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A device for zone-II flexor tendon repair. Surgical technique
Brian W Su1, Michael Solomons, Andrew Barrow
1Columbia University Medical Center, New York, NY, USA.
The Journal of Bone and Joint Surgery. American Volume
|March 3, 2006
Summary
The Teno Fix device shows lower rupture rates for flexor tendon repair compared to sutures. Functional outcomes are similar, making it a safe option, especially for non-compliant patients.
Area of Science:
- Orthopedic Surgery
- Biomaterials Science
- Reconstructive Surgery
Background:
- The stainless-steel Teno Fix device offers improved biomechanical properties over traditional suture repair for flexor tendons.
- Previous studies in canine models indicated good tolerability and efficacy.
Purpose of the Study:
- To clinically compare the efficacy and safety of the Teno Fix device against conventional suture repair for zone-II flexor tendon injuries.
Main Methods:
- A randomized clinical trial involving 67 patients with 85 injured digits (34 Teno Fix, 51 suture repair).
- Patients underwent repair followed by a standardized rehabilitation protocol with active flexion at four weeks.
- Outcomes assessed over six months included range of motion, Disabilities of the Arm, Shoulder and Hand (DASH) score, strength, pain, swelling, and neurologic recovery.
Main Results:
- Teno Fix repairs demonstrated significantly lower rupture rates (0% vs. 17.6%, p < 0.01) compared to suture repairs.
- No significant differences were observed in range of motion, DASH scores, strength, pain, swelling, or neurologic recovery between the groups.
- One Teno Fix device migrated due to infection; tendon size and exposure were limiting factors in some cases.
Conclusions:
- Teno Fix is a safe and effective option for flexor tendon repair when tendon size and surgical exposure are adequate.
- It offers reduced rupture rates and comparable functional outcomes to suture repair, particularly beneficial for patients with rehabilitation compliance challenges.
