Clinical Evidence

Question 1

What is the Level 1 Regeneten study from 2023 from Spain?

Answer 1

Ruiz Iban Study

Question 2

What makes the Iban study level 1?

Answer 2

Randomized
Triple Blinded
Multi-Centered

Question 3

Describe the Iban study:
# of patients?
Size of tears?
Types of repairs?

Answer 3

122 Patients
1-4cm tears
Double Row Repair vs Double Row Repair plus Regeneten

Question 4

Describe the follow up from the Iban study

Answer 4

1 Year follow up with MRI

Question 5

Describe the results from the Iban study

Answer 5

25% retear rate vs. 8% retear rate
3X decrease in rates for retear
Significantly better tendon integrity

Question 6

What does the Van Kampin paper show when 2mm of tendon are added to a PTT?

Answer 6

40% decrease in stresses and strains on the tendon

Question 7

Which paper shows benefits of adding 2mm of tendon to PTTs?

Answer 7

Van Kampin paper

Question 8

Year and name of our important biopsy study?

Answer 8

Arnozky 2017

Question 9

What did Arnozky biopsy paper show?

Answer 9

Regeneten was completely resorbed and replaced by new tendon tissue

Question 10

Results of Arnozky biopsy paper

Answer 10

5 weeks - blood vessels integrating and collagen remodeling
3 months - Collagen remodeled. Into organized tissue
6 months - Regeneten fully resorbed. 2mm new tissue

Question 11

2024 Camacho paper shows what differences between repair and Regeneten cuffs?

Answer 11

1. Scar tissue vs highly aligned tissue - better tendon quality
2. Faster return to work (163 days to 90 days)
3. Less pain - higher patient satisfaction

Question 12

What is the rotator cable

Answer 12

Thicker piece of tissue that runs through the rotator cuff