Complete Mid-portion Achilles RuptureNCT07869121
Achilles Non-SNIS REGENETEN
An observational study of Complete Mid-portion Achilles Rupture, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Complete Mid-portion Achilles Rupture
- What is being tested?
- REGENETEN
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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+
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
About this study
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.
Read the 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.
- Conditions
- Complete Mid-portion Achilles Rupture
- Being tested
- REGENETEN
- Keywords
- achilles rupture, achilles, rupture, Regeneten, Achilles Tendinopathy
- Medical subject headings
- Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGENETENDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: REGENETEN | |
| 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. Receives: Device: REGENETEN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months post surgery
Secondary outcomes (7)
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
Measured: 12 months post surgery
Implant absorption
Implant absorption seen on imaging, identified as "None ; Partial ; or Complete absorption seen"
Measured: 12 months post surgery
Tendon thickness
Tendon thickness seen on imaging
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: preoperative/Screening, 3 months postoperative, 6 months postoperative, and 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start3 Aug 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Complete Mid-portion Achilles RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carroll Jones, MD, Principal investigator, OrthoCarolina Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869121
- Sponsor's protocol ID
- 1181
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Undecided
Publications
Genuth G, Iselin LD. Treating insertional Achilles tendinitis with bio inductive collagen scaffold - Does it improve outcomes? A case series. J Clin Orthop Trauma. 2025 Feb 7;63:102931. doi: 10.1016/j.jcot.2025.102931. eCollection 2025 Apr.
PubMed 40041090Moonot P, Dakhode S. Current concept review of Achilles tendinopathy. J Clin Orthop Trauma. 2024 Feb 23;50:102374. doi: 10.1016/j.jcot.2024.102374. eCollection 2024 Mar.
PubMed 38463138Shoap S, Backer HC, Freibott CE, Ferrer XE, Polzer H, Turner Vosseller J. Rerupture and wound complications following Achilles tendon repair: A systematic review. J Orthop Res. 2023 Apr;41(4):845-851. doi: 10.1002/jor.25419. Epub 2022 Aug 6.
PubMed 35864743Lo IK, Kirkley A, Nonweiler B, Kumbhare DA. Operative versus nonoperative treatment of acute Achilles tendon ruptures: a quantitative review. Clin J Sport Med. 1997 Jul;7(3):207-11. doi: 10.1097/00042752-199707000-00010.
PubMed 9262889Sharma P, Maffulli N. Tendon injury and tendinopathy: healing and repair. J Bone Joint Surg Am. 2005 Jan;87(1):187-202. doi: 10.2106/JBJS.D.01850.
PubMed 15634833Lemme NJ, Li NY, DeFroda SF, Kleiner J, Owens BD. Epidemiology of Achilles Tendon Ruptures in the United States: Athletic and Nonathletic Injuries From 2012 to 2016. Orthop J Sports Med. 2018 Nov 26;6(11):2325967118808238. doi: 10.1177/2325967118808238. eCollection 2018 Nov.
PubMed 30505872Traweger A, Scott A, Kjaer M, Wezenbeek E, Scattone Silva R, Kennedy JG, Butler JJ, Gomez-Florit M, Gomes ME, Snedeker JG, Dakin SG, Wildemann B. Achilles tendinopathy. Nat Rev Dis Primers. 2025 Mar 27;11(1):20. doi: 10.1038/s41572-025-00602-9.
PubMed 40148342Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
PubMed 18929686
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achilles Non-SNIS REGENETEN
- ClinicalTrials.gov ID
- NCT07869121
- Acronym / sponsor ID
- 1181
- Conditions
- Complete Mid-portion Achilles Rupture
- Keywords
- achilles rupture, achilles, rupture, Regeneten, Achilles Tendinopathy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Krakow sutured, bundle-to-bundle repair | – | Device: REGENETENKrakow sutured, bundle-to-bundle repair for mid-substance primary Achilles rupture with REGENETEN augmentation. Fixation of REGENETEN implant to be completed with tendon anchors. |
| Achilles tendon reconstruction | – | Device: REGENETENAchilles tendon reconstruction, with or without concomitant calcaneoplasty/bursectomy for insertional Achilles tendinopathy. Fixation of REGENETEN implant to be completed with tendon anchors. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGENETENThe 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. | Device | Achilles tendon reconstruction, Krakow sutured, bundle-to-bundle repair |
Primary outcome
American Orthopaedic Foot & Ankle Society (AOFAS) ankle/hindfoot score
Time frame: 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
7 secondary outcomes
Tendon healing at site of procedure
Time frame: 12 months post surgery
Implant absorption
Time frame: 12 months post surgery
Tendon thickness
Time frame: 12 months post surgery
Achilles Tendon Total Rupture Score (ATRS)
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)
Time frame: 6 weeks postoperative , 3 months postoperative, 6 months postoperative, and 12 months postoperative
Visual Analog Scale (VAS)
Time frame: preoperative/screening, 6 weeks postoperative , 3 months postoperative, 6 months postoperative, and 12 months postoperative
Heel-rise test
Time frame: preoperative/Screening, 3 months postoperative, 6 months postoperative, and 12 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 40041090Genuth G, Iselin LD. Treating insertional Achilles tendinitis with bio inductive collagen scaffold - Does it improve outcomes? A case series. J Clin Orthop Trauma. 2025 Feb 7;63:102931. doi: 10.1016/j.jcot.2025.102931. eCollection 2025 Apr.
- Background: PubMed 38463138Moonot P, Dakhode S. Current concept review of Achilles tendinopathy. J Clin Orthop Trauma. 2024 Feb 23;50:102374. doi: 10.1016/j.jcot.2024.102374. eCollection 2024 Mar.
- Background: PubMed 35864743Shoap S, Backer HC, Freibott CE, Ferrer XE, Polzer H, Turner Vosseller J. Rerupture and wound complications following Achilles tendon repair: A systematic review. J Orthop Res. 2023 Apr;41(4):845-851. doi: 10.1002/jor.25419. Epub 2022 Aug 6.
- Background: PubMed 9262889Lo IK, Kirkley A, Nonweiler B, Kumbhare DA. Operative versus nonoperative treatment of acute Achilles tendon ruptures: a quantitative review. Clin J Sport Med. 1997 Jul;7(3):207-11. doi: 10.1097/00042752-199707000-00010.
- Background: PubMed 15634833Sharma P, Maffulli N. Tendon injury and tendinopathy: healing and repair. J Bone Joint Surg Am. 2005 Jan;87(1):187-202. doi: 10.2106/JBJS.D.01850.
- Background: PubMed 30505872Lemme NJ, Li NY, DeFroda SF, Kleiner J, Owens BD. Epidemiology of Achilles Tendon Ruptures in the United States: Athletic and Nonathletic Injuries From 2012 to 2016. Orthop J Sports Med. 2018 Nov 26;6(11):2325967118808238. doi: 10.1177/2325967118808238. eCollection 2018 Nov.
- Background: PubMed 40148342Traweger A, Scott A, Kjaer M, Wezenbeek E, Scattone Silva R, Kennedy JG, Butler JJ, Gomez-Florit M, Gomes ME, Snedeker JG, Dakin SG, Wildemann B. Achilles tendinopathy. Nat Rev Dis Primers. 2025 Mar 27;11(1):20. doi: 10.1038/s41572-025-00602-9.
- Background: PubMed 18929686Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
- Individual participant dataSharing planned: Undecided. Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carroll Jones, MD principal investigator
OrthoCarolina Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complete Mid-portion Achilles Rupture, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Orthopaedic Foot & Ankle Society (AOFAS) ankle/hindfoot score (time frame: 12 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07869121, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.