An interventional study of Reselution V Tibial Intramedullary Fixation System and Reselution VT Tibial Intramedullary Fixation System in Tibial Fractures and Fractures, Open, sponsored by Reselute, Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 22 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Reselute, Inc. · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn whether an antibiotic-releasing nail placed inside the shinbone (tibia) helps prevent infection and supports bone healing in adults with an open shinbone fracture. The study will test two versions of the Reselution Tibial Intramedullary Fixation System: one that releases vancomycin (Reselution V) and one that releases vancomycin and tobramycin (Reselution VT).
The main question it aims to answer is: within 12 months of surgery, how many participants heal without unplanned repeat surgery on the injured leg, have a healed bone on X-ray, and have no serious device-related side effects?
Participants will:
135 studies on the registry are indexed under Tibial Fractures; 37 are open to participants now.
This study's planned enrollment of 317 is above the median of 65 across 91 interventional studies indexed under Tibial Fractures.
Browse Tibial Fractures studies →This is the only study on the registry with Reselute, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Definitive fixation of the open tibial fracture with the Reselution V Tibial Intramedullary Fixation System (vancomycin).
Device: Reselution V Tibial Intramedullary Fixation System
Definitive fixation of the open tibial fracture with the Reselution VT Tibial Intramedullary Fixation System (vancomycin and tobramycin).
Device: Reselution VT Tibial Intramedullary Fixation System
Device-led combination product: titanium tibial intramedullary nail with an internal core loaded with vancomycin for local sustained antibiotic delivery.
Device-led combination product: titanium tibial intramedullary nail with an internal core loaded with vancomycin and tobramycin for local sustained antibiotic delivery.
Percentage of Participants With Composite Success at 12 Months
Composite success requires all of the following through 12 months: (1) no unplanned repeat surgery on the study injury for deep surgical site infection, to promote fracture union, for nail construct removal due to implant failure or migration, or amputation; (2) radiographic fracture union, defined as a modified Radiographic Union Score for Tibial fractures (mRUST) of 10 or greater; and (3) no device-related serious adverse events or device-related serious suspected adverse reactions.
Time frame: 12 months after surgery
Percentage of Participants Without Unplanned Repeat Surgery
Unplanned repeat surgery on the study injury to address infection, wound healing, or fracture union, excluding implant removal for prominence or irritation.
Time frame: 12 and 24 months after surgery
Percentage of Participants With Radiographic Fracture Union
Union defined as a modified Radiographic Union Score for Tibial fractures (mRUST) of 10 or greater.
Time frame: 12 months after surgery
Percentage of Participants Without Device-Related Serious Adverse Events
Includes device-related serious adverse events and device-related serious suspected adverse reactions.
Time frame: Through 12 and 24 months after surgery
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Score
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (lower extremity) T-score. Higher scores indicate better function.
Time frame: 12 and 24 months after surgery
Brief Pain Inventory Score
Brief Pain Inventory scores range from 0 to 10. Higher scores indicate worse pain.
Time frame: 12 and 24 months after surgery
Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Score
Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities T-score. Higher scores indicate better ability to participate.
Time frame: 12 and 24 months after surgery
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Feb 2029, 25 months later.
Of 39 interventional studies with no phase under Tibial Fractures, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 80. This study's planned 25 months is below that.
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 ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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