hyaluronic acid in shoulder

1. 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

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

4. Recent Literature: JSES 2013

5. VISCOSUPPLEMENTATION: Mode of Action
Still lots of space for clinical research

6. In press

7. PATIENTS & METHODS:
 100 consecutive patients suffering with cuff disorders
 Neer’s Modified Classification: diagnosed
Bursitis - Tendonitis
Partial Tear
Full thickness tear (No OA)
Cuff Tear Arthropathy
with plain radiographs & MRI

8. PATIENTS & METHODS:
EXCLUSION CRITERIA
Rheumatoid 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.

9. • 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).

10. ENDPOINTS
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

11. PATIENTS & METHODS
 Follow up:
–
–
–
–
–
Before therapy
Day 15,
Day 30,
Day 45,
Day 90.
 Evaluation scores:
1.
2.
3.
Statistical method:
VAS PAIN
Oxford Shoulder Score
Constant-Murley Score
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 .

12. RESULTS: Safety Assessment
• 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:
– Headache:
–
–
Swollen mass around the needle hole:
–
•
Ecchymoses around the injection site:
Fainting due to a vasovagal reaction:
13 episodes (9/13 in Grade IV patients –aged people)
5 episodes.
3 episodes
1 case
1 case
Side effects in line with the current literature (Gigante et al 2011)

13. RESULTS: Demography and ROM assessment
Characteristics of the
N° of patient per
Mean age
group
Grade of lesion /
rotator cuff lesion
ROM
ROM
Pre-treatment ±
y.o. ± sd
sd
day 90 ± sd
44.6± 4.6
56.2°±15.3°
167.4°± 5.4°
46.7± 7.4;
123.2°±22.1°
158.9°±.57°
56.2± 9.2
101.4°±12.5°
107.1°±18.9°
76.1±3.1
Male/Female
55.3°±14.6°
66.4°±14.9°
Groups of patient
Bursitis. No cuff Lesion.
Acute/Chronic
Grade 1/Group1
No. 38
Inflammation.
Subacromial
M= 24 F= 14
impingement.
No. 32
Grade 2/Group 2
Partial tear
M= 17 F= 15
No. 16
Grade 3/Group 3
Complete tear. No OA
M= 6
Grade 4/ Group 4
Massive tear and diffuse
glenohumeral OA.
F= 10
No. 14
M= 7
F= 7

14. RESULTS
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

15. 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.

16. 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

17. 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

18. CONCLUSION
…Viscosupplementation using a low-medium hyaluronate (as Sinovial®):
1. useful treatment option for patients with bursitis (grade 1)
1. used in partial tears (grade 2) to attenuate the inflammatory process,
2.
In cuff tear arthropathy (grade 4), to defer the intervention of shoulder arthroplasty or inoperable cases
3.
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).
Overall: Safe and well tolerated
(as also confirmed by Chevalier & Migliore: Safety and tolerabilty of intra articular HA); 2013 in press

19. Portonovo – Ancona
ITALY