different, unique treatments or – more frequently – a combination of:

  • non-pharmacological treatments (e.g. ultrasound therapy, magnetic therapy, laser therapy, TENS, acupuncture, moxibustion, etc.);
  • conventional pharmacological treatments [e.g. COXIB, NSAIDs, paracetamol, corticocosteroids (the latter also intra- articularly injected)];
  • unconventional pharmacological treatments [e.g. specific medicines formulated by Homeopathy, Homotoxicology (the latter also via intra-articular injection, periarticular injection, mesotherapy, homosiniatry treatment), Physiological Regulating Medicine, Herbal Medicine];
  • physical-rehabilitation treatments (see review by Di Domenica et Al., 2004);
  • surgical treatment: mobile (prosthesis, especially hip, knee, shoulder) or fixed (arthrodesis).

Symptomatic slow-acting treatments include viscosupplementation with hyaluronic acid (see review by Bellamy et Al., 2008) or with hylan G-F 20 (derived from the hyaluronic acid) (see review by Conrozier and Chevalier, 2008), administered mainly via injection into the knee, hip and shoulder. They are viscous lubricants whose prevailing action is supplementary and cushioning.

The viscosupplementation replaces the (usually degraded) hyaluronic acid of the synovial fluid of the joints of the pa- tients affected by osteoarthritis.

The hyaluronic acid is mostly used to inject the knee in or- der to treat gonarthrosis.

Nevertheless, the members of the EULAR (European League Against Rheumatism) Committee for clinical trials on osteoarthritis of the knee met in 1998 and came to the con- clusions that the hyaluronic acid and symptomatic slow-ac- ting antiarthritic drugs have modest efficacy in gonarthro- sis. Moreover, they stated that the patients who may benefit from this therapy are hardly identifiable and that pharma- coeconomic data are uncertain. The opinion of 21 experts has placed the use of the hyaluronic acid for the treatment of gonarthrosis in 13th place out of 23 entries (Pendleton et Al., 2000).

  • Since 2010, also the treatment of algic/degenerative dis- eases of the musculoskeletal system takes advantage of the

use of the injectable Collagen* Medical Devices (MDs) (Gu- na Laboratories, Milan – Italy).

The Collagen MDs can be used alone (e.g. MD-Lumbar: low back pain with high arthritic imprint), or – more frequently variously mixed according to the patient’s clinical and func- tional needs (e.g. MD-Lumbar + MD-Neural: low back pain with algic nerve imprint; MD-Lumbar + MD-Muscle: low back pain with prevailing myo-fascial imprint).

The Collagen MDs are applied locally through:

  1. periarticular injections
  2. intra-articular injections (obviously in the joints allo- wing a clear intra-articular approach: knee, hip, shoul- der)
  3. subcutaneous and/or intradermal injections (in trig- ger points, in spontaneously painful points, in points whe- re average digitopressure causes pain, in local acupunc- ture points, etc.).

or systemically:

– intramuscular injections (into muscle trigger points), and in supportive treatment (mainly at home).

The 13 Collagen Medical Devices are produced from der- mal tissue of swine origin (trophism) + ancillary excipients of natural origin allowing an efficient and specific positio- ning on site (tropism).

The ancillaries were selected according to different criteria such as: traditional use, dedicated literature, clinical eviden- ce, quality profiles, etc.

The swine’s dermal tissue contains » 50% of collagen Type I (Gly = 22.8%; Pro = 13.8%; OH-Pro = 13%).

  • The purpose of the in situ injections of the Collagen MDs is essentially structural.

From 2010 to 2012 10 clinical trials on humans were car- ried out, involving most of the treatable anatomical districts with Collagen MDs: 3 gonarthrosis, 1 patello-femoral arth- ropathy, 2 coxarthrosis, 2 shoulder pain, 1 PMID (Painful Mi- nor Intervertebral Dysfunctions) of cervical rachis, 1 acute lumbar back pain.

  • In the following pages it is presented the synopsis of the experiments; the Authors’ conclusions of the 10 trials are faithfully reported.

►     EFFICACY AND SAFETY OF THE GUNA MDs INJEC- TIONS IN THE TREATMENT OF OSTEOARTHRITIS OF THE KNEE

Authors: Rashkov R., Nestorova R., Reshkova V.

  • Clinical Assessment presented at the Bulgarian National Congress of Rheumatology – Pravets (October 2011), at the European Congress on Osteoporosis and Osteoarthritis – Bor- deaux (F) (March 2012), and at the 3rd Bulgarian National Congress on Osteoporosis and Osteoarthritis – Sandanski (No- vember 2012).

Experimental sites: Rheumatology Clinic of the Medical University of Sofia, Rheumatology Center St. Irina (Sofia – Bul- garia).

Pathologies considered: symptomatic gonarthrosis (Kellgren- Lawrence* Rx grade II-III) without aftereffects of the periar- ticular soft tissues.

Outcomes

  1. assessment of pain at rest and during movement before and after treatment;
  2. assessment of the Lesquesne Algofunctional Index** be- fore and after treatment;
  3. effectiveness of the MDs used (evaluation by the patient and by the physician).

Inclusion/exclusion criteria: stated.

Patients enrolled: 28 (12 M, 16 F, aged 55-70).

Treatment: MD-Knee, 1 ampoule + MD-Muscle, 1 ampou- le: 2 intra-articular injections/week for 2 consecutive weeks

+ 1 intra-articular injection/week for the next 6 weeks (total: 10 injections in 2 months).

Results

Statistically significant reduction of pain (VAS *** = 0-10) at rest (maintained even 30 days after the end of the therapy) and during movement (VAS = 0-10) (maintained even after the end of the therapy) (TABLES. 1, 2). Statistically significant improvement of the indicators of the Lesquesne Algofunctional Index (TABLES 3, 4).

Authors’ conclusions:

  1. Intra-articular administration of MD-Knee + MD-Muscle in gonarthrosis Kellgren-Lawrence Rx grade II-IIII reduces si- gnificantly pain at rest and during movement and improves the functional activity of patients, who assessed excellent + good in 65% of cases.
  2. The effect persists even after treatment.

There were no adverse effects in any case.

► EFFECTIVENESS OF THE GUNA COLLAGEN MDs INJECTIONS   IN   PATIENTS   WITH  GONARTHROSIS, ANALYSED CLINICALLY AND WITH ECOGRAPHY

Authors: Nestorova R., Rashkov R., Reshkova V., Kapandjieva N.

  • Clinical Assessment presented at the 9th Central Congress of Rheumatology (CECR 2012) 3rd Annual Meeting of the Polish Rheumatologists – Krakow (Poland) (September 2012), and at the European Congress on Osteoporosis and Osteoarthritis – Bordeaux (F) (March 2012).

Article published in Rp./Orthopedic 2011/3, Medicine and Sport 2011/4 and PRM 2012; 37-39.

Experimental sites: Rheumatology Center St. Irina (Sofia); Rheumatology Clinic MBAL “St. Ivan

Experimental sites: Rheumatology Center St. Irina (Sofia);

Rheumatology Clinic MBAL “St. Ivan Rilski” (Sofia); Rheu- matology Center MBAL – Rousse (Bulgaria).

Pathologies considered: symptomatic gonarthrosis (Kellgren-Lawrence* Rx grade III-IV) with aftereffects of the periarti- cular soft tissues.

Outcomes

  1. assessment of pain at rest and during movement (VAS = 0-10; Lesquesne Algofunctional Index**);
  2. ecographic evaluation before treatment, after 30 days and at the end of the treatment;
  3. evaluation of effectiveness of the MDs used.

Inclusion / exclusion criteria: stated.

Patients enrolled: 35 (aged 62-79).

Treatment: MD-Knee, 1 ampoule + MD-Matrix, 1 ampou- le: peri-articular injections / week for 2 consecutive weeks

+ 1 peri-articular injection /week for 6 more weeks (total: 10 injections in 2 months).

Results

  1. Statistically significant reduction of pain (VAS*** = 0-10) at rest (maintained even after the end of treatment) and du- ring movement (maintained even 30 days after the end of treatment) (TABB. 5, 6).
  2. Statistically significant improvement of all indicators of the Lequesne Algofunctional Index (examples in TABB. 7, 8).
  3. 60% of patients do not have any edema; 30% achieved a reduction of edema

– Authors’ conclusions:

  1. ) Intra-articular administration of MD-Knee + MD-Matrix in gonarthrosis Kellgren-Lawrence Rx grade II-IIII reduces si- gnificantly pain at rest and during movement and improves the functional activity of patients.
  2. The effectiveness of treatment was evaluated as excellent

+ good in 68% of patients and 72% of physicians.

  • Periarticular edema improves in 90% of cases as proven by ecography.
  • The effect is maintained even after treatment.

The analysed MDs have a very high safety profile.

►     APPLICATION AND ASSESSMENT OF EFFICACY OF COLLAGEN INJECTIONS GUNA MDs IN GONARTHRO-SIS

Author: Boshnakov D.

– Clinical Assessment presented at the XIX Days of Bulga- rian Orthopedics and Traumatology, Tryavna, (September 2012).

Experimental sites: Saint Anne University Hospital, Varna(Bulgaria).

Pathologies considered: gonarthrosis.

Outcomes

  1. assessment of pain at rest and during movement (VAS = 0-10);
  2. assessment of Lequesne Algofunctional Index for:

a.pain when walking; b.maximum walking distance (in me- ters); c.daily activities;

3. assessment of efficacy of treatment from the patient’s view- point.

Inclusion/exclusion criteria: unstated.

Patients enrolled: 14 (8 M; 6 F; aged 51-72).

Treatment: MD-Knee, 1 ampoule + MD-Muscle, 1 ampou- le: 2 intra-articular and peri-articular injections/week for 2 consecutive weeks + 1 intra-articular and peri-articular in- jection/week for the following 6 weeks (total: 10 treatments in 2 months).

Results

  1. Pain at rest: VAS from 2.85 at treatment start (moderate pain) to 0.95 at the end of treatment (no pain) (TAB. 9).
  2. Pain when moving: VAS from 7.3 at treatment start (un- bearable pain) to 3.5 at the end of treatment (moderate/se- vere pain) (TAB. 10).
  3. Lequesne Algofunctional Index: from 1.6 at treatment start to 1.1 at the end of treatment (TAB. 11); maximum walking dis- tance from 100-300 meters before treatment (5.2 score) to 400-700 meters after treatment (3.6 score) (TAB. 12).

Author’s conclusions:

  1. Intra-articular injections of Collagen MDs improve: a) lo- calized pain; b) pain at movement; c) joint mobility.
  2. Intra- and peri-articular injections improve the patients’ functional activity and quality of life.
  3. The injections of Collagen MDs are a new and effective method to treat gonarthrosis.

►     PATELLO-FEMORAL CHONDROPATHY TREATED WITH MD-KNEE + ZEEL® T TRANSMITTED WITH O2 VERSUS

NIMESULIDE + CHONDROITIN SULPHATE

Author: Posabella G.

  • Clinical trial presented at the Meeting Sport Medicine, the challenge for Global Health – Rome (September 2012).

Article published in La Med. Biol., 2011/3; 3-11, and in PRM 2012/1; 3-10.

Pathologies considered: patella-femoral chondropathy stage I-II-III according to Kellgren-Lawrence.

Outcomes

assessment of clinical response (analytical WOMAC****; Le- quesne Index) after administering MD-Knee + Zeel® T trans- mitted with hyperbaric O2 (Group A) versus nimesulide + chondroitin sulphate (Group B).

Inclusion/exclusion criteria: unstated; randomization.

Patients enrolled: Group A, 20 [15 M, 5 F; average age 46.4 years (31-66)]; Group B, 20 [15 M, 5 F; average age 46.9 years (28-65)].

Treatment: Group A – MD-Knee, 1 ampoule + Zeel® T, 1 ampoule, both applied onto the knee skin and transmitted with hyperbaric O2, 1 application/week.

Group B – nimesulide in 100 mg sachets + Condral (galaco- tosaminoglucuronoglycan sulphate sodium salt) 400 mg, 1/die per os.

Results

  • After the first week of treatment the patients of both groups (A; B) showed a reduction of the total WOMAC score com- pared to baseline, even if not statistically significant.

WOMAC Group A = 50 points – Lequesne Index = 17.05 WOMAC Group B = 54 points – Lequesne Index = 17.9

-Second week

WOMAC Group A = 47 points WOMAC Group B = 53 points

-Third week

WOMAC Group A = 44 points WOMAC Group B = 51 points

-Sixth week (1st follow-up) WOMAC Group A = 41 points WOMAC Group B  = 50 points

-Twelfth week (2nd follow-up)

WOMAC Group A = 39 points – Lequesne Index = 10.4 WOMAC Group B = 47 points – Lequesne Index = 15.3

Author’s conclusions:

  1. Both Groups of patients (A; B) showed a considerable im- provement of pain and functional limitation.
  2. The data show a more rapid clinical and functional im- provement in the patients of Group A compared to the pa- tients of Group B.
  3. No side effects in the patients of Group A.

– For comparative analysis of the 4 clinical trials on the osteoarthritis of the knee see TAB.13.

►     INTRA-ARTICULAR ADMINISTRATION OF MD-HIP IN 7 PATIENTS AFFECTED BY HIP OSTEOARTHRITIS UNRE-

SPONSIVE TO VISCOSUPPLEMENTATION.

-SIX MONTH MULTICENTER TRIAL

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 Rheu-

matology – San Pietro Fatebenefratelli Hospital, Rome. Pathologies considered: osteoarthritis X-Ray I-III stage ac- cording to Kellgren-Lawrence affecting the hip joint unre- sponsive to viscosupplementation with hyaluronic acid (6 pa- tients) or hylan (1 patient) (2 ultrasound guided injections at least).

Outcomes

  1. assessment of efficacy using VAS scale and Lequesne al- gofunctional 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 gui- ded intra-articular injection.

Results

  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 (af- ter 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.

►     EFFICACY OF INJECTIONS MD-HIP AND MD-MATRIX IN TREATMENT OF COXARTHROSIS.

  • CLINICAL AND ULTRASONOGRAPHIC EVALUATION

Author: Tivchev P.

Article published in Bulgarian Journal of Orthopaedics and Traumatology. Vol 49/2012; 123-8

Experimental sites: Serdika Hospital (Sofia); Deva Maria Hospital (Bourgas – Bulgaria)

Pathologies considered: x-Ray stage I-II-III hip osteoarthritis according to Kellgren-Lawrence.