Complete Mid-portion Achilles Rupture
Conditions
Keywords
achilles rupture, achilles, rupture, Regeneten, Achilles Tendinopathy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEREGENETEN
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.
Sponsors
OrthoCarolina Research Institute, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Acute Mid-Substance Rupture: * Clinical diagnosis of complete mid-portion Achilles rupture by experienced physician (Diagnosis confirmation to include presence of positive Thompson test) * Adult patients ≥21 to 70 years old * Acute rupture (≤14 days of initial injury) * Rupture located 2-6cm proximal to calcaneal insertion mid portion * Indicated for surgical procedure Insertional Achilles Tendinopathy: * Diagnosis of insertional Achilles tendinopathy confirmed by imaging and having failed at least 3 months of conservative management. * Adult patients ≥21 to 70 years old * Indicated for surgical procedure
Exclusion criteria
* Achilles tendon retraction \>3cm (Kuwada grade II) * Avulsion injury * Pregnancy or planning to become pregnant * Previously known reaction to bovine * Concurrent lower extremity fracture/ acute polytrauma * Local injections (corticosteroid or biologic) within 6-months of rupture on the injured achilles * Fluoroquinolone use within last 6 months * Diabetes (uncontrolled) * HTN (uncontrolled) * Current smoking * Skin problems over Achilles * Current infection * Open Achilles rupture * Neurovascular disease * Neurological disorder (eg stroke) * Immunosuppressive treatment * Known/ ongoing litigation from the injury in question ( eg workers comp with litigation) * Subjects with insufficient tendon tissue quality for management and protection of the tendon injury using the isolated REGENETEN Bioinductive Implant system * Collagen or connective tissue disorder * BMI 40+
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Orthopaedic Foot & Ankle Society (AOFAS) ankle/hindfoot score | 12 months post surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tendon healing at site of procedure | 12 months post surgery | 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 |
| Implant absorption | 12 months post surgery | Implant absorption seen on imaging, identified as "None ; Partial ; or Complete absorption seen" |
| Tendon thickness | 12 months post surgery | Tendon thickness seen on imaging |
| Achilles Tendon Total Rupture Score (ATRS) | preop/screening, 6 week postoperative , 3 months postoperative, 6 months postoperative, and 12 months postoperative | 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) |
| Victorian Institute of Sport Assessment Achilles (VISA-A) | 6 weeks postoperative , 3 months postoperative, 6 months postoperative, and 12 months postoperative | 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. |
| Visual Analog Scale (VAS) | preoperative/screening, 6 weeks postoperative , 3 months postoperative, 6 months postoperative, and 12 months postoperative | Pain scale of 0-10 with higher scores indicating more pain. |
| Heel-rise test | preoperative/Screening, 3 months postoperative, 6 months postoperative, and 12 months postoperative | Heel-rise test: Completed in office at preop/Screening, 3-, 6-, 12-months, under PT supervision if possible. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCarroll Jones, MD
OrthoCarolina Research Institute, Inc.
Outcome results
None listed