Presentation at the Western Orthopaedic Association Annual Meeting 2012 - Collagen Stuffed Sutures Enhance Healing of Full-Thickness Rotator Cuff Tears

1. Collagen Stuffed Sutures Enhance
Healing of Full-Thickness Rotator
Cuff Tears
Alan M. Hirahara, M.D., FRCS(C)
Private Practice
Sacramento, CA USA
Medical Director Team Physician Consultant
Sacramento State Athletics Sacramento River Cats Oakland A’s
MiLB - AAA

2. Objective of Study
• To evaluate the clinical effectiveness of a new
collagen stuffed suture on full-thickness
rotator cuff repairs

3. Introduction
• No other study has evaluated the clinical effectiveness
of a collagen stuffed suture on full-thickness rotator cuff
repairs
• Mazzocca et al showed that collagen-coated
polyester/polyethylene suture stimulates adhesion,
proliferation alkaline phosphatase and protein synthesis
more than uncoated sutures
– Therefore, may aid in the tendon to bone incorporation process
critical to rotator cuff repair
Mazzocca et al. JSES 2007; 16(5): S222-30.

4. Scanning Electron Microscopy
Control suture exhibiting Collagen fibers appear
smooth surfaces 1000X Mag
as thread-like structures
for all images
Courtesy of Gus Mazzocca, U Conn

5. Study Design
• Case-control study
• Collection period: 1/10 – 12/11
• Pain scores, ASES scores taken every month for 6
months
– ROM measured pre-op and monthly for 3 months post
– Date of discharge and date of return to work were noted

6. Study Design
• Inclusions:
– All patients requiring a full-thickness RC repair
• Exclusions:
– any post-operative trauma
– non-compliance with physical therapy protocol
• Failure to heal:
– Evaluated any symptoms 4-6 months post-op with repeat MRA
or surgery

7. RCR with Collagen Stuffed Suture

8. Surgical Technique: Control Group
• SutureBridge technique
• 5.5 mm biocomposite full
thread Corkscrew anchors
& 3.5 mm biocomposite
PushLock anchors
• SpeedBridge technique
• 4.5 mm vented SwiveLock
anchors with FiberTape

9. Patient Data
Study Group Control Group
• 56 patients • 45 patients
• 31 male / 26 female • 25 male / 20 female
• Age range: 25 – 86 years • Age range: 34 – 78 years
• Age average: 58.83 years • Age average: 56.64 years

10. Results
Pain Scores ASES Scores
p = NS p = 0.02 p = NS p = 0.02
7.0 90.0
80.0
6.0
70.0
5.0
60.0
4.0 50.0
3.0 40.0
30.0
2.0
20.0
1.0
10.0
0.0 0.0
Pre-op Month Month Month Month Month Month Pre-op Month Month Month Month Month Month
1 2 3 4 5 6 1 2 3 4 5 6
 Control Group: n = 45
 Study Group: n = 56

11. Range of Motion
160.0
140.0
120.0
100.0
Control Flexion
Degrees
80.0 Study Flexion
Control ER
60.0
Study ER
40.0
20.0
0.0
Initial Visit 1 Month 2 Month 3 Month
No Significant Difference Between the 2 Groups

12. Results – Return to Work
p = 0.03
250.0 200.5
200.0
150.0
81.2
Days
100.0
50.0
0.0
Control Group Study Group

13. Results – Days to Discharge
p = 0.0004
176.8
180.0
160.0
140.0
109.0
120.0
100.0
Days
80.0
60.0
40.0
20.0
0.0
Control Group Study Group

14. Results - Failures
6 • Control Failures
6
• 2 - small
5 • 2 - moderate
4
• 1 - large
3
• 1 - massive
3
2
1
• Study Failures
0
• 1 - moderate
• 2 - massive
Control Group Study Group
No Significant Difference Between the 2 Groups

15. Results
• Significant Difference in:
– Pain scores at 6 months
– ASES scores after 5 months
– Time to return to work by 119.3 days
– Time to discharge by 67.8 days
• No significant difference in failure rate
– 13.3% to 5.3%

16. Integration
• No evidence of integration of the suture into
the tendon on re-evaluation

17. Discussion
• Collagen stuffed suture appears to enhance healing of rotator cuff
repairs
– Significantly improved function & less pain by 5 & 6 months
– Patients were discharged and returned to work faster
– Fewer failures in the study group but not statistically significant
• Those that did fail tended to be larger in size in the study group
• Further study is needed on the best mode of use of collagen with
sutures and anchors
• Will require a randomized controlled trial to confirm the results

18. Conclusion
• Collagen stuffed sutures may promote
healing of rotator cuff tears over standard
sutures

19. Thank You