isiat sinovial ibsa

RUOLO FISIOPATOLOGICO DELLE CELLULE STAMINALI MESENCHIMALI (PSORIASI:

EFFECT OF SUBACROMIAL INJECTIONS OF HYALURONAN ON DIFFERENT GRADES OF ROTATOR CUFF LESION: A

PROSPECTIVE STUDY

Alberto Busilacchi M.D.Clinical Orthopaedics

Università Politecnica delle Marche – Ancona - ITA

Disclosure

Dr. Alberto Busilacchi M.D. is consultant for IBSA.Financial support was received for the divulgation of the present study

Recent Literature: JSES 2013

VISCOSUPPLEMENTATION: Mode of Action

Anti-Infiammatory & Analgesic Effect

Neo-synthesis

HA

Viscoelastic Properties

Restoration

Still lots of space for clinical research

E ff e c t O f S u b a c r o m i a l I n j e c ti o n O f H y a l u r o n a n O n D i ff e r e n t G r a d e s O f R o t a t o r C u ff L e s i o n : A P r o s p e c ti v e S t u d y .

E u r o p e a n J o u r n a l o f I n fl a m m a ti o n 2 0 1 3 ( i n p r e s s )

In press

PATIENTS & METHODS:

Bursitis - Tendonitis

Partial Tear

Full thickness tear (No OA)

Cuff Tear Arthropathy

100 consecutive patients suffering with cuff disorders

Neer’s Modified Classification: diagnosed with plain radiographs & MRI

EXCLUSION CRITERIARheumatoid arthritis, amiloidosis, chondrocalcinosis, gout,

rheumatological disesases

Trauma episodes on the shoulder in anamnesis

Adhesive capsulitis / calcific tendonitis

Diabetes

Major depressive syndrome

Previous sub-acromial injection therapies (any drug)

Age under 30 & over 80 y.o.

Shoulder Instability anterior, posterior, multidirectional, SLAP lesions.

PATIENTS & METHODS:

HA INJECTION TECHNIQUE

• The injective cycle consisted of 3 subacromial injections, repeated every 15 days for 3 times.

• Injections performed by the antero-lateral way, US guided (IU22- Philips- The

Netherlands).

• Sinovial® (IBSA) 0.8% - 16mg/2ml was used: obtained by biofermentation and purification processes (MW 800-1200kD).

1. To evaluate the pain reduction 15 days after the end of the injections cycle (day 45 from first injection), relative to baseline .

2. maintenance of pain relief measurements in a medium term (day 90) .

3. Additional end points included improvement in terms of global assessment by the patient and the level of functional improvement based on the range of motion.

4. Safety assessment

ENDPOINTS

Follow up:– Before therapy – Day 15, – Day 30, – Day 45, – Day 90.

Evaluation scores: 1. VAS PAIN2. Oxford Shoulder Score 3. Constant-Murley Score

PATIENTS & METHODS

Statistical method: For each effectiveness variable the comparisons between cuff tears grades were performed by means of an analysis of covariance for repeated measures model, considering the baseline value of each variable as covariate .

• Overall, the treatment was well tolerated.• No shoulder infections occurred during the observational period.• No systemic adverse events observed.

• Common side effects were:– Pain at the injection site: 13 episodes (9/13 in Grade IV patients –aged people)

– Headache: 5 episodes. – Ecchymoses around the injection site: 3 episodes – Swollen mass around the needle hole: 1 case – Fainting due to a vasovagal reaction: 1 case

• Side effects in line with the current literature (Gigante et al 2011)

RESULTS: Safety Assessment

Grade of lesion / Groups of patient

Characteristics of the

rotator cuff lesion

N° of patient per group

Male/Female

Mean age

y.o. ± sd

ROM Pre-treatment ±

sd

ROM

day 90 ± sd

Grade 1/Group1

Bursitis. No cuff Lesion. Acute/Chronic Inflammation. Subacromial impingement.

No. 38

M= 24 F= 14

44.6± 4.6 56.2°±15.3° 167.4°± 5.4°

Grade 2/Group 2 Partial tear

No. 32

M= 17 F= 15

46.7± 7.4; 123.2°±22.1° 158.9°±.57°

Grade 3/Group 3 Complete tear. No OA

No. 16

M= 6 F= 10

56.2± 9.2 101.4°±12.5° 107.1°±18.9°

Grade 4/ Group 4Massive tear and diffuse glenohumeral OA.

No. 14

M= 7 F= 7

76.1±3.1 55.3°±14.6° 66.4°±14.9°

RESULTS: Demography and ROM assessment

Primary endpoint. • In grades I and II, at day 45 of FU, significant reduction of VAS and increase of

Constant-Murley and OSS was recorded. • In grade III not a meaningful improvement of the shoulder function as well

as pain relief.• In IV grade benefits were recorded for the first 45 days, while OSS and

Constant did not show any improvement.

Secondary endpoint• Grade I and II. Excellent global conditions. Full ROM recovery• Grade III: Poor improvements in global conditions. Poor ROM improvement• Grade IV: improvements in global conditions. Poor ROM improvement

RESULTS

RESULTS: VAS PAIN

VAS decreased significantly for Grade 1 and Grade2 as Grade 4 of disease, until the end of HA injective administration. At day 45, following a period of pain reduction, in Grade 3 15 days after the last injection patients report an increasing pain.

RESULTS: Oxford Shoulder Score

By OSS evaluation, as patient’s global assessment, the HA injections were effective on bursitis and partial tear. In grade 3 at 90 days no benefits have to be reported. In Grade 4 a benefit was reported, but not meaningful in comparison with Grades 1 and 2

RESULTS: Constant - Murley

The CS assessed the functional improvement of the shoulder in all the 4 grades of cuff disease. However, the grades 3 and 4, starting from the end of injective treatment showed a significant reduction, as demonstration of a temporary effect of the injected molecule

1. useful treatment option for patients with bursitis (grade 1)

2. used in partial tears (grade 2) to attenuate the inflammatory process,

3. In cuff tear arthropathy (grade 4), to defer the intervention of shoulder arthroplasty or inoperable cases

4. In full thickness lesions (grade 3) the efficacy is very poor (grade 3 is not an indication for a HA injection therapy, even in view of a reconstructive surgery).

CONCLUSION

…Viscosupplementation using a low-medium hyaluronate (as Sinovial®):

Overall: Safe and well tolerated (as also confirmed by Chevalier & Migliore: Safety and tolerabilty of intra

articular HA); 2013 in press

THANK YOU

Portonovo – Ancona ITALY