An observational study in Complete Mid-portion Achilles Rupture, sponsored by OrthoCarolina Research Institute, Inc.. Enrolling by invitation at 1 site in United States. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by OrthoCarolina Research Institute, Inc. · Observational
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.
Achilles tendon pathology is a common musculoskeletal condition, affecting approximately 6% of the general population. Mid substance ruptures (MSR) have a reported incidence rate of approximately 2.1 per 100000 people, and one third of all instances of Achilles tendon pain have been attributed to Insertional Achilles tendinopathy (IAT).
Although patients undergoing standard of care repair of MSR generally report good clinical outcomes, and re-rupture rates following primary repair of a mid-substance tear are cited to range 2-3%, the timeframe for returning to activity can be upwards of 6-8 months, despite an intensive rehabilitation process. For patients suffering from IAT, conservative management is usually employed as the first line intervention in this pathology, however approximately 30% of patients fail conservative management and require further intervention. Although there is insufficient literature to provide a consensus on the surgical approach which gives the best outcomes, healing of the tendon back to its insertion following surgery is typically slow.
Bioinductive collagen scaffolds (BCIs) have been adopted to augment tendon healing in the shoulder and are increasingly described in the Achilles as a means to enhance standard of care procedures. Early evidence, through case reports/technical notes and small case series across MSR and IAT , describe improvements in patient-reported outcomes and imaging evidence of scaffold integration by 6 months. Robust prospective data in US populations, however, remains sparse.
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.
556 studies on the registry are indexed under Rupture; 96 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 204 observational studies indexed under Rupture.
Browse Rupture studies →OrthoCarolina Research Institute, Inc. is the lead sponsor of 35 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who present as eligible for 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.
Patients who present as eligible for Achilles tendon reconstruction, with or without concomitant calcaneoplasty/bursectomy for insertional Achilles tendinopathy. Fixation of REGENETEN implant to be completed with tendon anchors.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Acute Mid-Substance Rupture:
Insertional Achilles Tendinopathy:
Exclusion Criteria:
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.
Device: REGENETEN
Achilles tendon reconstruction, with or without concomitant calcaneoplasty/bursectomy for insertional Achilles tendinopathy. Fixation of REGENETEN implant to be completed with tendon anchors.
Device: REGENETEN
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.
American Orthopaedic Foot & Ankle Society (AOFAS) ankle/hindfoot score
AOFAS ankle/hindfoot score - Clinician reported score completed at 12 months post Achilles surgical procedure. Scores range from 0 to 100, with healthy ankles receiving 100 points
Time frame: 12 months post surgery
Tendon healing at site of procedure
Tendon healing at site of procedure, answered as a "yes" or "no" to whether the tendon is completely healed as viewed on imaging and clinical assessment
Time frame: 12 months post surgery
Implant absorption
Implant absorption seen on imaging, identified as "None ; Partial ; or Complete absorption seen"
Time frame: 12 months post surgery
Tendon thickness
Tendon thickness seen on imaging
Time frame: 12 months post surgery
Achilles Tendon Total Rupture Score (ATRS)
Achilles Tendon Total Rupture Score (ATRS) (Mid-substance rupture patients only). Each item is graded from 0 (major limitations or severe symptoms) to 10 (no limitations or normal function)
Time frame: preop/screening, 6 week postoperative , 3 months postoperative, 6 months postoperative, and 12 months postoperative
Victorian Institute of Sport Assessment Achilles (VISA-A)
VISA-A (IAT patients only) score completed at preop/screening, 6 week , 3, 6 and 12-month post op review. This is a specific outcome measure to Achilles tendinopathy patient, scored from 0 to 100 points with higher points indicating healthier patients.
Time frame: 6 weeks postoperative , 3 months postoperative, 6 months postoperative, and 12 months postoperative
Visual Analog Scale (VAS)
Pain scale of 0-10 with higher scores indicating more pain.
Time frame: preoperative/screening, 6 weeks postoperative , 3 months postoperative, 6 months postoperative, and 12 months postoperative
Heel-rise test
Heel-rise test: Completed in office at preop/Screening, 3-, 6-, 12-months, under PT supervision if possible.
Time frame: preoperative/Screening, 3 months postoperative, 6 months postoperative, and 12 months postoperative
Achilles Tendon Resting Angle (ATRA)
Achilles Tendon Resting Angle (ATRA): measured by physician. Completed in office at preop/screening, 3-, 6-, 12- months
Time frame: preoperative/screening, 3 months postoperative, 6 months postoperative, and 12 months postoperative
Range of Motion (ROM)
Range of motion: Completed in office at preop/screening, 3-, 6-, 12 months; patient is supine with knee straight
Time frame: preoperative/screening, 3 months, 6 months, and 12 months postoperative
Charlotte Hindfoot Assessment
Charlotte Hindfoot Assessment: Scored between 0 and 100 points, where a higher score indicates better function and less pain.
Time frame: preoperative/screening, 6 weeks postoperative, 3 months postoperative, 6 months postoperative, and 12 months postoperative
Plan to share: Undecided — Undecided
Started Aug 2026 (actual). Primary completion is estimated for Dec 2028, 28 months after the start.
Of 92 non-industry observational studies under Rupture, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 70. This study's planned 28 months is below that.
Counting every sponsor, half of 101 studies reached it within 34 months; a quarter within 16 and three quarters within 78.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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OrthoCarolina Research Institute, Inc.