Achilles Non-SNIS REGENETEN

Conditions

• Complete Mid-portion Achilles Rupture

Eligibility Criteria

Sex

ALL

Age

21 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• REGENETEN — DEVICE
  The REGENETEN Bioinductive Implant is a scaffold made from highly purified type I collagen fibers. Following fixation, using its efficient and suture-free technique, the REGENETEN Implant is resorbed and replaced by a new layer of tendon-like tissue within 6 months increasing tendon thickness, and creating an environment conducive to healing.

Study Details

The proposed study addresses this gap by prospectively evaluating patient-reported outcomes, imaging endpoints, and safety through 12 months after BCI-augmented repair in IAT and MSR patients. The purpose is to evaluate clinical outcomes (effectiveness) following the use of REGENETEN to augment Achilles tendon surgical procedures.

Key Dates

First listed

Oct 9, 2026

Start date

Aug 3, 2026

Status verified

Oct 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

50 participants (estimated)

Arms

• Arm: Krakow sutured, bundle-to-bundle repair
  Krakow sutured, bundle-to-bundle repair for mid-substance primary Achilles rupture with REGENETEN augmentation. Fixation of REGENETEN implant to be completed with tendon anchors.
• Arm: Achilles tendon reconstruction
  Achilles tendon reconstruction, with or without concomitant calcaneoplasty/bursectomy for insertional Achilles tendinopathy. Fixation of REGENETEN implant to be completed with tendon anchors.

Primary Outcome Measure

American Orthopaedic Foot & Ankle Society (AOFAS) ankle/hindfoot score [ Time Frame: 12 months post surgery ]

Locations (1)

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