Total Tendon Repair PROSPECTIVE, OPEN-LABEL, MULTICENTER, OBSERVATIONAL STUDY TO ASSESS THE EFFICACY OF TENDOACTIVE IN PATIENTS WITH TENDINOPATHY

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1 Total Tendon Repair PROSPECTIVE, OPEN-LABEL, MULTICENTER, OBSERVATIONAL STUDY TO ASSESS THE EFFICACY OF TENDOACTIVE IN PATIENTS WITH TENDINOPATHY

2 PARTICIPATING CENTERS

3 METHODS OBJECTIVES: Primary objective: To assess the effect of Tendoactive on the clinical symptoms of tendinopathies Secondary objectives: To assess the effect of Tendoactive on tendon structure To quantificate the consumption of analgesics during the treatment with Tendoactive To assess the satisfaction of patients treated with Tendoactive

4 METHODS Study population: 98 patients with tendinopathy (2 Achilles tendon, 4 patellar tendon and 2 epicondylitis) were included Study duration: months (1 control/month) Efficacy outcomes Functional score (VISA-A, VISA-P, PRTEE) Pain (VAS) during rest/activity Ultrasonographic tissue characterization Patient s satisfaction Analgesics consumption Safety: Adverse events were recorded

5 Inclusion criteria: METHODS Men and non-pregnant women > 18 years old Patients with tendinopathy in Achilles tendon, patellar tendon or epicondylitis (Diagnosis based on clinical examination showing a painful thickening of the tendon, and confirmed by ultrasonography: local thickening of the tendon, irregular tendon structure with hypoechoic areas and irregular fiber orientation) Exclusion criteria: Patients < 18 years old Known presence of a pregnancy Clinical suspicion of neurological disorder Clinical suspicion of internal disorders (spondyloarthropathy, gout, hyperlipidemia, rheumatoid arthritis and sarcoidosis)

6 PATIENTS Included (ITT) = 98 Achilles = 2 Epicondylitis = 4 Patellar= 2 Dropouts = 28 Achilles = 11 Epicondylitis = 6 Patellar= patients didn t complete the months treatment PP population = 7 Achilles = 21 Epicondylitis = 28 Patellar= 21

7 BASELINE CHARACTERISTICS ACHILLES EPICONDYLITIS PATELLAR Age (years) 49,2 47,7 9, Sex (n, M/W) 1/8 14/14 1/8 BMI (Kg/m 2 ) 24,1 25,6 2,1 Functional Score (-1) 6, 51,25 58,25 VAS during rest (-1),,4 4,1 VAS during activity (-1) 5,6 6,5 6, Activity level (-1) 4,5 5, 5,6 Bilateral thickness of the affected tendon (mm) 9,5 7,7 1,4 Paratenon blurring (n, /1/2/) 6/7/4/1 1/12/2/1 8/8// Heteroechogenicity (n, /1/2/) 5/6/6/1 4/11/6/ /11/2/4 Hipoechogenicity (n, /1/2/) 4/7/8/ 4/4/8/1 5//7/ Neovascularization (n, /1/2/) 7/8/5/ 7/1/5/5 8/5//4 Isolated intratendinous rupture (n) 5 1 4

8 cm (-1) cm (-1) RESULTS: PAIN (VAS) 5. VAS during rest ACHILLES TENDINOPATHY VAS during activity p<.5 compared to baseline

9 Score (-1) Score (-1) RESULTS: FUNCTIONAL SCORE ACTIVITY LEVEL VISA-A ACHILLES TENDINOPATHY p<.5 compared to baseline Activity level 2..

10 cm (-1) cm (-1) RESULTS: PAIN (VAS) 5. VAS during rest PATELLAR TENDINOPATHY VAS during activity p<.5 compared to baseline

11 Score (-1) Score (-1) RESULTS: FUNCTIONAL SCORE ACTIVITY LEVEL 1 9 VISA-P PATELLAR TENDINOPATHY Activity level p<.5 compared to baseline

12 cm (-1) cm (-1) RESULTS: PAIN (VAS) 5. VAS during rest EPICONDYLITIS VAS during activity p<.5 compared to baseline

13 Score (-1) Score (-1) RESULTS: FUNCTIONAL SCORE ACTIVITY LEVEL 8 PRTEE (inversely scored) EPICONDYLITIS Activity level p<.5 compared to baseline

14 % of change RESULTS: ULTRASONOGRAPHIC ASSESSMENT ACHILLES TENDINOPATHY Thickness of the affected tendon -2 p<.5 compared to baseline

15 RESULTS: ULTRASONOGRAPHIC ASSESSMENT ACHILLES TENDINOPATHY Paratenon blurring Heteroechogenicity Hipoechogenicity Neovascularization p<.5 compared to baseline

16 % of change RESULTS: ULTRASONOGRAPHIC ASSESSMENT PATELLAR TENDINOPATHY. Thickness of the affected tendon p<.5 compared to baseline

17 RESULTS: ULTRASONOGRAPHIC ASSESSMENT PATELLAR TENDINOPATHTY Paratenon blurring Heteroechogenicity Hipoechogenicity Neovascularization p<.5 compared to baseline

18 % of change RESULTS: ULTRASONOGRAPHIC ASSESSMENT EPICONDYLITIS. Thickness of the affected tendon p<.5 compared to baseline

19 RESULTS: ULTRASONOGRAPHIC ASSESSMENT EPICONDYLITIS Paratenon blurring Heteroechogenicity Hipoechogenicity Neovascularization p<.5 compared to baseline

20 RESULTS: ULTRASONOGRAPHIC ASSESSMENT Thickness of the achilles tendon L: Baseline (.67 cm). R: Final (.6 cm) Achilles tendon showing hetero-hypoechogenecity and paratenon blurring Patellar tendon showing neovascularization (Power Doppler)

21 RESULTS: ANALGESICS CONSUMPTION ACHILLES TENDINOPATHY EPICONDYLITIS % of patients consuming analgesics % of patients consuming analgesics 2 SI YES NO 2 SIYES NO NO % of patients consuming analgesics PATELLAR TENDINOPATHY 2 SIYES NO NO Results are presented as the percentage of patients taking at least one dose of analgesics within the previous month to each visit

22 RESULTS: PATIENT S SATISFACTION ACHILLES TENDINOPATHY Patient s satisfaction EPICONDYLITIS Patient s satisfaction Muy Verybien good Muy Verybien good Bien Good Regular So-so 2 Mal Bad 6 9 Bien Good Regular So-so Mal Bad PATELLAR TENDINOPATHY Patient s satisfaction Muy Verybien good Bien Good 2 Regular So-so 6 9 Mal Bad

23 CONCLUSIONS EFFICACY Treatment with Tendoactive in patients with tendinopathy of achilles tendon, patellar tendon or epicondylitis: - Improves pain and tendon function - Favors structural recovery of the tendon - Reduces analgesics consumption - Favors the return to activity The global patient s assessment of the treatment was very good SAFETY No adverse event related to the treatment was reported during the study Pending for publication in Apunts Medicina de l Esport Indexed scientific journal dedicated to sports medicine, containing original research articles in English language, and subjected to an anonymous external peer review process.